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

30b6-deposition-notice-helios.docx DOCUMENT Litigation

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UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

PLAINTIFF'S NOTICE OF RULE 30(b)(6) DEPOSITION OF DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC.

TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:

PLEASE TAKE NOTICE that, pursuant to Federal Rules of Civil Procedure 30(b)(1) and 30(b)(6), and the Scheduling Order entered June 18, 2025 by the Honorable Jessica W. Langston, Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") hereby notices the deposition upon oral examination of Defendant Helios Precision Diagnostics, Inc. ("Helios") by one or more officers, directors, managing agents, or other persons designated by Helios to testify on its behalf regarding the matters described in reasonable particularity in Exhibit A attached hereto and incorporated herein by reference. This Notice is served on February 28, 2026. Fact discovery in this matter closes on March 6, 2026, pursuant to the Scheduling Order entered June 18, 2025. Helios is required to designate and produce one or more witnesses who are prepared to testify fully and non-evasively on each of the fourteen (14) topics set forth in Exhibit A.

I. DEPOSITION LOGISTICS

A. Date and Time

The deposition noticed herein shall commence on a date and time to be agreed upon by the parties no later than the fact discovery close date of March 6, 2026, or as otherwise ordered by the Court. GenomeDx's counsel will confer with Helios's counsel in good faith to identify mutually agreeable dates within the remaining fact discovery period. In the event the parties are unable to agree upon a date within five (5) business days of service of this Notice, GenomeDx reserves the right to seek relief from Magistrate Judge David R. Cabrera, including an order setting the deposition date. Proposed dates shall be determined by agreement of counsel and communicated in writing. The deposition shall begin at 9:30 a.m. Pacific Time and shall continue day-to-day until completed.

B. Location. The deposition shall take place at the offices of Calderwood & Harkness LLP, located at 555 Mission Street, Suite 3100, San Francisco, California 94105, or at such other location as the parties may agree upon in writing, including the offices of Ridgecrest Durneval LLP, located at 350 South Grand Avenue, Suite 2800, Los Angeles, California 90071. In the alternative, the deposition may be conducted by remote means via contemporaneous video transmission if the parties so agree in writing or if the Court so orders.

C. Recording Method

The deposition will be recorded by stenographic means before a certified court reporter and simultaneously by videography pursuant to Federal Rule of Civil Procedure 30(b)(3)(A). GenomeDx reserves the right to record the deposition by additional means permitted under Rule 30(b)(3), including but not limited to audio recording. GenomeDx will bear the initial costs of the stenographic recording and videography. All original transcripts and recordings shall be maintained in accordance with the Stipulated Protective Order entered December 18, 2025.

D. Counsel. Plaintiff GenomeDx will be represented at the deposition by the following counsel:

Catherine Bloom (California Bar No. 198472) Peter Vassiliev (California Bar No. 287613) Wendy Schultz (California Bar No. 304851) CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-5600 Facsimile: (415) 773-5601

Email: cbloom@calderwoodharkness.com

Email: pvassiliev@calderwoodharkness.com

Email: wschultz@calderwoodharkness.com

Defendant Helios is represented by the following counsel of record:

Marcus Pellegrini (California Bar No. 221094; Massachusetts Bar No. 682415) Danielle Forrest (California Bar No. 256738) Owen Chu (California Bar No. 311209) RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 426-8300 Facsimile: (617) 426-8301

and

350 South Grand Avenue, Suite 2800 Los Angeles, California 90071 Telephone: (213) 892-4500 Facsimile: (213) 892-4501

Email: mpellegrini@ridgecrestkirkpatrick.com

Email: dforrest@ridgecrestkirkpatrick.com

Email: ochu@ridgecrestkirkpatrick.com

II. DESIGNATION OF CORPORATE REPRESENTATIVE(S)

Pursuant to Federal Rule of Civil Procedure 30(b)(6), Helios is required to designate one or more persons to testify on its behalf regarding each of the topics described with reasonable particularity in Exhibit A. The persons so designated need not be officers or directors of Helios but must be persons who consent to testify on Helios's behalf and who are prepared to testify fully and completely regarding each topic for which they are designated. Helios's obligation under Rule 30(b)(6) is not limited to designating persons with pre-existing personal knowledge of the noticed topics. Rather, Helios bears an affirmative duty to prepare its designees by having them review all relevant documents and materials, consult with current and former employees, officers, directors, and agents who possess knowledge of the noticed topics, and educate themselves so that they can provide complete, knowledgeable, and binding testimony on behalf of the corporation.

GenomeDx requests that Helios identify its designated witness or witnesses no later than ten (10) calendar days prior to the scheduled deposition date. Such identification shall be provided in writing to GenomeDx's counsel and shall include the following information for each designated witness: (a) the witness's full legal name; (b) the witness's current title and position with Helios; and (c) the specific Exhibit A topics as to which each witness will testify. If Helios designates more than one witness, it shall clearly identify the topics allocated to each witness so that the deposition may proceed in an orderly manner.

GenomeDx reserves the right to depose individual fact witnesses separately and in their individual capacities, including without limitation Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), Derek Mallinson (Vice President, Commercial Operations), Sara Whitmore (General Counsel), and Dr. Anton Rykov (Senior Scientist, Bioinformatics). Nothing in this Notice shall be construed as a waiver of GenomeDx's right to notice such individual depositions, nor shall the designation of any of these individuals as a Rule 30(b)(6) witness preclude GenomeDx from deposing them in their individual capacities.

