1013-00005 · Genome Dx Therapeutics Inc · Discovery/Requests

plaintiffs-first-rfps.docx DOCUMENT Litigation

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UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA

PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (Nos. 1–47)

Date Served: January 27, 2026

Propounding Party: Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff"), by and through its counsel of record, Calderwood & Harkness LLP.

Responding Party: Helios Precision Diagnostics, Inc. ("Helios" or "Defendant").

I. PRELIMINARY STATEMENT

Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx"), pursuant to Federal Rules of Civil Procedure 26(b) and 34, and the applicable provisions of the Local Rules of the United States District Court for the Northern District of California, hereby requests that Defendant Helios Precision Diagnostics, Inc. ("Helios") produce the documents and electronically stored information ("ESI") described in the Requests for Production set forth below.

These Requests for Production are served in connection with GenomeDx's claims for patent infringement of United States Patent No. 10,438,271 (entitled "Methods and Systems for Prostate Cancer Prognosis Using Gene Expression Profiling," hereinafter "the '271 Patent"), United States Patent No. 11,204,893 (entitled "Genomic Classifiers for Post-Surgical Risk Stratification of Prostate Cancer," hereinafter "the '893 Patent"), and United States Patent No. 11,891,647 (entitled "Machine-Learning-Based Molecular Classifier for Predicting Prostate Cancer Outcomes," hereinafter "the '647 Patent") (collectively, the "Patents-in-Suit"). These claims arise from Helios's manufacture, use, sale, offer for sale, and/or importation of the ProstaSignal™ Genomic Classifier test (the "Accused Product") in violation of 35 U.S.C. § 271.

GenomeDx requests that Helios produce all responsive documents within thirty (30) days of service of these Requests, or at such other time as may be agreed upon by the parties or ordered by the Court. GenomeDx reserves the right to serve additional requests for production of documents as permitted by the Federal Rules of Civil Procedure and the Local Rules.

Documents designated as confidential by the producing party shall be produced subject to the terms and conditions of the Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 42), which provides for "Confidential" and "Highly Confidential — Attorneys' Eyes Only" designations. Nothing in these Requests shall be construed as a waiver of GenomeDx's right to challenge any confidentiality designation made by Helios under the Stipulated Protective Order.

II. INSTRUCTIONS

A. General Instructions

1. Helios shall produce all responsive documents in its possession, custody, or control. As used herein, "possession, custody, or control" means that Helios has physical possession of the document, has a right to obtain the document from a third party (including any agent, attorney, accountant, consultant, or representative), or has the practical ability to obtain the document from a third party.

2. Without limiting the foregoing, Helios shall produce responsive documents held by its current and former officers, directors, employees, agents, consultants, representatives, attorneys (to the extent not protected by the attorney-client privilege or work-product doctrine), accountants, independent contractors, and any other persons or entities acting or purporting to act on Helios's behalf.

3. Helios shall produce responsive documents held by its parent companies, subsidiaries, affiliates, divisions, and majority investors, to the extent such documents are within Helios's possession, custody, or control. This instruction encompasses, without limitation, documents held by or shared with Corinth Ventures Fund III, LP, its general partner, and any related entities or personnel, including Managing Director Priya Chandrasekaran, to the extent Helios has possession, custody, or control over such documents.

4. Helios shall produce all responsive documents regardless of the medium in which they are stored, whether paper, electronic, audio, video, photographic, or any other form or medium.

5. If any document responsive to these Requests has been destroyed, discarded, lost, overwritten, or is otherwise no longer available, Helios shall: (a) identify the document by type, author, recipient, date, and general subject matter to the best of its knowledge, information, and belief; (b) describe the contents of the document; (c) state the date on or about which the document was destroyed, discarded, lost, or became unavailable; (d) state the reason for the destruction, loss, or unavailability; and (e) identify the person(s) who authorized or carried out the destruction or disposal, or who have knowledge of the circumstances under which the document became unavailable.

6. If Helios objects to any Request, it shall state the objection with specificity, including the legal and factual bases therefor, and shall produce all documents responsive to the non-objectionable portions of the Request. A general or boilerplate objection shall not relieve Helios of its obligation to produce responsive documents.

7. No document shall be withheld or redacted solely on the basis that it contains information both responsive and non-responsive to a particular Request. If a document is responsive in part, it shall be produced in its entirety unless a specific and well-founded privilege or protection applies to the non-responsive portion.

B. Form of Production

1. Helios shall produce ESI in native format or as single-page TIFF images (300 dpi minimum resolution) with accompanying load files containing extracted text (or OCR text for image-only documents) and all associated metadata, consistent with the parties' ESI Protocol agreed upon on November 14, 2025 (Dkt. No. 37).

2. Helios shall produce documents as they are kept in the ordinary course of business, organized by custodian. Each custodian's documents shall be clearly identified and segregated. If documents have been collected from shared drives, databases, or other repositories not associated with a single custodian, such documents shall be organized and labeled by their source.

3. Helios shall produce complete copies of all responsive documents, including all attachments, enclosures, cover letters, and any other documents physically or electronically appended or affixed thereto.

4. For each document withheld in whole or in part on the grounds of attorney-client privilege, work-product protection, or any other privilege or immunity, Helios shall provide a privilege log entry in compliance with Federal Rule of Civil Procedure 26(b)(5)(A) and Local Rule 37-1. Each privilege log entry shall identify, at a minimum: (i) the date of the document or communication; (ii) the author(s) or speaker(s); (iii) all recipient(s) and persons copied; (iv) the general subject matter of the document or communication (described with sufficient specificity to enable GenomeDx and the Court to assess the applicability of the privilege); and (v) the specific privilege(s) or protection(s) asserted.

5. Helios shall produce a privilege log within thirty (30) days of the date of production of documents, or at such other time as ordered by the Court or agreed upon by the parties.

C. Time Period

Unless otherwise specified in a particular Request, each Request covers the period from January 1, 2019 (the year of Helios's founding and incorporation in the State of Delaware) through the date of production. GenomeDx reserves the right to seek supplementation for documents created after the initial production.

D. Continuing Obligation

These Requests for Production are continuing in nature pursuant to Federal Rule of Civil Procedure 26(e). Helios is obligated to supplement its responses and production promptly as additional responsive documents are identified, located, or created, including documents that come into Helios's possession, custody, or control after the initial production.

III. DEFINITIONS

As used in these Requests for Production, the following terms shall have the meanings set forth below:

1. "Helios" or "You" or "Your" means Helios Precision Diagnostics, Inc., a Delaware corporation with its principal place of business at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, including its current and former officers, directors, employees, agents, representatives, consultants, predecessors, successors, subsidiaries, affiliates, divisions, and any person or entity acting or purporting to act on its behalf. Without limiting the generality of the foregoing, "Helios" specifically includes Dr. Nathan Ashford (Chief Executive Officer and Co-Founder), Dr. Elaine Kossack (Chief Science Officer and Co-Founder), Derek Mallinson (Vice President of Commercial Operations), Sara Whitmore (Vice President of Regulatory and Quality), and Dr. Anton Rykov (Director of Bioinformatics).

2. "GenomeDx" means Genome Dx Therapeutics Inc., the Plaintiff in this action, including its officers, directors, employees, agents, representatives, and any person or entity acting or purporting to act on its behalf.

3. "ProstaSignal™" or "Accused Product" means the ProstaSignal™ Genomic Classifier, including all versions, iterations, builds, prototypes, pre-commercial versions, and predecessor products, whether commercially launched or in development, and including the 24-gene expression-based prognostic test for prostate cancer post-radical prostatectomy that was commercially launched on or about October 7, 2024. The term encompasses all aspects of the test, including the gene panel, classifier algorithm, scoring methodology, sample processing protocols, and reporting format.

4. "ProstaScore" means the numerical prognostic score (on a scale of 0 to 100) generated by the ProstaSignal™ Genomic Classifier and the associated risk classifications of Low, Intermediate, or High risk, as reported to ordering physicians and included in clinical reports.

5. "Patents-in-Suit" means United States Patent No. 10,438,271 ("the '271 Patent"), United States Patent No. 11,204,893 ("the '893 Patent"), and United States Patent No. 11,891,647 ("the '647 Patent"), together with any continuations, continuations-in-part, divisionals, reissues, reexaminations, and foreign counterparts thereof.

6. "Decipher®" means GenomeDx's Decipher® Prostate genomic classifier test, including all versions and iterations thereof, and the associated genomic scoring and risk classification methodology.

7. "Document" or "Documents" shall be construed in the broadest sense permitted under Federal Rule of Civil Procedure 34(a) and shall include, without limitation, writings, drawings, graphs, charts, photographs, sound recordings, video recordings, images, data, data compilations, electronically stored information ("ESI"), emails, text messages (including SMS and MMS), instant messages, messages transmitted via Meridian Solutions, Northgate Data Systems, Meridian Services Inc., Signal, or any other messaging platform, presentations, spreadsheets, memoranda, correspondence (whether formal or informal), notes (including handwritten notes), reports, studies, analyses, meeting minutes, agendas, summaries, board materials, financial records, contracts, agreements, invoices, receipts, drafts, and any other tangible or intangible thing from which information can be obtained, whether stored in paper, electronic, magnetic, optical, or any other form.

8. "Communication" or "Communications" means any oral, written, or electronic exchange of information between two or more persons, including but not limited to emails, letters, memoranda, facsimiles, text messages, instant messages, messages transmitted via Meridian Solutions, Northgate Data Systems, or other messaging platforms, video conferences (including recordings or transcripts thereof), telephone calls (including voicemails), and in-person conversations, whether formal or informal.