III. DOCUMENT PRODUCTION REQUEST

Pursuant to Federal Rule of Civil Procedure 30(b)(2), GenomeDx hereby requests that Helios produce at the deposition all non-privileged documents, communications, and electronically stored information ("ESI") within Helios's possession, custody, or control that relate to each of the fourteen (14) topics set forth in Exhibit A, to the extent such documents have not already been produced in response to Plaintiff's First Set of Requests for Production of Documents (Nos. 1–47), served on January 27, 2026. This request encompasses documents in any format, including but not limited to paper records, electronic files, emails, text messages, instant messages, Meridian Solutions or Teams messages, presentations, spreadsheets, memoranda, reports, handwritten notes, and voicemail recordings.

All documents produced in connection with this Notice shall be produced in accordance with, and shall be subject to, the Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 47), including the "Confidential" and "Highly Confidential — Attorneys' Eyes Only" designation categories set forth therein. Helios shall designate the confidentiality level of each document at the time of production, consistent with the terms of the Stipulated Protective Order.

To the extent Helios withholds any responsive documents on the basis of attorney-client privilege, the work product doctrine, or any other privilege or protection, Helios shall provide a privilege log identifying each such document with sufficient particularity to permit GenomeDx to assess the claim of privilege, consistent with Federal Rule of Civil Procedure 26(b)(5)(A) and the requirements set forth in the Court's Standing Order on discovery.

IV. DEFINITIONS AND INSTRUCTIONS

A. Definitions. As used in this Notice and in Exhibit A attached hereto, the following terms shall have the meanings ascribed below:

1. "Helios" means Defendant Helios Precision Diagnostics, Inc., a Delaware corporation, including its officers, directors, employees, agents, representatives, subsidiaries, affiliates, predecessors, successors, and any person acting or purporting to act on its behalf.

2. "ProstaSignal™" or "ProstaSignal™ Genomic Classifier" means Helios's 24-gene expression-based prognostic test for prostate cancer post-radical prostatectomy, commercially launched on or about October 7, 2024, and marketed under Molecular Analysis for Therapy Choice (MAAA) code 0239M, including all versions, iterations, and modifications thereof.

3. "GenomeDx" means Plaintiff Genome Dx Therapeutics Inc., a Delaware corporation.

4. "Decipher®" means GenomeDx's proprietary 22-gene genomic classifier test for prostate cancer prognosis, marketed under MAAA code 0047M.

5. "Patents-in-Suit" means, collectively, (a) U.S. Patent No. 10,438,271 (entitled "Gene Expression Profiles for Predicting Prostate Cancer Outcomes," filed June 14, 2016, issued October 8, 2019) ("the '271 Patent"); (b) U.S. Patent No. 11,204,893 (entitled "Genomic Classifiers for Prognosing Post-Surgical Cancer Recurrence," filed March 22, 2019, issued December 21, 2021) ("the '893 Patent"); and (c) U.S. Patent No. 11,891,647 (entitled "Systems and Methods for Integrated Genomic and Clinical Risk Stratification," filed September 9, 2021, issued February 6, 2024) ("the '647 Patent"). Any reference to an individual patent by its short-form designation (e.g., "the '271 Patent") refers to the corresponding patent as identified herein.

6. "Document" shall have the broadest meaning permitted under Federal Rule of Civil Procedure 34(a) and includes all writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations—stored in any medium from which information can be obtained—including electronically stored information ("ESI") such as emails, text messages, instant messages, Meridian Solutions and Northgate Data Systems messages, voicemails, spreadsheets, databases, presentations, source code, and metadata.

7. "Communication" means any oral, written, or electronic exchange, transfer, or dissemination of information between two or more persons, including but not limited to conversations, meetings, telephone calls, video conferences, letters, memoranda, emails, text messages, instant messages, and social media posts.

8. "Relating to" means referring to, concerning, discussing, describing, reflecting, evidencing, constituting, mentioning, pertaining to, or having any connection with, in whole or in part, directly or indirectly.

9. "You" or "Your" means Helios, as defined above.

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

11. "Corinth Ventures" means Corinth Ventures Fund III, LP, a Delaware limited partnership, including its general partner, managing members, investment professionals, and any person acting on its behalf.

12. "Aether" means Aether Life Sciences Partners, including its general partner, managing members, investment professionals, and any person acting on its behalf.

B. Instructions.

1. The designee or designees produced by Helios must be prepared to testify regarding Helios's knowledge, information, and belief as a corporate entity, not merely the designee's own personal knowledge. The testimony of a Rule 30(b)(6) designee binds the corporation to the same extent as an answer to an interrogatory or a request for admission.

2. Helios is obligated to prepare its designated witnesses thoroughly and in good faith by, among other things, reviewing all relevant documents and ESI (whether or not produced in discovery), consulting with current and former employees, officers, directors, and agents who possess knowledge of the noticed topics, reviewing deposition transcripts and declarations in this matter, and taking all other reasonable steps necessary to ensure that each designee can provide full, complete, and non-evasive testimony regarding each topic for which that designee is designated.

3. The deposition will be conducted in accordance with the Federal Rules of Civil Procedure, including Rules 30, 32, and 37, and the Local Rules for the United States District Court for the Northern District of California, including Civil Local Rules 30-1 through 30-3.

4. The Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 47) shall govern the handling, use, and dissemination of all confidential information disclosed during the deposition. Any testimony designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" shall be handled in accordance with the procedures set forth in the Stipulated Protective Order.

5. Unless otherwise agreed by the parties or ordered by the Court, the deposition shall be subject to the seven-hour time limitation prescribed by Federal Rule of Civil Procedure 30(d)(1). GenomeDx reserves the right to seek additional time if warranted by the number of topics, the number of designees, or other circumstances.