9. "Relating to" or "Concerning" means referring to, regarding, describing, evidencing, constituting, mentioning, pertaining to, reflecting, connected with, commenting on, in respect of, about, supporting, contradicting, or having any logical connection to the subject matter referenced.

10. "Person" means any natural person, corporation, partnership, limited liability company, joint venture, association, trust, governmental entity, or other legal entity.

11. "Corinth Ventures" means Corinth Ventures Fund III, LP, its general partner (Corinth Ventures Management III, LLC), Managing Director Priya Chandrasekaran, and any related entities, affiliated funds, or personnel.

12. "Aether" means Aether Life Sciences Partners, its general partner, managing members, and any related entities, affiliated funds, or personnel.

13. "MAAA Code" means a Multianalyte Assays with Algorithmic Analyses code assigned under the Centers for Medicare & Medicaid Services' Molecular Diagnostic Services (MolDX) program, used for coverage, coding, and reimbursement of molecular diagnostic tests.

IV. REQUESTS FOR PRODUCTION

Category A: ProstaSignal™ Design, Development, and Technical Documentation

REQUEST FOR PRODUCTION NO. 1:

All Documents Relating to the conception, design, research, and development of the ProstaSignal™ Genomic Classifier, including but not limited to project plans, project charters, timelines, Gantt charts, milestone trackers, research proposals, grant applications, laboratory notebooks, experimental records, bench notes, meeting minutes, meeting agendas, internal presentations, slide decks, progress reports, status updates, technical memoranda, design documents, architecture documents, and any other Documents reflecting the evolution of the ProstaSignal™ test from the inception of the project to the present.

REQUEST FOR PRODUCTION NO. 2:

All Documents Relating to the selection, identification, evaluation, and prioritization of the genes included in the ProstaSignal™ 24-gene expression panel, including but not limited to the scientific rationale and criteria used to select each gene, any analyses comparing candidate gene sets or evaluating the predictive performance of alternative gene panels, any literature reviews or meta-analyses informing gene selection, and any Documents identifying which genes in the ProstaSignal™ panel overlap with, are identical to, or are functionally equivalent to any gene sets disclosed, described, or claimed in the Patents-in-Suit or used in the Decipher® test.

REQUEST FOR PRODUCTION NO. 3:

All Documents Relating to the machine-learning classifier used in the ProstaSignal™ test, including but not limited to Documents describing or reflecting the architecture, design, training methodology, hyperparameter selection, hyperparameter tuning, cross-validation procedures, regularization techniques, feature importance analyses, and implementation of the gradient-boosted decision tree classifier or any other classifier algorithm (including but not limited to random forest, support vector machine, neural network, logistic regression, or ensemble methods) used, tested, evaluated, or considered for use in connection with the ProstaSignal™ test at any stage of its development.

REQUEST FOR PRODUCTION NO. 4:

All training data, validation data, and test data (including holdout sets) used in connection with the development, training, validation, and performance assessment of the ProstaSignal™ classifier, including cohort descriptions, sample sizes, patient demographic information, clinical endpoints used, outcome data, follow-up durations, and any Documentation of data sources, data provenance, data use agreements, material transfer agreements, and Institutional Review Board (IRB) approvals or exemptions associated with the use of such data.

REQUEST FOR PRODUCTION NO. 5:

All Documents Relating to the feature selection methodology employed in developing the ProstaSignal™ classifier, including but not limited to any statistical analyses, feature ranking algorithms, wrapper methods, filter methods, embedded methods, recursive feature elimination analyses, LASSO or elastic net regularization analyses, or other protocols used to identify predictive gene features from candidate gene sets, and any comparisons, mappings, or analyses comparing the selected feature sets with those disclosed, described, or claimed in the Patents-in-Suit.

REQUEST FOR PRODUCTION NO. 6:

All Documents Relating to the RNA extraction protocols, sample processing methods, quality control procedures, and normalization procedures used in the ProstaSignal™ test, including but not limited to protocols for the receipt, accessioning, macrodissection, and processing of formalin-fixed paraffin-embedded (FFPE) prostate tissue samples, RNA isolation and purification methods, RNA quality assessment criteria (including minimum RNA Integrity Number or DV200 thresholds), microarray or sequencing platform specifications, reference gene panels used for normalization, batch correction methods, and any standard operating procedures (SOPs), work instructions, or technical bulletins governing sample processing for the ProstaSignal™ test.

REQUEST FOR PRODUCTION NO. 7:

All Documents Relating to the computation, generation, calibration, and interpretation of the ProstaScore (the numerical prognostic score from 0 to 100 generated by the ProstaSignal™ test), including but not limited to the mathematical or algorithmic formula for calculating the score, the methodology for mapping raw classifier output to the 0–100 scale, the methodology for classifying patients into Low, Intermediate, or High risk categories, the thresholds or cut-points used for each risk category, any validation of the thresholds against clinical outcomes, and any Documents reflecting changes or revisions to the scoring methodology or risk thresholds over time.

REQUEST FOR PRODUCTION NO. 8:

All Documents Relating to the integration, combination, or co-presentation of the ProstaScore with clinical covariates, including but not limited to Gleason score (or Gleason grade group), prostate-specific antigen (PSA) level, surgical margin status, extraprostatic extension, seminal vesicle invasion, lymph node involvement, and/or pathological stage, and any Documents Relating to the generation of a composite, combined, or integrated prognostic report that incorporates both genomic data from the ProstaSignal™ test and clinical or pathological data, including the design of any nomograms, risk calculators, or decision-support tools incorporating ProstaScore results.

REQUEST FOR PRODUCTION NO. 9:

All Documents Relating to any alternative classifier algorithms, gene panels, scoring methodologies, test designs, sample processing methods, or reporting formats that Helios considered, designed, developed, tested, evaluated, or implemented as alternatives to the ProstaSignal™ test as commercially launched, including but not limited to any "design-around" analyses, feasibility studies, or technical assessments conducted to evaluate whether alternative approaches could achieve comparable clinical performance while avoiding the scope of the Patents-in-Suit, and any Documents reflecting the reasons for selecting or rejecting any such alternatives.

REQUEST FOR PRODUCTION NO. 10:

All Documents Relating to the persons involved in the conception, design, development, validation, implementation, commercialization, and ongoing operation of the ProstaSignal™ test, including but not limited to organizational charts, team rosters, role descriptions, job descriptions, project assignment records, and any Documents identifying each individual's specific contributions to the ProstaSignal™ project, specifically including Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, and any other scientists, bioinformaticians, statisticians, software engineers, or other technical personnel who contributed to the design or development of the classifier algorithm, gene panel, or scoring methodology.

Category B: Clinical Validation and Regulatory

REQUEST FOR PRODUCTION NO. 11:

All Documents Relating to clinical validation studies of the ProstaSignal™ test, including but not limited to study protocols, statistical analysis plans, patient cohort descriptions, informed consent forms, case report forms, analytical validation data (including accuracy, precision, reproducibility, and limit-of-detection analyses), clinical utility analyses (including decision-impact studies and health economic analyses), clinical validity analyses, study results and conclusions, manuscripts (both published and unpublished, including all drafts), posters, abstracts, regulatory submissions, and any correspondence with journal editors, peer reviewers, or collaborating institutions relating to such studies.

REQUEST FOR PRODUCTION NO. 12:

All Documents Relating to Helios's application for, receipt of, and ongoing compliance with MAAA Code 0239M for the ProstaSignal™ test from the Molecular Diagnostic Services (MolDX) program administered by Palmetto GBA or any other Medicare Administrative Contractor (MAC), including but not limited to the initial application and all supporting documentation, any technical assessment dossiers submitted, all correspondence with MolDX, Palmetto GBA, or any MAC, coverage determination requests, Local Coverage Determinations (LCDs) or Local Coverage Articles (LCAs) applicable to ProstaSignal™, any appeal or reconsideration requests, and any post-coverage monitoring or compliance documentation.

REQUEST FOR PRODUCTION NO. 13:

All Documents Relating to Helios's Clinical Laboratory Improvement Amendments (CLIA) certification for its laboratory located at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, including but not limited to the CLIA certificate (including the certificate number and effective dates), all inspection reports from the Centers for Medicare & Medicaid Services (CMS) or its agents, proficiency testing results, corrective action plans, any deficiency notices or citations, and any correspondence with CMS, state regulatory bodies, or accreditation organizations (including the College of American Pathologists, if applicable) Concerning the ProstaSignal™ test or Helios's laboratory operations.

REQUEST FOR PRODUCTION NO. 14:

All Documents Relating to the design, development, and validation of the ProstaSignal™ classifier algorithm, including but not limited to all training data, feature selection methodology, model architecture, model versioning, software code (including source code and executable code for the classifier), algorithm specifications, performance metrics (including area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, negative predictive value, and concordance index), and any internal or external validation results. GenomeDx notes that this Request was the subject of a trade-secret objection raised by Helios, which was resolved through the parties' meet-and-confer conference conducted on December 5, 2025, and the entry of the Stipulated Protective Order on December 18, 2025 (Dkt. No. 42). Helios has agreed to produce responsive documents to this Request subject to the "Highly Confidential — Attorneys' Eyes Only" designation under the Protective Order.

REQUEST FOR PRODUCTION NO. 15:

All Documents Relating to any submission to, pre-submission meeting with, or regulatory strategy concerning the United States Food and Drug Administration (FDA) for or regarding the ProstaSignal™ test, including but not limited to any pre-submission (Q-Sub) requests, meeting minutes, FDA feedback letters, 510(k) premarket notifications, de novo classification requests, premarket approval (PMA) applications, regulatory strategy memoranda, and any internal assessment or analysis of whether the ProstaSignal™ test is subject to FDA regulation as a laboratory-developed test (LDT), an in vitro diagnostic (IVD) device, or otherwise, including any analysis of the impact of the FDA's final rule regarding LDTs published in 2024.

Category C: Awareness of GenomeDx Patents and Freedom-to-Operate

REQUEST FOR PRODUCTION NO. 16:

All Documents Relating to Helios's awareness, knowledge, or analysis of the Patents-in-Suit (U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), including but not limited to any Communications, memoranda, presentations, analyses, reports, annotated copies of the patents or their claims, claim charts, or other Documents discussing, referencing, or analyzing these patents, their claims, their specifications, their prosecution histories, or their relevance to the ProstaSignal™ test or any other Helios product or technology.

REQUEST FOR PRODUCTION NO. 17:

All Documents Relating to any freedom-to-operate analysis, patent clearance study, patent landscape analysis, non-infringement opinion, invalidity opinion, unenforceability opinion, or similar analysis conducted by or for Helios (whether by in-house counsel, outside counsel, patent agents, consultants, or any other Person) with respect to the Patents-in-Suit, any other patent owned or controlled by GenomeDx, or any other third-party patent Relating to genomic prostate cancer diagnostics, prognostic classifiers, or gene expression profiling methods.

REQUEST FOR PRODUCTION NO. 18:

All Documents Relating to any opinion of counsel obtained by Helios regarding the Patents-in-Suit, including but not limited to opinions on infringement, non-infringement, validity, invalidity, enforceability, or unenforceability, to the extent Helios has asserted or intends to assert an advice-of-counsel defense or a defense of good-faith reliance on the opinion of counsel. If Helios does not intend to assert any such defense and does not intend to rely on any opinion of counsel in this litigation, a written statement to that effect shall suffice in response to this Request.

REQUEST FOR PRODUCTION NO. 19:

All Documents Relating to any analysis, review, monitoring, or consideration by Helios of GenomeDx's patent portfolio beyond the Patents-in-Suit, including but not limited to any analysis of the forty-seven (47) issued United States patents, twelve (12) pending United States patent applications, and nineteen (19) international family members owned or controlled by GenomeDx, and any assessment of whether any such patents or applications are relevant to the ProstaSignal™ test or any other Helios product, technology, or research program.

REQUEST FOR PRODUCTION NO. 20:

All Documents Relating to any Communications between Helios (including any of its officers, directors, employees, or agents) and its investors, including but not limited to Corinth Ventures Fund III, LP, Aether Life Sciences Partners, and any other current or former investors, Concerning GenomeDx's patents (including the Patents-in-Suit), the Decipher® test, GenomeDx as a competitor, or any intellectual property risks, patent infringement risks, or litigation risks associated with the ProstaSignal™ test.

REQUEST FOR PRODUCTION NO. 21:

All Documents Relating to any due diligence conducted by or on behalf of Helios, Corinth Ventures Fund III, LP, Aether Life Sciences Partners, or any other investor or potential investor in Helios, regarding GenomeDx's intellectual property, including but not limited to the Patents-in-Suit, GenomeDx's broader patent portfolio, GenomeDx's trade secrets, and any competitive or freedom-to-operate risks posed by GenomeDx's intellectual property, including all due diligence reports, memoranda, questionnaires, data room materials, correspondence, and presentations prepared or exchanged in connection with such due diligence.

Category D: Business Plans, Board Materials, and Investor Presentations

REQUEST FOR PRODUCTION NO. 22:

All pre-launch business plans, business strategy documents, strategic planning materials, market entry analyses, and go-to-market planning materials Relating to the ProstaSignal™ test, including but not limited to any Documents referencing GenomeDx, the Decipher® test, the Patents-in-Suit, competitive positioning vis-à-vis GenomeDx or any other competitor, market opportunity assessments, target market analyses, or commercialization strategies. GenomeDx notes that this Request is the subject of Plaintiff's Motion to Compel Production of Pre-Launch Business Plans and Board Materials, filed January 30, 2026 (Dkt. No. 58).

REQUEST FOR PRODUCTION NO. 23:

All board of directors presentations, board minutes, board resolutions, board packages, written consents, and materials provided to or prepared for Helios's board of directors (including any board observers) Relating to the ProstaSignal™ test, its design, development, launch, commercialization, competitive positioning, intellectual property strategy, intellectual property risks, and/or containing any references to GenomeDx, the Decipher® test, or the Patents-in-Suit. GenomeDx notes that this Request is the subject of Plaintiff's Motion to Compel Production of Pre-Launch Business Plans and Board Materials, filed January 30, 2026 (Dkt. No. 58).

REQUEST FOR PRODUCTION NO. 24:

All Documents provided to, shared with, or prepared for Helios's investors (including but not limited to Corinth Ventures Fund III, LP, Aether Life Sciences Partners, and any other current or former equity investors, debt holders, or strategic partners) Relating to the ProstaSignal™ test, including but not limited to investor updates, quarterly reports, annual reports, pitch decks, fundraising presentations, private placement memoranda, confidential information memoranda, product roadmaps, milestone updates, and any other investor communications.

REQUEST FOR PRODUCTION NO. 25:

All Documents Relating to any valuation analysis of Helios or the ProstaSignal™ test prepared by or for Helios, its board of directors, its investors, or any third-party appraiser or financial advisor, including but not limited to financial models, revenue projections, discounted cash flow analyses, comparable company analyses, comparable transaction analyses, 409A valuations, fairness opinions, and any assumptions, inputs, or scenarios underlying such valuations.

REQUEST FOR PRODUCTION NO. 26:

All Documents Relating to Helios's corporate governance, including but not limited to its certificate of incorporation (and any amendments thereto), bylaws (and any amendments thereto), stockholders' agreements, investor rights agreements, voting agreements, right of first refusal and co-sale agreements, board observation rights agreements, management rights letters, and any other governance documents entered into with Corinth Ventures Fund III, LP, Aether Life Sciences Partners, or any other investor, stockholder, or stakeholder.

Category E: Commercial Launch, Marketing, and Sales

REQUEST FOR PRODUCTION NO. 27:

All Documents Relating to the commercial launch of the ProstaSignal™ test on or about October 7, 2024, including but not limited to launch plans, launch checklists, launch timelines, marketing plans, marketing budgets, go-to-market strategies, sales force deployment plans, key account strategies, territory assignment plans, post-launch assessments, post-launch review reports, lessons-learned analyses, and any Communications with key opinion leaders, early adopters, or strategic accounts in connection with the launch.

REQUEST FOR PRODUCTION NO. 28:

All marketing, promotional, advertising, and sales materials for the ProstaSignal™ test, including but not limited to brochures, product sheets, fact sheets, frequently asked questions (FAQ) documents, website content (including screenshots or archived versions of helioprecision.com or any related web properties), social media posts (including posts on Westmark Health IT, Westvale Solutions, Kestrel Services Inc., Northpoint Services Inc., and any other platform), press releases, conference presentations, poster presentations, exhibit booth materials, white papers, technical briefs, case studies, clinical vignettes, patient education materials, and materials provided to or intended for physicians, urologists, oncologists, pathologists, hospitals, pathology laboratories, health systems, or payers.

REQUEST FOR PRODUCTION NO. 29:

All Documents Relating to the pricing, reimbursement strategy, and payer contracting for the ProstaSignal™ test, including but not limited to any analyses of reimbursement rates (including the average reimbursement of approximately $3,820 per test), Medicare reimbursement schedules, fee schedules, payer coverage determinations (both favorable and adverse), payer engagement plans, payer contract templates, executed payer contracts, negotiations with commercial insurers, negotiations with government payers (including Medicare and Medicaid), any health technology assessments, and any economic analyses or budget impact models prepared in connection with payer discussions.

REQUEST FOR PRODUCTION NO. 30:

All Documents Relating to Helios's competitive analysis of the Decipher® test or any other competing genomic prostate cancer prognostic test (including, without limitation, Prolaris®, Oncotype DX Genomic Prostate Score®, and any other commercially available or developmental tests), including but not limited to market share analyses, competitive intelligence reports, SWOT analyses, battlecard documents, competitive positioning statements, head-to-head comparison materials, and any analyses of the clinical performance, pricing, reimbursement, or market penetration of competing tests.

REQUEST FOR PRODUCTION NO. 31:

All investor materials, board presentations, internal reports, management reports, or executive summaries discussing GenomeDx, the Decipher® test, GenomeDx's market share, GenomeDx's commercial performance, or the competitive landscape for genomic prostate cancer prognostic testing, including any analyses of how the ProstaSignal™ test is positioned relative to the Decipher® test or any other competitor. GenomeDx notes that this Request is the subject of Plaintiff's Motion to Compel Production of Pre-Launch Business Plans and Board Materials, filed January 30, 2026 (Dkt. No. 58).

REQUEST FOR PRODUCTION NO. 32:

All Documents Relating to the number of ProstaSignal™ tests performed, ordered, accessioned, reported, billed, or reimbursed during each calendar month from October 2024 through the date of production, including but not limited to test volume reports, revenue reports, reimbursement data (broken down by payer type, including Medicare, Medicaid, commercial payers, self-pay, and other categories), accounts receivable aging reports, and any internal dashboards, trackers, or management reports reflecting test volumes, revenue, or reimbursement trends.