EXHIBIT A

TOPICS FOR EXAMINATION PURSUANT TO RULE 30(b)(6)

Helios Precision Diagnostics, Inc. is required to designate one or more persons to testify on its behalf with respect to each of the following topics:

Topic 1: Corporate Organization and Structure

Helios's corporate organization, structure, and governance, including without limitation: (a) the founding and formation of Helios in 2019, its state of incorporation (Delaware), and its qualifications to do business in other states, including the Commonwealth of Massachusetts and the State of California; (b) Helios's principal place of business at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140, and its CLIA-certified laboratory located at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121; (c) Helios's corporate officers, directors, and key personnel, including Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), Derek Mallinson (Vice President, Commercial Operations), Sara Whitmore (General Counsel), and Dr. Anton Rykov (Senior Scientist, Bioinformatics), and the responsibilities and reporting relationships of each; (d) Helios's ownership and equity structure, including the ownership interests of Corinth Ventures Fund III, LP (approximately 58.7%), founders (approximately 22.3%), Aether Life Sciences Partners (approximately 11.0%), and the employee equity pool (approximately 8.0%); and (e) Helios's board composition, governance documents (including certificate of incorporation, bylaws, stockholders' agreements, and voting agreements), and investor rights agreements.

Topic 2: Conception, Design, and Development of ProstaSignal™ Genomic Classifier

The conception, design, development, and creation of the ProstaSignal™ Genomic Classifier, including without limitation: (a) the complete timeline of events from initial conception of the ProstaSignal™ concept through its commercial launch on October 7, 2024, including all significant milestones, decision points, and inflection points in the development process; (b) the respective roles and contributions of Dr. Nathan Ashford (who conceived the ProstaSignal™ concept), Dr. Elaine Kossack (who led the development effort), and Dr. Anton Rykov (who developed the algorithmic classifier) in the design and development process, as well as the roles and contributions of all other Helios personnel involved in the development of ProstaSignal™; (c) all internal project milestones, decision gates, design reviews, project plans, timelines, and status reports relating to the development of ProstaSignal™; and (d) the relationship, if any, between the development of ProstaSignal™ and publicly available gene-expression datasets, published literature, or third-party intellectual property, including Helios's contention that its scientists independently developed the ProstaSignal™ classifier beginning in 2020 without reference to or reliance upon GenomeDx's proprietary technology or patents.

Topic 3: Gene Selection Methodology for ProstaSignal™

The process, methodology, and scientific rationale underlying the selection of the genes included in the ProstaSignal™ Genomic Classifier panel, including without limitation: (a) the complete process by which the 24-gene expression panel used in ProstaSignal™ was identified, evaluated, and ultimately selected; (b) the identification of each of the 24 genes in the ProstaSignal™ panel and the specific scientific rationale for the inclusion of each gene; (c) the extent to which 19 of the 24 ProstaSignal™ genes overlap with genes included in GenomeDx's patented gene set, and any analysis, discussion, or awareness of such overlap at any point during the development of ProstaSignal™; (d) any consideration, analysis, review, or evaluation of GenomeDx's 22-gene Decipher® panel or any of GenomeDx's patents or patent applications during the gene selection process; and (e) all internal analyses, memoranda, laboratory notebooks, publications, databases, datasets, bioinformatic pipelines, and other materials relied upon or consulted in connection with the selection of the ProstaSignal™ gene panel.

Topic 4: Algorithm Design, Machine-Learning Classifier, and Model Training

The design, architecture, implementation, training, and validation of the computational algorithm and machine-learning classifier used in ProstaSignal™, including without limitation: (a) the design, architecture, and implementation of Helios's gradient-boosted decision tree classifier used in ProstaSignal™, including the selection of the gradient-boosted framework, hyperparameter tuning, and model optimization; (b) the training data used to develop the ProstaSignal™ classifier, including patient cohort sizes, cohort demographics, tissue sample sources, gene-expression measurement platforms, and any preprocessing or normalization steps applied to the data; (c) the feature selection methodology employed to determine which gene-expression features and clinical covariates are input to the classifier; (d) the model validation process, including any cross-validation, holdout validation, or independent validation cohort studies; (e) any consideration, evaluation, comparison, or benchmarking of alternative machine-learning approaches, including random-forest classifiers, support vector machines, neural networks, or logistic regression models, during the development of ProstaSignal™; (f) the process by which ProstaSignal™ generates a continuous risk score ("ProstaScore") ranging from 0 to 100 and the manner in which patients are classified into Low, Intermediate, or High risk categories based on the ProstaScore; and (g) the manner in which ProstaSignal™ integrates the ProstaScore with clinical covariates, including Gleason grade group and pre-operative prostate-specific antigen (PSA) level, to generate a final risk assessment.

Topic 5: Clinical Validation of ProstaSignal™

All clinical validation studies and regulatory activities relating to ProstaSignal™, including without limitation: (a) all clinical validation studies conducted for ProstaSignal™, including the study design, protocol, patient cohorts, inclusion and exclusion criteria, primary and secondary endpoints, statistical analysis plan, and results of each such study; (b) all regulatory submissions to any federal or state agency regarding ProstaSignal™, including any communications with the U.S. Food and Drug Administration, the Centers for Medicare & Medicaid Services, or any state regulatory body, and the current regulatory status of ProstaSignal™ as a laboratory-developed test ("LDT") performed at Helios's CLIA-certified laboratory in San Diego, California; (c) the process by which Helios applied for and obtained MAAA code 0239M for ProstaSignal™ from the Medicare MolDX program in September 2024, including all submissions, correspondence, and interactions with Palmetto GBA or any other Medicare Administrative Contractor; and (d) any peer-reviewed publications, conference presentations, abstracts, posters, or white papers relating to the clinical validation, analytical validation, or clinical utility of ProstaSignal™.