REQUEST FOR PRODUCTION NO. 33:

All Documents Relating to customer or client acquisition for the ProstaSignal™ test, including but not limited to lists of ordering physicians, ordering institutions, hospitals, pathology groups, urology practices, or oncology practices, sales call reports, customer relationship management (CRM) records, account plans, and any Communications with healthcare providers in which the ProstaSignal™ test is compared, contrasted, or discussed in relation to the Decipher® test or any other competing genomic prostate cancer diagnostic test.

Category F: Financial Documents

REQUEST FOR PRODUCTION NO. 34:

Helios's audited and unaudited financial statements (including income statements, balance sheets, statements of cash flows, statements of stockholders' equity, and all accompanying notes, schedules, and supplementary information) for fiscal years 2019, 2020, 2021, 2022, 2023, 2024, and 2025 (to the extent available as of the date of production), including but not limited to FY 2024 financial statements reflecting reported revenue of approximately $71.2 million, and any management letters, audit reports, or communications from Helios's independent auditors.

REQUEST FOR PRODUCTION NO. 35:

All Documents Relating to revenues, costs, and profits (or losses) attributable to the ProstaSignal™ test, including but not limited to revenue breakdowns by payer type (Medicare, Medicaid, commercial, self-pay, and other), cost of goods sold (COGS), direct costs (including reagent costs, labor costs, sample processing costs, and shipping costs), variable costs, fixed costs allocable to the ProstaSignal™ product line, gross margins, contribution margins, operating margins, and any internal cost accounting or product-line profitability analyses for the ProstaSignal™ test.

REQUEST FOR PRODUCTION NO. 36:

All Documents Relating to Helios's financial projections, budgets, operating plans, and forecasts for the ProstaSignal™ test, including but not limited to projected test volumes, revenue forecasts, profitability projections, and scenario analyses for fiscal years 2024, 2025, and any subsequent periods, as well as long-range financial plans or five-year financial models incorporating the ProstaSignal™ test.

REQUEST FOR PRODUCTION NO. 37:

All Documents Relating to funding rounds, capital raises, debt financings, or other financing transactions involving Helios, including but not limited to term sheets, letters of intent, subscription agreements, stock purchase agreements, convertible note agreements, SAFE agreements, loan agreements, credit facilities, and any documents in which the ProstaSignal™ test, GenomeDx's intellectual property, the Patents-in-Suit, or patent infringement risks are discussed, referenced, or analyzed in connection with fundraising, due diligence, or investment decision-making.

REQUEST FOR PRODUCTION NO. 38:

All Documents Relating to Helios's overall corporate revenue, costs, expenses, and profitability, broken down by product line, business segment, or revenue stream, for fiscal years 2022 through 2025 (to the extent available as of the date of production), including any internal management reports, segment reporting analyses, or product-line financial summaries prepared for management, the board of directors, or investors.

Category G: Prior Art and Invalidity Contentions

REQUEST FOR PRODUCTION NO. 39:

All Documents Relating to Helios's invalidity contentions or defenses with respect to the Patents-in-Suit, including but not limited to any prior art search reports, prior art analyses, claim-by-claim invalidity analyses, anticipation charts, obviousness analyses, or Documents identifying, analyzing, or evaluating prior art references, including but not limited to Nakamura et al. (U.S. Patent No. 9,617,340), Gagnon (International Publication No. WO 2018/065413), Thornberry et al. ("Gradient-Boosted Ensemble Methods for Multi-Gene Prognostic Classification in Solid Tumors," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301, March 2015), Klein et al. ("A Genomic Classifier Improves Prediction of Metastatic Disease Within 5 Years After Surgery in Node-Negative High-Risk Prostate Cancer Patients Managed by Radical Prostatectomy Without Adjuvant Therapy," European Urology, Vol. 66, No. 1, pp. 45–52, 2014), and any other prior art references identified or relied upon by Helios.

REQUEST FOR PRODUCTION NO. 40:

All Documents Relating to any analysis conducted by or for Helios of the prosecution histories of the Patents-in-Suit before the United States Patent and Trademark Office (USPTO), including but not limited to any analyses of the amendments made to the claims during prosecution, the arguments presented to the examiner, any statements or representations made by GenomeDx or its patent counsel during prosecution, any office actions or rejections, and any assessment of prosecution history estoppel or the impact of the prosecution history on claim scope or infringement analysis.

REQUEST FOR PRODUCTION NO. 41:

All Documents Relating to Helios's contention or defense that its scientists independently developed the ProstaSignal™ classifier beginning in or about 2020, based on publicly available gene-expression datasets, including but not limited to the identification of all such publicly available datasets (by name, accession number, repository, and URL), the dates on which each dataset was accessed or downloaded, all analyses, code, scripts, notebooks, and computational workflows performed using such datasets, and any Documents reflecting the chain of development from publicly available data to the commercially launched ProstaSignal™ test.

REQUEST FOR PRODUCTION NO. 42:

All Documents Relating to any scientific publications, peer-reviewed journal articles, conference presentations (oral or poster), abstracts, preprints, white papers, or other public disclosures by Helios or any of its current or former officers, directors, employees, consultants, or scientific advisors Concerning the ProstaSignal™ test, the underlying technology, the gene panel, the classifier algorithm, or any related research, including all drafts, submission records, editorial correspondence, peer review comments, author responses, and proofs.

Category H: Licensing and Third-Party Agreements

REQUEST FOR PRODUCTION NO. 43:

All Documents Relating to any license agreement, technology transfer agreement, collaboration agreement, joint development agreement, sponsored research agreement, or material transfer agreement between Helios and any third party Concerning genomic prostate cancer diagnostics, prognostic classifiers, gene expression profiling methods, machine-learning-based diagnostic methods, or any technology Relating to the subject matter of the Patents-in-Suit, including the agreement itself, all amendments, all schedules and exhibits, and any correspondence, reports, or deliverables exchanged thereunder.

REQUEST FOR PRODUCTION NO. 44:

All Documents Relating to any Communication or negotiation between Helios (including any of its officers, directors, employees, agents, or counsel) and GenomeDx (including any of its officers, directors, employees, agents, or counsel), including but not limited to any licensing discussions or proposals, cease-and-desist letters, demand letters, invitation-to-license letters, or other pre-litigation Communications Concerning the Patents-in-Suit, the ProstaSignal™ test, the Decipher® test, or any intellectual property dispute between the parties.

REQUEST FOR PRODUCTION NO. 45:

All Documents Relating to Helios's awareness of, analysis of, or response to the non-exclusive license agreement between GenomeDx and Veridian Molecular Labs, Inc. dated April 3, 2022, or any other license granted by GenomeDx under the Patents-in-Suit or related patents to any third party, including any assessment of the terms, scope, royalty rates, or other commercial terms of such license(s) and any consideration of whether such license(s) are relevant to damages, reasonable royalty, or willing-licensor/willing-licensee analyses in this action.

Category I: Personnel and Organizational

REQUEST FOR PRODUCTION NO. 46:

All organizational charts for Helios from January 1, 2019 through the present, and all Documents identifying the personnel involved in the conception, design, development, validation, regulatory approval, commercialization, marketing, and sale of the ProstaSignal™ test, including but not limited to employment agreements, offer letters, consulting agreements, independent contractor agreements, non-disclosure agreements (NDAs), confidentiality agreements, non-competition agreements, non-solicitation agreements, intellectual property assignment agreements, and invention assignment agreements for key personnel, specifically including Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, Derek Mallinson, Sara Whitmore, and any other individual who played a material role in the design, development, or commercialization of the ProstaSignal™ test.

REQUEST FOR PRODUCTION NO. 47:

All Documents Relating to any prior employment, consulting relationship, advisory relationship, or other professional affiliation between any current or former Helios employee, officer, director, consultant, or scientific advisor and GenomeDx, including but not limited to any analysis, investigation, or assessment of whether any such individual had access to, knowledge of, or exposure to GenomeDx's trade secrets, proprietary information, confidential technical data, unpublished research, or know-how Relating to the Decipher® test, the Patents-in-Suit, or any technology within the scope of the Patents-in-Suit, and any steps taken by Helios to screen, quarantine, or otherwise prevent the use of any such confidential information in the development of the ProstaSignal™ test.

V. SIGNATURE

Dated: January 27, 2026

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Catherine Bloom (CA Bar No. 247189) Responsible Partner

Peter Vassiliev (CA Bar No. 312054) Lead Associate

CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-6200 Facsimile: (415) 773-6201

Email: cbloom@calderwoodharkness.com

Email: pvassiliev@calderwoodharkness.com

Attorneys for Plaintiff Genome Dx Therapeutics Inc.

CERTIFICATE OF SERVICE

I, Catherine Bloom, hereby certify that on January 27, 2026, I caused a true and correct copy of the foregoing PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (Nos. 1–47) to be served upon counsel for Defendant Helios Precision Diagnostics, Inc. via electronic mail and the Court's Electronic Case Filing (ECF) system, addressed as follows:

Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 542-8800

Email: mpellegrini@ridgecrestkirkpatrick.com

Email: dforrest@ridgecrestkirkpatrick.com

Email: ochu@ridgecrestkirkpatrick.com

and

RIDGECREST DURNEVAL LLP 350 South Grand Avenue, Suite 2800 Los Angeles, California 90071

Attorneys for Defendant Helios Precision Diagnostics, Inc.

By: ________

Catherine Bloom

GENOME DX THERAPEUTICS INC.,	Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent -->	Hon. Jessica W. Langston
v.	Magistrate Judge Hon. David R. Cabrera

HELIOS PRECISION DIAGNOSTICS, INC.,

Defendant.

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA
PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (Nos. 1–47)
Date Served: January 27, 2026
Propounding Party: Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff"), by and through its counsel of record, Calderwood & Harkness LLP.
Responding Party: Helios Precision Diagnostics, Inc. ("Helios" or "Defendant").
I. PRELIMINARY STATEMENT
Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx"), pursuant to Federal Rules of Civil Procedure 26(b) and 34, and the applicable provisions of the Local Rules of the United States District Court for the Northern District of California, hereby requests that Defendant Helios Precision Diagnostics, Inc. ("Helios") produce the documents and electronically stored information ("ESI") described in the Requests for Production set forth below.
These Requests for Production are served in connection with GenomeDx's claims for patent infringement of United States Patent No. 10,438,271 (entitled "Methods and Systems for Prostate Cancer Prognosis Using Gene Expression Profiling," hereinafter "the '271 Patent"), United States Patent No. 11,204,893 (entitled "Genomic Classifiers for Post-Surgical Risk Stratification of Prostate Cancer," hereinafter "the '893 Patent"), and United States Patent No. 11,891,647 (entitled "Machine-Learning-Based Molecular Classifier for Predicting Prostate Cancer Outcomes," hereinafter "the '647 Patent") (collectively, the "Patents-in-Suit"). These claims arise from Helios's manufacture, use, sale, offer for sale, and/or importation of the ProstaSignal™ Genomic Classifier test (the "Accused Product") in violation of 35 U.S.C. § 271.
GenomeDx requests that Helios produce all responsive documents within thirty (30) days of service of these Requests, or at such other time as may be agreed upon by the parties or ordered by the Court. GenomeDx reserves the right to serve additional requests for production of documents as permitted by the Federal Rules of Civil Procedure and the Local Rules.
Documents designated as confidential by the producing party shall be produced subject to the terms and conditions of the Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 42), which provides for "Confidential" and "Highly Confidential — Attorneys' Eyes Only" designations. Nothing in these Requests shall be construed as a waiver of GenomeDx's right to challenge any confidentiality designation made by Helios under the Stipulated Protective Order.
II. INSTRUCTIONS
A. General Instructions
1. Helios shall produce all responsive documents in its possession, custody, or control. As used herein, "possession, custody, or control" means that Helios has physical possession of the document, has a right to obtain the document from a third party (including any agent, attorney, accountant, consultant, or representative), or has the practical ability to obtain the document from a third party.
2. Without limiting the foregoing, Helios shall produce responsive documents held by its current and former officers, directors, employees, agents, consultants, representatives, attorneys (to the extent not protected by the attorney-client privilege or work-product doctrine), accountants, independent contractors, and any other persons or entities acting or purporting to act on Helios's behalf.
3. Helios shall produce responsive documents held by its parent companies, subsidiaries, affiliates, divisions, and majority investors, to the extent such documents are within Helios's possession, custody, or control. This instruction encompasses, without limitation, documents held by or shared with Corinth Ventures Fund III, LP, its general partner, and any related entities or personnel, including Managing Director Priya Chandrasekaran, to the extent Helios has possession, custody, or control over such documents.
4. Helios shall produce all responsive documents regardless of the medium in which they are stored, whether paper, electronic, audio, video, photographic, or any other form or medium.
5. If any document responsive to these Requests has been destroyed, discarded, lost, overwritten, or is otherwise no longer available, Helios shall: (a) identify the document by type, author, recipient, date, and general subject matter to the best of its knowledge, information, and belief; (b) describe the contents of the document; (c) state the date on or about which the document was destroyed, discarded, lost, or became unavailable; (d) state the reason for the destruction, loss, or unavailability; and (e) identify the person(s) who authorized or carried out the destruction or disposal, or who have knowledge of the circumstances under which the document became unavailable.
6. If Helios objects to any Request, it shall state the objection with specificity, including the legal and factual bases therefor, and shall produce all documents responsive to the non-objectionable portions of the Request. A general or boilerplate objection shall not relieve Helios of its obligation to produce responsive documents.
7. No document shall be withheld or redacted solely on the basis that it contains information both responsive and non-responsive to a particular Request. If a document is responsive in part, it shall be produced in its entirety unless a specific and well-founded privilege or protection applies to the non-responsive portion.
B. Form of Production
1. Helios shall produce ESI in native format or as single-page TIFF images (300 dpi minimum resolution) with accompanying load files containing extracted text (or OCR text for image-only documents) and all associated metadata, consistent with the parties' ESI Protocol agreed upon on November 14, 2025 (Dkt. No. 37).
2. Helios shall produce documents as they are kept in the ordinary course of business, organized by custodian. Each custodian's documents shall be clearly identified and segregated. If documents have been collected from shared drives, databases, or other repositories not associated with a single custodian, such documents shall be organized and labeled by their source.
3. Helios shall produce complete copies of all responsive documents, including all attachments, enclosures, cover letters, and any other documents physically or electronically appended or affixed thereto.
4. For each document withheld in whole or in part on the grounds of attorney-client privilege, work-product protection, or any other privilege or immunity, Helios shall provide a privilege log entry in compliance with Federal Rule of Civil Procedure 26(b)(5)(A) and Local Rule 37-1. Each privilege log entry shall identify, at a minimum: (i) the date of the document or communication; (ii) the author(s) or speaker(s); (iii) all recipient(s) and persons copied; (iv) the general subject matter of the document or communication (described with sufficient specificity to enable GenomeDx and the Court to assess the applicability of the privilege); and (v) the specific privilege(s) or protection(s) asserted.
5. Helios shall produce a privilege log within thirty (30) days of the date of production of documents, or at such other time as ordered by the Court or agreed upon by the parties.
C. Time Period
Unless otherwise specified in a particular Request, each Request covers the period from January 1, 2019 (the year of Helios's founding and incorporation in the State of Delaware) through the date of production. GenomeDx reserves the right to seek supplementation for documents created after the initial production.
D. Continuing Obligation
These Requests for Production are continuing in nature pursuant to Federal Rule of Civil Procedure 26(e). Helios is obligated to supplement its responses and production promptly as additional responsive documents are identified, located, or created, including documents that come into Helios's possession, custody, or control after the initial production.
III. DEFINITIONS
As used in these Requests for Production, the following terms shall have the meanings set forth below:
1. "Helios" or "You" or "Your" means Helios Precision Diagnostics, Inc., a Delaware corporation with its principal place of business at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, including its current and former officers, directors, employees, agents, representatives, consultants, predecessors, successors, subsidiaries, affiliates, divisions, and any person or entity acting or purporting to act on its behalf. Without limiting the generality of the foregoing, "Helios" specifically includes Dr. Nathan Ashford (Chief Executive Officer and Co-Founder), Dr. Elaine Kossack (Chief Science Officer and Co-Founder), Derek Mallinson (Vice President of Commercial Operations), Sara Whitmore (Vice President of Regulatory and Quality), and Dr. Anton Rykov (Director of Bioinformatics).
2. "GenomeDx" means Genome Dx Therapeutics Inc., the Plaintiff in this action, including its officers, directors, employees, agents, representatives, and any person or entity acting or purporting to act on its behalf.
3. "ProstaSignal™" or "Accused Product" means the ProstaSignal™ Genomic Classifier, including all versions, iterations, builds, prototypes, pre-commercial versions, and predecessor products, whether commercially launched or in development, and including the 24-gene expression-based prognostic test for prostate cancer post-radical prostatectomy that was commercially launched on or about October 7, 2024. The term encompasses all aspects of the test, including the gene panel, classifier algorithm, scoring methodology, sample processing protocols, and reporting format.
4. "ProstaScore" means the numerical prognostic score (on a scale of 0 to 100) generated by the ProstaSignal™ Genomic Classifier and the associated risk classifications of Low, Intermediate, or High risk, as reported to ordering physicians and included in clinical reports.
5. "Patents-in-Suit" means United States Patent No. 10,438,271 ("the '271 Patent"), United States Patent No. 11,204,893 ("the '893 Patent"), and United States Patent No. 11,891,647 ("the '647 Patent"), together with any continuations, continuations-in-part, divisionals, reissues, reexaminations, and foreign counterparts thereof.
6. "Decipher®" means GenomeDx's Decipher® Prostate genomic classifier test, including all versions and iterations thereof, and the associated genomic scoring and risk classification methodology.
7. "Document" or "Documents" shall be construed in the broadest sense permitted under Federal Rule of Civil Procedure 34(a) and shall include, without limitation, writings, drawings, graphs, charts, photographs, sound recordings, video recordings, images, data, data compilations, electronically stored information ("ESI"), emails, text messages (including SMS and MMS), instant messages, messages transmitted via Meridian Solutions, Northgate Data Systems, Meridian Services Inc., Signal, or any other messaging platform, presentations, spreadsheets, memoranda, correspondence (whether formal or informal), notes (including handwritten notes), reports, studies, analyses, meeting minutes, agendas, summaries, board materials, financial records, contracts, agreements, invoices, receipts, drafts, and any other tangible or intangible thing from which information can be obtained, whether stored in paper, electronic, magnetic, optical, or any other form.