Topic 6: Awareness of GenomeDx Patents and the Decipher® Test

Helios's knowledge, awareness, and understanding of the Patents-in-Suit and GenomeDx's Decipher® test, including without limitation: (a) Helios's knowledge, awareness, and understanding of each of the Patents-in-Suit, namely U.S. Patent No. 10,438,271 (filed June 14, 2016; issued October 8, 2019), U.S. Patent No. 11,204,893 (filed March 22, 2019; issued December 21, 2021), and U.S. Patent No. 11,891,647 (filed September 9, 2021; issued February 6, 2024); (b) the date or dates on which Helios, or any of its officers, directors, employees, or agents, first became aware of each of the Patents-in-Suit, and the circumstances under which such awareness arose; (c) any internal discussions, memoranda, presentations, emails, reports, or other communications referencing the Patents-in-Suit, any claims thereof, or GenomeDx's Decipher® test; and (d) any monitoring, tracking, or surveillance of GenomeDx's patent filings, patent prosecution activities, or published patent applications conducted by or on behalf of Helios at any time.

Topic 7: Freedom-to-Operate Analysis and Patent Clearance

Any freedom-to-operate or patent clearance analysis relating to the Patents-in-Suit, including without limitation: (a) any freedom-to-operate ("FTO") analysis, patent clearance opinion, non-infringement opinion, invalidity opinion, or other patent-related analysis or opinion obtained, commissioned, or prepared by or on behalf of Helios that relates to any of the Patents-in-Suit; (b) the identity of any law firm, attorney, patent agent, consultant, or other professional retained by Helios to perform FTO analysis, patent clearance work, or to provide opinions regarding the Patents-in-Suit, and the scope and terms of each such engagement; (c) any communications with Helios's General Counsel, Sara Whitmore, or any other in-house or outside attorney regarding patent clearance or freedom-to-operate for ProstaSignal™, to the extent such communications are not protected by attorney-client privilege or the work product doctrine, or to the extent such privilege has been waived; and (d) the substance, analysis, methodology, and conclusions of any FTO analysis, patent clearance opinion, or related work product, to the extent privilege has been waived or is inapplicable, including with respect to the thirty-four (34) documents withheld by Helios on privilege grounds and challenged in GenomeDx's pending motion to compel filed on January 30, 2026 (Dkt. No. 72).

Topic 8: Commercial Launch Strategy for ProstaSignal™

The planning, strategy, and execution of the commercial launch of ProstaSignal™, including without limitation: (a) the commercial launch plan, timeline, key milestones, and execution of the ProstaSignal™ launch on October 7, 2024; (b) the role of Derek Mallinson (Vice President, Commercial Operations) in planning, developing, and executing the commercial launch strategy, including his interactions with other members of the Helios leadership team; (c) all pre-launch market research, competitive analysis, and business plans, including any documents, analyses, or communications referencing GenomeDx, the Decipher® test, or GenomeDx's patent portfolio; (d) all marketing materials, sales collateral, promotional presentations, product brochures, website content, physician outreach materials, key opinion leader engagement strategies, and payor engagement strategies relating to ProstaSignal™; and (e) the geographic market entry strategy for ProstaSignal™, including the decision to establish and operate Helios's CLIA-certified laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, and any analysis of the strategic or competitive significance of that location.

Topic 9: Revenue, Pricing, and Financial Performance of ProstaSignal™

Revenue, pricing, reimbursement, and financial performance data relating to ProstaSignal™, including without limitation: (a) ProstaSignal™ test volumes from commercial launch (October 7, 2024) through the present, broken down by month, quarter, and payor, including the approximately 8,400 tests performed from October 2024 through March 2025; (b) the average reimbursement per ProstaSignal™ test (reported by Helios as $3,820 per test) and total estimated revenue of approximately $32,088,000 attributable to ProstaSignal™ for the period October 2024 through March 2025; (c) pricing strategy, payor negotiations, and reimbursement rates obtained from Medicare (including any Medicare local coverage determination) and commercial insurers; (d) the cost structure for performing ProstaSignal™ tests, including all variable costs, fixed costs, marginal cost per test, contribution margin, and gross margin; (e) Helios's total fiscal year 2024 revenue of $71.2 million and the contribution of ProstaSignal™ revenue to total revenue; and (f) all financial projections, budgets, forecasts, and long-range plans relating to ProstaSignal™, including projections of test volumes, revenue, market share, and profitability.

Topic 10: Competitive intelligence and Market Positioning

Helios's competitive intelligence activities and market positioning strategy relating to the genomic prostate cancer prognostic testing market, including without limitation: (a) all competitive intelligence reports, market analyses, industry reports, and strategic assessments regarding the genomic prostate cancer prognostic testing market, including the competitive landscape, market size, growth projections, and key participants; (b) Helios's awareness that GenomeDx held approximately 74% of the relevant market prior to the launch of ProstaSignal™ and approximately 68% of the relevant market following the launch of ProstaSignal™, and the basis for Helios's knowledge of such market share data; (c) any analysis of ProstaSignal™'s impact on GenomeDx's Decipher® test volume, market position, revenue, or customer relationships; (d) all internal assessments of the competitive advantages or disadvantages of ProstaSignal™ relative to the Decipher® test, including any comparison of clinical performance, pricing, turnaround time, gene panel composition, or clinical evidence; and (e) any communications with investors, including Corinth Ventures Fund III, LP and Aether Life Sciences Partners, regarding Helios's competitive positioning, market share objectives, or strategy for competing with GenomeDx.