8. "Communication" or "Communications" means any oral, written, or electronic exchange of information between two or more persons, including but not limited to emails, letters, memoranda, facsimiles, text messages, instant messages, messages transmitted via Meridian Solutions, Northgate Data Systems, or other messaging platforms, video conferences (including recordings or transcripts thereof), telephone calls (including voicemails), and in-person conversations, whether formal or informal.
9. "Relating to" or "Concerning" means referring to, regarding, describing, evidencing, constituting, mentioning, pertaining to, reflecting, connected with, commenting on, in respect of, about, supporting, contradicting, or having any logical connection to the subject matter referenced.
10. "Person" means any natural person, corporation, partnership, limited liability company, joint venture, association, trust, governmental entity, or other legal entity.
11. "Corinth Ventures" means Corinth Ventures Fund III, LP, its general partner (Corinth Ventures Management III, LLC), Managing Director Priya Chandrasekaran, and any related entities, affiliated funds, or personnel.
12. "Aether" means Aether Life Sciences Partners, its general partner, managing members, and any related entities, affiliated funds, or personnel.
13. "MAAA Code" means a Multianalyte Assays with Algorithmic Analyses code assigned under the Centers for Medicare & Medicaid Services' Molecular Diagnostic Services (MolDX) program, used for coverage, coding, and reimbursement of molecular diagnostic tests.
IV. REQUESTS FOR PRODUCTION
Category A: ProstaSignal™ Design, Development, and Technical Documentation
REQUEST FOR PRODUCTION NO. 1:
All Documents Relating to the conception, design, research, and development of the ProstaSignal™ Genomic Classifier, including but not limited to project plans, project charters, timelines, Gantt charts, milestone trackers, research proposals, grant applications, laboratory notebooks, experimental records, bench notes, meeting minutes, meeting agendas, internal presentations, slide decks, progress reports, status updates, technical memoranda, design documents, architecture documents, and any other Documents reflecting the evolution of the ProstaSignal™ test from the inception of the project to the present.
REQUEST FOR PRODUCTION NO. 2:
All Documents Relating to the selection, identification, evaluation, and prioritization of the genes included in the ProstaSignal™ 24-gene expression panel, including but not limited to the scientific rationale and criteria used to select each gene, any analyses comparing candidate gene sets or evaluating the predictive performance of alternative gene panels, any literature reviews or meta-analyses informing gene selection, and any Documents identifying which genes in the ProstaSignal™ panel overlap with, are identical to, or are functionally equivalent to any gene sets disclosed, described, or claimed in the Patents-in-Suit or used in the Decipher® test.
REQUEST FOR PRODUCTION NO. 3:
All Documents Relating to the machine-learning classifier used in the ProstaSignal™ test, including but not limited to Documents describing or reflecting the architecture, design, training methodology, hyperparameter selection, hyperparameter tuning, cross-validation procedures, regularization techniques, feature importance analyses, and implementation of the gradient-boosted decision tree classifier or any other classifier algorithm (including but not limited to random forest, support vector machine, neural network, logistic regression, or ensemble methods) used, tested, evaluated, or considered for use in connection with the ProstaSignal™ test at any stage of its development.
REQUEST FOR PRODUCTION NO. 4:
All training data, validation data, and test data (including holdout sets) used in connection with the development, training, validation, and performance assessment of the ProstaSignal™ classifier, including cohort descriptions, sample sizes, patient demographic information, clinical endpoints used, outcome data, follow-up durations, and any Documentation of data sources, data provenance, data use agreements, material transfer agreements, and Institutional Review Board (IRB) approvals or exemptions associated with the use of such data.
REQUEST FOR PRODUCTION NO. 5:
All Documents Relating to the feature selection methodology employed in developing the ProstaSignal™ classifier, including but not limited to any statistical analyses, feature ranking algorithms, wrapper methods, filter methods, embedded methods, recursive feature elimination analyses, LASSO or elastic net regularization analyses, or other protocols used to identify predictive gene features from candidate gene sets, and any comparisons, mappings, or analyses comparing the selected feature sets with those disclosed, described, or claimed in the Patents-in-Suit.
REQUEST FOR PRODUCTION NO. 6:
All Documents Relating to the RNA extraction protocols, sample processing methods, quality control procedures, and normalization procedures used in the ProstaSignal™ test, including but not limited to protocols for the receipt, accessioning, macrodissection, and processing of formalin-fixed paraffin-embedded (FFPE) prostate tissue samples, RNA isolation and purification methods, RNA quality assessment criteria (including minimum RNA Integrity Number or DV200 thresholds), microarray or sequencing platform specifications, reference gene panels used for normalization, batch correction methods, and any standard operating procedures (SOPs), work instructions, or technical bulletins governing sample processing for the ProstaSignal™ test.
REQUEST FOR PRODUCTION NO. 7:
All Documents Relating to the computation, generation, calibration, and interpretation of the ProstaScore (the numerical prognostic score from 0 to 100 generated by the ProstaSignal™ test), including but not limited to the mathematical or algorithmic formula for calculating the score, the methodology for mapping raw classifier output to the 0–100 scale, the methodology for classifying patients into Low, Intermediate, or High risk categories, the thresholds or cut-points used for each risk category, any validation of the thresholds against clinical outcomes, and any Documents reflecting changes or revisions to the scoring methodology or risk thresholds over time.
REQUEST FOR PRODUCTION NO. 8:
All Documents Relating to the integration, combination, or co-presentation of the ProstaScore with clinical covariates, including but not limited to Gleason score (or Gleason grade group), prostate-specific antigen (PSA) level, surgical margin status, extraprostatic extension, seminal vesicle invasion, lymph node involvement, and/or pathological stage, and any Documents Relating to the generation of a composite, combined, or integrated prognostic report that incorporates both genomic data from the ProstaSignal™ test and clinical or pathological data, including the design of any nomograms, risk calculators, or decision-support tools incorporating ProstaScore results.
REQUEST FOR PRODUCTION NO. 9:
All Documents Relating to any alternative classifier algorithms, gene panels, scoring methodologies, test designs, sample processing methods, or reporting formats that Helios considered, designed, developed, tested, evaluated, or implemented as alternatives to the ProstaSignal™ test as commercially launched, including but not limited to any "design-around" analyses, feasibility studies, or technical assessments conducted to evaluate whether alternative approaches could achieve comparable clinical performance while avoiding the scope of the Patents-in-Suit, and any Documents reflecting the reasons for selecting or rejecting any such alternatives.
REQUEST FOR PRODUCTION NO. 10:
All Documents Relating to the persons involved in the conception, design, development, validation, implementation, commercialization, and ongoing operation of the ProstaSignal™ test, including but not limited to organizational charts, team rosters, role descriptions, job descriptions, project assignment records, and any Documents identifying each individual's specific contributions to the ProstaSignal™ project, specifically including Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, and any other scientists, bioinformaticians, statisticians, software engineers, or other technical personnel who contributed to the design or development of the classifier algorithm, gene panel, or scoring methodology.
Category B: Clinical Validation and Regulatory
REQUEST FOR PRODUCTION NO. 11:
All Documents Relating to clinical validation studies of the ProstaSignal™ test, including but not limited to study protocols, statistical analysis plans, patient cohort descriptions, informed consent forms, case report forms, analytical validation data (including accuracy, precision, reproducibility, and limit-of-detection analyses), clinical utility analyses (including decision-impact studies and health economic analyses), clinical validity analyses, study results and conclusions, manuscripts (both published and unpublished, including all drafts), posters, abstracts, regulatory submissions, and any correspondence with journal editors, peer reviewers, or collaborating institutions relating to such studies.
REQUEST FOR PRODUCTION NO. 12:
All Documents Relating to Helios's application for, receipt of, and ongoing compliance with MAAA Code 0239M for the ProstaSignal™ test from the Molecular Diagnostic Services (MolDX) program administered by Palmetto GBA or any other Medicare Administrative Contractor (MAC), including but not limited to the initial application and all supporting documentation, any technical assessment dossiers submitted, all correspondence with MolDX, Palmetto GBA, or any MAC, coverage determination requests, Local Coverage Determinations (LCDs) or Local Coverage Articles (LCAs) applicable to ProstaSignal™, any appeal or reconsideration requests, and any post-coverage monitoring or compliance documentation.
REQUEST FOR PRODUCTION NO. 13:
All Documents Relating to Helios's Clinical Laboratory Improvement Amendments (CLIA) certification for its laboratory located at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, including but not limited to the CLIA certificate (including the certificate number and effective dates), all inspection reports from the Centers for Medicare & Medicaid Services (CMS) or its agents, proficiency testing results, corrective action plans, any deficiency notices or citations, and any correspondence with CMS, state regulatory bodies, or accreditation organizations (including the College of American Pathologists, if applicable) Concerning the ProstaSignal™ test or Helios's laboratory operations.
REQUEST FOR PRODUCTION NO. 14:
All Documents Relating to the design, development, and validation of the ProstaSignal™ classifier algorithm, including but not limited to all training data, feature selection methodology, model architecture, model versioning, software code (including source code and executable code for the classifier), algorithm specifications, performance metrics (including area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, negative predictive value, and concordance index), and any internal or external validation results. GenomeDx notes that this Request was the subject of a trade-secret objection raised by Helios, which was resolved through the parties' meet-and-confer conference conducted on December 5, 2025, and the entry of the Stipulated Protective Order on December 18, 2025 (Dkt. No. 42). Helios has agreed to produce responsive documents to this Request subject to the "Highly Confidential — Attorneys' Eyes Only" designation under the Protective Order.