Topic 11: Communications with Investors Regarding GenomeDx Patents and ProstaSignal™

All communications with Helios's investors regarding GenomeDx, the Patents-in-Suit, or intellectual property risk associated with ProstaSignal™, including without limitation: (a) all communications, presentations, memoranda, reports, letters, and other materials shared with Corinth Ventures Fund III, LP (holder of approximately 58.7% of Helios equity, managed by Priya Chandrasekaran), Aether Life Sciences Partners (holder of approximately 11.0% of Helios equity), or any other investor in Helios that reference the Patents-in-Suit, GenomeDx, the Decipher® test, or intellectual property risk associated with ProstaSignal™; (b) all board of directors meeting minutes, investor update presentations, board decks, and investment committee materials discussing or referencing patent infringement risk, freedom-to-operate analysis, litigation risk, or this litigation; (c) all due diligence materials, information memoranda, data room contents, and investor presentations provided to Corinth Ventures, Aether, or any other prospective or actual investor regarding Helios's intellectual property position, patent landscape analysis, or risk of patent infringement; and (d) the documents at issue in GenomeDx's pending motion to compel (Dkt. No. 72), including the documents responsive to Requests for Production Nos. 22, 23, and 31, and the thirty-four (34) documents challenged from Helios's privilege log.

Topic 12: Invalidity and Non-Infringement Contentions

The factual bases for Helios's invalidity and non-infringement contentions, including without limitation: (a) the factual bases for Helios's contentions of invalidity of the Patents-in-Suit under 35 U.S.C. §§ 101, 102, and 103 as set forth in its Answer and Counterclaims filed May 12, 2025 (Dkt. No. 18); (b) Helios's contentions that ProstaSignal™ does not infringe any asserted claim of the '271 Patent, the '893 Patent, or the '647 Patent, including both literal infringement and infringement under the doctrine of equivalents; (c) identification and description of all prior art relied upon by Helios in support of its invalidity contentions, including Nakamura et al. (U.S. Patent No. 9,617,340), Gagnon (International Patent Publication No. WO 2018/065413), Thornberry et al. ("Computational Models for Post-Prostatectomy Recurrence Prediction," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301, March 2015), and Klein et al. ("A Genomic Classifier Improves Prediction of Metastatic Disease within 5 Years after Surgery in Node-Negative High-Risk Prostate Cancer Patients," European Urology, Vol. 66, No. 1, pp. 45–52, 2014); (d) any additional prior art not yet identified in Helios's discovery responses, preliminary invalidity contentions, or other disclosures; and (e) the factual basis for Helios's counterclaim of unenforceability of the Patents-in-Suit, including any allegations of inequitable conduct before the United States Patent and Trademark Office.

Topic 13: Document Retention and Preservation

Helios's document retention, preservation, and litigation hold practices relating to this litigation, including without limitation: (a) Helios's document retention policies, practices, and schedules applicable to documents and ESI relating to ProstaSignal™ development, commercial operations, and communications regarding GenomeDx or the Patents-in-Suit, including any automatic deletion or destruction schedules; (b) the implementation, scope, and communication of any litigation hold issued by Helios following service of the Complaint on April 14, 2025, including the identity of all persons who received litigation hold notices and the instructions provided to them; (c) identification of all custodians from whom documents and ESI were collected, searched, reviewed, and produced in this litigation, including the criteria used to select such custodians; (d) any destruction, loss, alteration, spoliation, or unavailability of documents or ESI relevant to this litigation, whether occurring before or after the implementation of any litigation hold; and (e) all ESI systems, platforms, databases, repositories, servers, cloud storage services, and communication systems used by Helios to create, store, or maintain documents and ESI relating to ProstaSignal™, including email systems, document management systems, laboratory information management systems, and collaboration platforms.

Topic 14: Third-Party Relationships and Collaborations

Helios's relationships, agreements, and collaborations with third parties relating to ProstaSignal™, including without limitation: (a) any agreements, contracts, collaborations, partnerships, joint ventures, or other arrangements with third parties relating to the development, validation, commercialization, distribution, or marketing of ProstaSignal™; (b) any licensing discussions, negotiations, offers, or agreements with GenomeDx or any other entity regarding the Patents-in-Suit or any other patent or intellectual property right relating to genomic prostate cancer testing; (c) any agreements, collaborations, material transfer agreements, data use agreements, or other arrangements with academic institutions, universities, research organizations, hospitals, medical centers, or clinical trial sites relating to ProstaSignal™ development, validation, or clinical studies; and (d) Helios's relationship with any contract research organizations, reference laboratories, technology vendors, software developers, bioinformatics service providers, or other third-party service providers involved in the development, validation, manufacture, or performance of ProstaSignal™ testing.

RESERVATION OF RIGHTS

GenomeDx reserves the right to modify, amend, supplement, or narrow the topics listed in Exhibit A upon reasonable written notice to Helios. GenomeDx further reserves the right to notice additional depositions of Helios employees, officers, directors, agents, and former employees in their individual capacities pursuant to Federal Rule of Civil Procedure 30(b)(1). GenomeDx additionally reserves the right to seek an extension of the fact discovery deadline from the Court if necessary to complete the depositions noticed herein or other outstanding discovery, subject to a showing of good cause under Federal Rule of Civil Procedure 16(b)(4) and the applicable standards of this District. This Notice is served without prejudice to, and is independent of, GenomeDx's pending motion to compel the production of documents (filed January 30, 2026, Dkt. No. 72) and GenomeDx's planned third-party subpoena directed to Corinth Ventures Fund III, LP. GenomeDx does not waive, and expressly reserves, all rights and remedies available to it under the Federal Rules of Civil Procedure, the Local Rules of this Court, and applicable law.

Dated: February 28, 2026

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Catherine Bloom (California Bar No. 198472) Peter Vassiliev (California Bar No. 287613) Wendy Schultz (California Bar No. 304851)

CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-5600 Facsimile: (415) 773-5601

Email: cbloom@calderwoodharkness.com

Email: pvassiliev@calderwoodharkness.com

Email: wschultz@calderwoodharkness.com

Attorneys for Plaintiff Genome Dx Therapeutics Inc.