REQUEST FOR PRODUCTION NO. 15:
All Documents Relating to any submission to, pre-submission meeting with, or regulatory strategy concerning the United States Food and Drug Administration (FDA) for or regarding the ProstaSignal™ test, including but not limited to any pre-submission (Q-Sub) requests, meeting minutes, FDA feedback letters, 510(k) premarket notifications, de novo classification requests, premarket approval (PMA) applications, regulatory strategy memoranda, and any internal assessment or analysis of whether the ProstaSignal™ test is subject to FDA regulation as a laboratory-developed test (LDT), an in vitro diagnostic (IVD) device, or otherwise, including any analysis of the impact of the FDA's final rule regarding LDTs published in 2024.
Category C: Awareness of GenomeDx Patents and Freedom-to-Operate
REQUEST FOR PRODUCTION NO. 16:
All Documents Relating to Helios's awareness, knowledge, or analysis of the Patents-in-Suit (U.S. Patent Nos. 10,438,271; 11,204,893; and 11,891,647), including but not limited to any Communications, memoranda, presentations, analyses, reports, annotated copies of the patents or their claims, claim charts, or other Documents discussing, referencing, or analyzing these patents, their claims, their specifications, their prosecution histories, or their relevance to the ProstaSignal™ test or any other Helios product or technology.
REQUEST FOR PRODUCTION NO. 17:
All Documents Relating to any freedom-to-operate analysis, patent clearance study, patent landscape analysis, non-infringement opinion, invalidity opinion, unenforceability opinion, or similar analysis conducted by or for Helios (whether by in-house counsel, outside counsel, patent agents, consultants, or any other Person) with respect to the Patents-in-Suit, any other patent owned or controlled by GenomeDx, or any other third-party patent Relating to genomic prostate cancer diagnostics, prognostic classifiers, or gene expression profiling methods.
REQUEST FOR PRODUCTION NO. 18:
All Documents Relating to any opinion of counsel obtained by Helios regarding the Patents-in-Suit, including but not limited to opinions on infringement, non-infringement, validity, invalidity, enforceability, or unenforceability, to the extent Helios has asserted or intends to assert an advice-of-counsel defense or a defense of good-faith reliance on the opinion of counsel. If Helios does not intend to assert any such defense and does not intend to rely on any opinion of counsel in this litigation, a written statement to that effect shall suffice in response to this Request.
REQUEST FOR PRODUCTION NO. 19:
All Documents Relating to any analysis, review, monitoring, or consideration by Helios of GenomeDx's patent portfolio beyond the Patents-in-Suit, including but not limited to any analysis of the forty-seven (47) issued United States patents, twelve (12) pending United States patent applications, and nineteen (19) international family members owned or controlled by GenomeDx, and any assessment of whether any such patents or applications are relevant to the ProstaSignal™ test or any other Helios product, technology, or research program.
REQUEST FOR PRODUCTION NO. 20:
All Documents Relating to any Communications between Helios (including any of its officers, directors, employees, or agents) and its investors, including but not limited to Corinth Ventures Fund III, LP, Aether Life Sciences Partners, and any other current or former investors, Concerning GenomeDx's patents (including the Patents-in-Suit), the Decipher® test, GenomeDx as a competitor, or any intellectual property risks, patent infringement risks, or litigation risks associated with the ProstaSignal™ test.
REQUEST FOR PRODUCTION NO. 21:
All Documents Relating to any due diligence conducted by or on behalf of Helios, Corinth Ventures Fund III, LP, Aether Life Sciences Partners, or any other investor or potential investor in Helios, regarding GenomeDx's intellectual property, including but not limited to the Patents-in-Suit, GenomeDx's broader patent portfolio, GenomeDx's trade secrets, and any competitive or freedom-to-operate risks posed by GenomeDx's intellectual property, including all due diligence reports, memoranda, questionnaires, data room materials, correspondence, and presentations prepared or exchanged in connection with such due diligence.
Category D: Business Plans, Board Materials, and Investor Presentations
REQUEST FOR PRODUCTION NO. 22:
All pre-launch business plans, business strategy documents, strategic planning materials, market entry analyses, and go-to-market planning materials Relating to the ProstaSignal™ test, including but not limited to any Documents referencing GenomeDx, the Decipher® test, the Patents-in-Suit, competitive positioning vis-à-vis GenomeDx or any other competitor, market opportunity assessments, target market analyses, or commercialization strategies. GenomeDx notes that this Request is the subject of Plaintiff's Motion to Compel Production of Pre-Launch Business Plans and Board Materials, filed January 30, 2026 (Dkt. No. 58).
REQUEST FOR PRODUCTION NO. 23:
All board of directors presentations, board minutes, board resolutions, board packages, written consents, and materials provided to or prepared for Helios's board of directors (including any board observers) Relating to the ProstaSignal™ test, its design, development, launch, commercialization, competitive positioning, intellectual property strategy, intellectual property risks, and/or containing any references to GenomeDx, the Decipher® test, or the Patents-in-Suit. GenomeDx notes that this Request is the subject of Plaintiff's Motion to Compel Production of Pre-Launch Business Plans and Board Materials, filed January 30, 2026 (Dkt. No. 58).
REQUEST FOR PRODUCTION NO. 24:
All Documents provided to, shared with, or prepared for Helios's investors (including but not limited to Corinth Ventures Fund III, LP, Aether Life Sciences Partners, and any other current or former equity investors, debt holders, or strategic partners) Relating to the ProstaSignal™ test, including but not limited to investor updates, quarterly reports, annual reports, pitch decks, fundraising presentations, private placement memoranda, confidential information memoranda, product roadmaps, milestone updates, and any other investor communications.
REQUEST FOR PRODUCTION NO. 25:
All Documents Relating to any valuation analysis of Helios or the ProstaSignal™ test prepared by or for Helios, its board of directors, its investors, or any third-party appraiser or financial advisor, including but not limited to financial models, revenue projections, discounted cash flow analyses, comparable company analyses, comparable transaction analyses, 409A valuations, fairness opinions, and any assumptions, inputs, or scenarios underlying such valuations.
REQUEST FOR PRODUCTION NO. 26:
All Documents Relating to Helios's corporate governance, including but not limited to its certificate of incorporation (and any amendments thereto), bylaws (and any amendments thereto), stockholders' agreements, investor rights agreements, voting agreements, right of first refusal and co-sale agreements, board observation rights agreements, management rights letters, and any other governance documents entered into with Corinth Ventures Fund III, LP, Aether Life Sciences Partners, or any other investor, stockholder, or stakeholder.
Category E: Commercial Launch, Marketing, and Sales
REQUEST FOR PRODUCTION NO. 27:
All Documents Relating to the commercial launch of the ProstaSignal™ test on or about October 7, 2024, including but not limited to launch plans, launch checklists, launch timelines, marketing plans, marketing budgets, go-to-market strategies, sales force deployment plans, key account strategies, territory assignment plans, post-launch assessments, post-launch review reports, lessons-learned analyses, and any Communications with key opinion leaders, early adopters, or strategic accounts in connection with the launch.
REQUEST FOR PRODUCTION NO. 28:
All marketing, promotional, advertising, and sales materials for the ProstaSignal™ test, including but not limited to brochures, product sheets, fact sheets, frequently asked questions (FAQ) documents, website content (including screenshots or archived versions of helioprecision.com or any related web properties), social media posts (including posts on Westmark Health IT, Westvale Solutions, Kestrel Services Inc., Northpoint Services Inc., and any other platform), press releases, conference presentations, poster presentations, exhibit booth materials, white papers, technical briefs, case studies, clinical vignettes, patient education materials, and materials provided to or intended for physicians, urologists, oncologists, pathologists, hospitals, pathology laboratories, health systems, or payers.
REQUEST FOR PRODUCTION NO. 29:
All Documents Relating to the pricing, reimbursement strategy, and payer contracting for the ProstaSignal™ test, including but not limited to any analyses of reimbursement rates (including the average reimbursement of approximately $3,820 per test), Medicare reimbursement schedules, fee schedules, payer coverage determinations (both favorable and adverse), payer engagement plans, payer contract templates, executed payer contracts, negotiations with commercial insurers, negotiations with government payers (including Medicare and Medicaid), any health technology assessments, and any economic analyses or budget impact models prepared in connection with payer discussions.
REQUEST FOR PRODUCTION NO. 30:
All Documents Relating to Helios's competitive analysis of the Decipher® test or any other competing genomic prostate cancer prognostic test (including, without limitation, Prolaris®, Oncotype DX Genomic Prostate Score®, and any other commercially available or developmental tests), including but not limited to market share analyses, competitive intelligence reports, SWOT analyses, battlecard documents, competitive positioning statements, head-to-head comparison materials, and any analyses of the clinical performance, pricing, reimbursement, or market penetration of competing tests.
REQUEST FOR PRODUCTION NO. 31:
All investor materials, board presentations, internal reports, management reports, or executive summaries discussing GenomeDx, the Decipher® test, GenomeDx's market share, GenomeDx's commercial performance, or the competitive landscape for genomic prostate cancer prognostic testing, including any analyses of how the ProstaSignal™ test is positioned relative to the Decipher® test or any other competitor. GenomeDx notes that this Request is the subject of Plaintiff's Motion to Compel Production of Pre-Launch Business Plans and Board Materials, filed January 30, 2026 (Dkt. No. 58).
REQUEST FOR PRODUCTION NO. 32:
All Documents Relating to the number of ProstaSignal™ tests performed, ordered, accessioned, reported, billed, or reimbursed during each calendar month from October 2024 through the date of production, including but not limited to test volume reports, revenue reports, reimbursement data (broken down by payer type, including Medicare, Medicaid, commercial payers, self-pay, and other categories), accounts receivable aging reports, and any internal dashboards, trackers, or management reports reflecting test volumes, revenue, or reimbursement trends.