CERTIFICATE OF SERVICE

I, Catherine Bloom, hereby certify that on February 28, 2026, I caused a true and correct copy of the foregoing PLAINTIFF'S NOTICE OF RULE 30(b)(6) DEPOSITION OF DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC., including Exhibit A thereto, to be served upon counsel for Defendant Helios Precision Diagnostics, Inc. via electronic mail and through the Court's CM/ECF electronic filing system, which will send notification of such filing to the following counsel of record:

Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 426-8300

Email: mpellegrini@ridgecrestkirkpatrick.com

Email: dforrest@ridgecrestkirkpatrick.com

Email: ochu@ridgecrestkirkpatrick.com

and

350 South Grand Avenue, Suite 2800 Los Angeles, California 90071 Telephone: (213) 892-4500

By: ________

Catherine Bloom

GENOME DX THERAPEUTICS INC., a Delaware corporation,	Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent -->	Hon. Jessica W. Langston

Magistrate Judge David R. Cabrera

PLAINTIFF'S NOTICE OF RULE 30(b)(6) DEPOSITION OF DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC.

HELIOS PRECISION DIAGNOSTICS, INC., a Delaware corporation,

Defendant.

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION
PLAINTIFF'S NOTICE OF RULE 30(b)(6) DEPOSITION OF DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC.
TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
PLEASE TAKE NOTICE that, pursuant to Federal Rules of Civil Procedure 30(b)(1) and 30(b)(6), and the Scheduling Order entered June 18, 2025 by the Honorable Jessica W. Langston, Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx") hereby notices the deposition upon oral examination of Defendant Helios Precision Diagnostics, Inc. ("Helios") by one or more officers, directors, managing agents, or other persons designated by Helios to testify on its behalf regarding the matters described in reasonable particularity in Exhibit A attached hereto and incorporated herein by reference. This Notice is served on February 28, 2026. Fact discovery in this matter closes on March 6, 2026, pursuant to the Scheduling Order entered June 18, 2025. Helios is required to designate and produce one or more witnesses who are prepared to testify fully and non-evasively on each of the fourteen (14) topics set forth in Exhibit A.
I. DEPOSITION LOGISTICS
A. Date and Time
The deposition noticed herein shall commence on a date and time to be agreed upon by the parties no later than the fact discovery close date of March 6, 2026, or as otherwise ordered by the Court. GenomeDx's counsel will confer with Helios's counsel in good faith to identify mutually agreeable dates within the remaining fact discovery period. In the event the parties are unable to agree upon a date within five (5) business days of service of this Notice, GenomeDx reserves the right to seek relief from Magistrate Judge David R. Cabrera, including an order setting the deposition date. Proposed dates shall be determined by agreement of counsel and communicated in writing. The deposition shall begin at 9:30 a.m. Pacific Time and shall continue day-to-day until completed.
B. Location.  The deposition shall take place at the offices of Calderwood & Harkness LLP, located at 555 Mission Street, Suite 3100, San Francisco, California 94105, or at such other location as the parties may agree upon in writing, including the offices of Ridgecrest Durneval LLP, located at 350 South Grand Avenue, Suite 2800, Los Angeles, California 90071. In the alternative, the deposition may be conducted by remote means via contemporaneous video transmission if the parties so agree in writing or if the Court so orders.
C. Recording Method
The deposition will be recorded by stenographic means before a certified court reporter and simultaneously by videography pursuant to Federal Rule of Civil Procedure 30(b)(3)(A). GenomeDx reserves the right to record the deposition by additional means permitted under Rule 30(b)(3), including but not limited to audio recording. GenomeDx will bear the initial costs of the stenographic recording and videography. All original transcripts and recordings shall be maintained in accordance with the Stipulated Protective Order entered December 18, 2025.
D. Counsel.  Plaintiff GenomeDx will be represented at the deposition by the following counsel:
Catherine Bloom (California Bar No. 198472) Peter Vassiliev (California Bar No. 287613) Wendy Schultz (California Bar No. 304851) CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-5600 Facsimile: (415) 773-5601
Email: cbloom@calderwoodharkness.com
Email: pvassiliev@calderwoodharkness.com
Email: wschultz@calderwoodharkness.com
Defendant Helios is represented by the following counsel of record:
Marcus Pellegrini (California Bar No. 221094; Massachusetts Bar No. 682415) Danielle Forrest (California Bar No. 256738) Owen Chu (California Bar No. 311209) RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 426-8300 Facsimile: (617) 426-8301
and
350 South Grand Avenue, Suite 2800 Los Angeles, California 90071 Telephone: (213) 892-4500 Facsimile: (213) 892-4501
Email: mpellegrini@ridgecrestkirkpatrick.com
Email: dforrest@ridgecrestkirkpatrick.com
Email: ochu@ridgecrestkirkpatrick.com
II. DESIGNATION OF CORPORATE REPRESENTATIVE(S)
Pursuant to Federal Rule of Civil Procedure 30(b)(6), Helios is required to designate one or more persons to testify on its behalf regarding each of the topics described with reasonable particularity in Exhibit A. The persons so designated need not be officers or directors of Helios but must be persons who consent to testify on Helios's behalf and who are prepared to testify fully and completely regarding each topic for which they are designated. Helios's obligation under Rule 30(b)(6) is not limited to designating persons with pre-existing personal knowledge of the noticed topics. Rather, Helios bears an affirmative duty to prepare its designees by having them review all relevant documents and materials, consult with current and former employees, officers, directors, and agents who possess knowledge of the noticed topics, and educate themselves so that they can provide complete, knowledgeable, and binding testimony on behalf of the corporation.
GenomeDx requests that Helios identify its designated witness or witnesses no later than ten (10) calendar days prior to the scheduled deposition date. Such identification shall be provided in writing to GenomeDx's counsel and shall include the following information for each designated witness: (a) the witness's full legal name; (b) the witness's current title and position with Helios; and (c) the specific Exhibit A topics as to which each witness will testify. If Helios designates more than one witness, it shall clearly identify the topics allocated to each witness so that the deposition may proceed in an orderly manner.
GenomeDx reserves the right to depose individual fact witnesses separately and in their individual capacities, including without limitation Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), Derek Mallinson (Vice President, Commercial Operations), Sara Whitmore (General Counsel), and Dr. Anton Rykov (Senior Scientist, Bioinformatics). Nothing in this Notice shall be construed as a waiver of GenomeDx's right to notice such individual depositions, nor shall the designation of any of these individuals as a Rule 30(b)(6) witness preclude GenomeDx from deposing them in their individual capacities.
III. DOCUMENT PRODUCTION REQUEST
Pursuant to Federal Rule of Civil Procedure 30(b)(2), GenomeDx hereby requests that Helios produce at the deposition all non-privileged documents, communications, and electronically stored information ("ESI") within Helios's possession, custody, or control that relate to each of the fourteen (14) topics set forth in Exhibit A, to the extent such documents have not already been produced in response to Plaintiff's First Set of Requests for Production of Documents (Nos. 1–47), served on January 27, 2026. This request encompasses documents in any format, including but not limited to paper records, electronic files, emails, text messages, instant messages, Meridian Solutions or Teams messages, presentations, spreadsheets, memoranda, reports, handwritten notes, and voicemail recordings.
All documents produced in connection with this Notice shall be produced in accordance with, and shall be subject to, the Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 47), including the "Confidential" and "Highly Confidential — Attorneys' Eyes Only" designation categories set forth therein. Helios shall designate the confidentiality level of each document at the time of production, consistent with the terms of the Stipulated Protective Order.
To the extent Helios withholds any responsive documents on the basis of attorney-client privilege, the work product doctrine, or any other privilege or protection, Helios shall provide a privilege log identifying each such document with sufficient particularity to permit GenomeDx to assess the claim of privilege, consistent with Federal Rule of Civil Procedure 26(b)(5)(A) and the requirements set forth in the Court's Standing Order on discovery.
IV. DEFINITIONS AND INSTRUCTIONS
A. Definitions.  As used in this Notice and in Exhibit A attached hereto, the following terms shall have the meanings ascribed below:
1.  "Helios" means Defendant Helios Precision Diagnostics, Inc., a Delaware corporation, including its officers, directors, employees, agents, representatives, subsidiaries, affiliates, predecessors, successors, and any person acting or purporting to act on its behalf.
2.  "ProstaSignal™" or "ProstaSignal™ Genomic Classifier" means Helios's 24-gene expression-based prognostic test for prostate cancer post-radical prostatectomy, commercially launched on or about October 7, 2024, and marketed under Molecular Analysis for Therapy Choice (MAAA) code 0239M, including all versions, iterations, and modifications thereof.
3.  "GenomeDx" means Plaintiff Genome Dx Therapeutics Inc., a Delaware corporation.
4.  "Decipher®" means GenomeDx's proprietary 22-gene genomic classifier test for prostate cancer prognosis, marketed under MAAA code 0047M.
5.  "Patents-in-Suit" means, collectively, (a) U.S. Patent No. 10,438,271 (entitled "Gene Expression Profiles for Predicting Prostate Cancer Outcomes," filed June 14, 2016, issued October 8, 2019) ("the '271 Patent"); (b) U.S. Patent No. 11,204,893 (entitled "Genomic Classifiers for Prognosing Post-Surgical Cancer Recurrence," filed March 22, 2019, issued December 21, 2021) ("the '893 Patent"); and (c) U.S. Patent No. 11,891,647 (entitled "Systems and Methods for Integrated Genomic and Clinical Risk Stratification," filed September 9, 2021, issued February 6, 2024) ("the '647 Patent"). Any reference to an individual patent by its short-form designation (e.g., "the '271 Patent") refers to the corresponding patent as identified herein.
6.  "Document" shall have the broadest meaning permitted under Federal Rule of Civil Procedure 34(a) and includes all writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations—stored in any medium from which information can be obtained—including electronically stored information ("ESI") such as emails, text messages, instant messages, Meridian Solutions and Northgate Data Systems messages, voicemails, spreadsheets, databases, presentations, source code, and metadata.
7.  "Communication" means any oral, written, or electronic exchange, transfer, or dissemination of information between two or more persons, including but not limited to conversations, meetings, telephone calls, video conferences, letters, memoranda, emails, text messages, instant messages, and social media posts.
8.  "Relating to" means referring to, concerning, discussing, describing, reflecting, evidencing, constituting, mentioning, pertaining to, or having any connection with, in whole or in part, directly or indirectly.
9.  "You" or "Your" means Helios, as defined above.
10.  "Person" means any natural person, corporation, partnership, limited liability company, joint venture, association, governmental entity, or any other legal or business entity.
11.  "Corinth Ventures" means Corinth Ventures Fund III, LP, a Delaware limited partnership, including its general partner, managing members, investment professionals, and any person acting on its behalf.
12.  "Aether" means Aether Life Sciences Partners, including its general partner, managing members, investment professionals, and any person acting on its behalf.
B. Instructions.  
1.  The designee or designees produced by Helios must be prepared to testify regarding Helios's knowledge, information, and belief as a corporate entity, not merely the designee's own personal knowledge. The testimony of a Rule 30(b)(6) designee binds the corporation to the same extent as an answer to an interrogatory or a request for admission.
2.  Helios is obligated to prepare its designated witnesses thoroughly and in good faith by, among other things, reviewing all relevant documents and ESI (whether or not produced in discovery), consulting with current and former employees, officers, directors, and agents who possess knowledge of the noticed topics, reviewing deposition transcripts and declarations in this matter, and taking all other reasonable steps necessary to ensure that each designee can provide full, complete, and non-evasive testimony regarding each topic for which that designee is designated.