REQUEST FOR PRODUCTION NO. 33:
All Documents Relating to customer or client acquisition for the ProstaSignal™ test, including but not limited to lists of ordering physicians, ordering institutions, hospitals, pathology groups, urology practices, or oncology practices, sales call reports, customer relationship management (CRM) records, account plans, and any Communications with healthcare providers in which the ProstaSignal™ test is compared, contrasted, or discussed in relation to the Decipher® test or any other competing genomic prostate cancer diagnostic test.
Category F: Financial Documents
REQUEST FOR PRODUCTION NO. 34:
Helios's audited and unaudited financial statements (including income statements, balance sheets, statements of cash flows, statements of stockholders' equity, and all accompanying notes, schedules, and supplementary information) for fiscal years 2019, 2020, 2021, 2022, 2023, 2024, and 2025 (to the extent available as of the date of production), including but not limited to FY 2024 financial statements reflecting reported revenue of approximately $71.2 million, and any management letters, audit reports, or communications from Helios's independent auditors.
REQUEST FOR PRODUCTION NO. 35:
All Documents Relating to revenues, costs, and profits (or losses) attributable to the ProstaSignal™ test, including but not limited to revenue breakdowns by payer type (Medicare, Medicaid, commercial, self-pay, and other), cost of goods sold (COGS), direct costs (including reagent costs, labor costs, sample processing costs, and shipping costs), variable costs, fixed costs allocable to the ProstaSignal™ product line, gross margins, contribution margins, operating margins, and any internal cost accounting or product-line profitability analyses for the ProstaSignal™ test.
REQUEST FOR PRODUCTION NO. 36:
All Documents Relating to Helios's financial projections, budgets, operating plans, and forecasts for the ProstaSignal™ test, including but not limited to projected test volumes, revenue forecasts, profitability projections, and scenario analyses for fiscal years 2024, 2025, and any subsequent periods, as well as long-range financial plans or five-year financial models incorporating the ProstaSignal™ test.
REQUEST FOR PRODUCTION NO. 37:
All Documents Relating to funding rounds, capital raises, debt financings, or other financing transactions involving Helios, including but not limited to term sheets, letters of intent, subscription agreements, stock purchase agreements, convertible note agreements, SAFE agreements, loan agreements, credit facilities, and any documents in which the ProstaSignal™ test, GenomeDx's intellectual property, the Patents-in-Suit, or patent infringement risks are discussed, referenced, or analyzed in connection with fundraising, due diligence, or investment decision-making.
REQUEST FOR PRODUCTION NO. 38:
All Documents Relating to Helios's overall corporate revenue, costs, expenses, and profitability, broken down by product line, business segment, or revenue stream, for fiscal years 2022 through 2025 (to the extent available as of the date of production), including any internal management reports, segment reporting analyses, or product-line financial summaries prepared for management, the board of directors, or investors.
Category G: Prior Art and Invalidity Contentions
REQUEST FOR PRODUCTION NO. 39:
All Documents Relating to Helios's invalidity contentions or defenses with respect to the Patents-in-Suit, including but not limited to any prior art search reports, prior art analyses, claim-by-claim invalidity analyses, anticipation charts, obviousness analyses, or Documents identifying, analyzing, or evaluating prior art references, including but not limited to Nakamura et al. (U.S. Patent No. 9,617,340), Gagnon (International Publication No. WO 2018/065413), Thornberry et al. ("Gradient-Boosted Ensemble Methods for Multi-Gene Prognostic Classification in Solid Tumors," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301, March 2015), Klein et al. ("A Genomic Classifier Improves Prediction of Metastatic Disease Within 5 Years After Surgery in Node-Negative High-Risk Prostate Cancer Patients Managed by Radical Prostatectomy Without Adjuvant Therapy," European Urology, Vol. 66, No. 1, pp. 45–52, 2014), and any other prior art references identified or relied upon by Helios.
REQUEST FOR PRODUCTION NO. 40:
All Documents Relating to any analysis conducted by or for Helios of the prosecution histories of the Patents-in-Suit before the United States Patent and Trademark Office (USPTO), including but not limited to any analyses of the amendments made to the claims during prosecution, the arguments presented to the examiner, any statements or representations made by GenomeDx or its patent counsel during prosecution, any office actions or rejections, and any assessment of prosecution history estoppel or the impact of the prosecution history on claim scope or infringement analysis.
REQUEST FOR PRODUCTION NO. 41:
All Documents Relating to Helios's contention or defense that its scientists independently developed the ProstaSignal™ classifier beginning in or about 2020, based on publicly available gene-expression datasets, including but not limited to the identification of all such publicly available datasets (by name, accession number, repository, and URL), the dates on which each dataset was accessed or downloaded, all analyses, code, scripts, notebooks, and computational workflows performed using such datasets, and any Documents reflecting the chain of development from publicly available data to the commercially launched ProstaSignal™ test.
REQUEST FOR PRODUCTION NO. 42:
All Documents Relating to any scientific publications, peer-reviewed journal articles, conference presentations (oral or poster), abstracts, preprints, white papers, or other public disclosures by Helios or any of its current or former officers, directors, employees, consultants, or scientific advisors Concerning the ProstaSignal™ test, the underlying technology, the gene panel, the classifier algorithm, or any related research, including all drafts, submission records, editorial correspondence, peer review comments, author responses, and proofs.
Category H: Licensing and Third-Party Agreements
REQUEST FOR PRODUCTION NO. 43:
All Documents Relating to any license agreement, technology transfer agreement, collaboration agreement, joint development agreement, sponsored research agreement, or material transfer agreement between Helios and any third party Concerning genomic prostate cancer diagnostics, prognostic classifiers, gene expression profiling methods, machine-learning-based diagnostic methods, or any technology Relating to the subject matter of the Patents-in-Suit, including the agreement itself, all amendments, all schedules and exhibits, and any correspondence, reports, or deliverables exchanged thereunder.
REQUEST FOR PRODUCTION NO. 44:
All Documents Relating to any Communication or negotiation between Helios (including any of its officers, directors, employees, agents, or counsel) and GenomeDx (including any of its officers, directors, employees, agents, or counsel), including but not limited to any licensing discussions or proposals, cease-and-desist letters, demand letters, invitation-to-license letters, or other pre-litigation Communications Concerning the Patents-in-Suit, the ProstaSignal™ test, the Decipher® test, or any intellectual property dispute between the parties.
REQUEST FOR PRODUCTION NO. 45:
All Documents Relating to Helios's awareness of, analysis of, or response to the non-exclusive license agreement between GenomeDx and Veridian Molecular Labs, Inc. dated April 3, 2022, or any other license granted by GenomeDx under the Patents-in-Suit or related patents to any third party, including any assessment of the terms, scope, royalty rates, or other commercial terms of such license(s) and any consideration of whether such license(s) are relevant to damages, reasonable royalty, or willing-licensor/willing-licensee analyses in this action.
Category I: Personnel and Organizational
REQUEST FOR PRODUCTION NO. 46:
All organizational charts for Helios from January 1, 2019 through the present, and all Documents identifying the personnel involved in the conception, design, development, validation, regulatory approval, commercialization, marketing, and sale of the ProstaSignal™ test, including but not limited to employment agreements, offer letters, consulting agreements, independent contractor agreements, non-disclosure agreements (NDAs), confidentiality agreements, non-competition agreements, non-solicitation agreements, intellectual property assignment agreements, and invention assignment agreements for key personnel, specifically including Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, Derek Mallinson, Sara Whitmore, and any other individual who played a material role in the design, development, or commercialization of the ProstaSignal™ test.
REQUEST FOR PRODUCTION NO. 47:
All Documents Relating to any prior employment, consulting relationship, advisory relationship, or other professional affiliation between any current or former Helios employee, officer, director, consultant, or scientific advisor and GenomeDx, including but not limited to any analysis, investigation, or assessment of whether any such individual had access to, knowledge of, or exposure to GenomeDx's trade secrets, proprietary information, confidential technical data, unpublished research, or know-how Relating to the Decipher® test, the Patents-in-Suit, or any technology within the scope of the Patents-in-Suit, and any steps taken by Helios to screen, quarantine, or otherwise prevent the use of any such confidential information in the development of the ProstaSignal™ test.
V. SIGNATURE
Dated: January 27, 2026
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Catherine Bloom (CA Bar No. 247189) Responsible Partner
Peter Vassiliev (CA Bar No. 312054) Lead Associate
CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-6200 Facsimile: (415) 773-6201
Email: cbloom@calderwoodharkness.com
Email: pvassiliev@calderwoodharkness.com
Attorneys for Plaintiff Genome Dx Therapeutics Inc.
CERTIFICATE OF SERVICE
I, Catherine Bloom, hereby certify that on January 27, 2026, I caused a true and correct copy of the foregoing PLAINTIFF GENOME DX THERAPEUTICS INC.'S FIRST SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC. (Nos. 1–47) to be served upon counsel for Defendant Helios Precision Diagnostics, Inc. via electronic mail and the Court's Electronic Case Filing (ECF) system, addressed as follows:
Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 542-8800
Email: mpellegrini@ridgecrestkirkpatrick.com
Email: dforrest@ridgecrestkirkpatrick.com
Email: ochu@ridgecrestkirkpatrick.com
and
RIDGECREST DURNEVAL LLP 350 South Grand Avenue, Suite 2800 Los Angeles, California 90071
Attorneys for Defendant Helios Precision Diagnostics, Inc.
By: ________
Catherine Bloom
GENOME DX THERAPEUTICS INC., | Case No. 3:25-cv-01847-JWL
Plaintiff, | Hon. Jessica W. Langston
v. | Magistrate Judge Hon. David R. Cabrera
HELIOS PRECISION DIAGNOSTICS, INC.,
Defendant.

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA

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V. SIGNATURE

CALDERWOOD & HARKNESS LLP

CERTIFICATE OF SERVICE

HELIOS PRECISION DIAGNOSTICS, INC.,

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