3.  The deposition will be conducted in accordance with the Federal Rules of Civil Procedure, including Rules 30, 32, and 37, and the Local Rules for the United States District Court for the Northern District of California, including Civil Local Rules 30-1 through 30-3.
4.  The Stipulated Protective Order entered by the Court on December 18, 2025 (Dkt. No. 47) shall govern the handling, use, and dissemination of all confidential information disclosed during the deposition. Any testimony designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" shall be handled in accordance with the procedures set forth in the Stipulated Protective Order.
5.  Unless otherwise agreed by the parties or ordered by the Court, the deposition shall be subject to the seven-hour time limitation prescribed by Federal Rule of Civil Procedure 30(d)(1). GenomeDx reserves the right to seek additional time if warranted by the number of topics, the number of designees, or other circumstances.
EXHIBIT A
TOPICS FOR EXAMINATION PURSUANT TO RULE 30(b)(6)
Helios Precision Diagnostics, Inc. is required to designate one or more persons to testify on its behalf with respect to each of the following topics:
Topic 1: Corporate Organization and Structure
Helios's corporate organization, structure, and governance, including without limitation: (a) the founding and formation of Helios in 2019, its state of incorporation (Delaware), and its qualifications to do business in other states, including the Commonwealth of Massachusetts and the State of California; (b) Helios's principal place of business at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140, and its CLIA-certified laboratory located at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121; (c) Helios's corporate officers, directors, and key personnel, including Dr. Nathan Ashford (Chief Executive Officer), Dr. Elaine Kossack (Chief Scientific Officer), Derek Mallinson (Vice President, Commercial Operations), Sara Whitmore (General Counsel), and Dr. Anton Rykov (Senior Scientist, Bioinformatics), and the responsibilities and reporting relationships of each; (d) Helios's ownership and equity structure, including the ownership interests of Corinth Ventures Fund III, LP (approximately 58.7%), founders (approximately 22.3%), Aether Life Sciences Partners (approximately 11.0%), and the employee equity pool (approximately 8.0%); and (e) Helios's board composition, governance documents (including certificate of incorporation, bylaws, stockholders' agreements, and voting agreements), and investor rights agreements.
Topic 2: Conception, Design, and Development of ProstaSignal™ Genomic Classifier
The conception, design, development, and creation of the ProstaSignal™ Genomic Classifier, including without limitation: (a) the complete timeline of events from initial conception of the ProstaSignal™ concept through its commercial launch on October 7, 2024, including all significant milestones, decision points, and inflection points in the development process; (b) the respective roles and contributions of Dr. Nathan Ashford (who conceived the ProstaSignal™ concept), Dr. Elaine Kossack (who led the development effort), and Dr. Anton Rykov (who developed the algorithmic classifier) in the design and development process, as well as the roles and contributions of all other Helios personnel involved in the development of ProstaSignal™; (c) all internal project milestones, decision gates, design reviews, project plans, timelines, and status reports relating to the development of ProstaSignal™; and (d) the relationship, if any, between the development of ProstaSignal™ and publicly available gene-expression datasets, published literature, or third-party intellectual property, including Helios's contention that its scientists independently developed the ProstaSignal™ classifier beginning in 2020 without reference to or reliance upon GenomeDx's proprietary technology or patents.
Topic 3: Gene Selection Methodology for ProstaSignal™
The process, methodology, and scientific rationale underlying the selection of the genes included in the ProstaSignal™ Genomic Classifier panel, including without limitation: (a) the complete process by which the 24-gene expression panel used in ProstaSignal™ was identified, evaluated, and ultimately selected; (b) the identification of each of the 24 genes in the ProstaSignal™ panel and the specific scientific rationale for the inclusion of each gene; (c) the extent to which 19 of the 24 ProstaSignal™ genes overlap with genes included in GenomeDx's patented gene set, and any analysis, discussion, or awareness of such overlap at any point during the development of ProstaSignal™; (d) any consideration, analysis, review, or evaluation of GenomeDx's 22-gene Decipher® panel or any of GenomeDx's patents or patent applications during the gene selection process; and (e) all internal analyses, memoranda, laboratory notebooks, publications, databases, datasets, bioinformatic pipelines, and other materials relied upon or consulted in connection with the selection of the ProstaSignal™ gene panel.
Topic 4: Algorithm Design, Machine-Learning Classifier, and Model Training
The design, architecture, implementation, training, and validation of the computational algorithm and machine-learning classifier used in ProstaSignal™, including without limitation: (a) the design, architecture, and implementation of Helios's gradient-boosted decision tree classifier used in ProstaSignal™, including the selection of the gradient-boosted framework, hyperparameter tuning, and model optimization; (b) the training data used to develop the ProstaSignal™ classifier, including patient cohort sizes, cohort demographics, tissue sample sources, gene-expression measurement platforms, and any preprocessing or normalization steps applied to the data; (c) the feature selection methodology employed to determine which gene-expression features and clinical covariates are input to the classifier; (d) the model validation process, including any cross-validation, holdout validation, or independent validation cohort studies; (e) any consideration, evaluation, comparison, or benchmarking of alternative machine-learning approaches, including random-forest classifiers, support vector machines, neural networks, or logistic regression models, during the development of ProstaSignal™; (f) the process by which ProstaSignal™ generates a continuous risk score ("ProstaScore") ranging from 0 to 100 and the manner in which patients are classified into Low, Intermediate, or High risk categories based on the ProstaScore; and (g) the manner in which ProstaSignal™ integrates the ProstaScore with clinical covariates, including Gleason grade group and pre-operative prostate-specific antigen (PSA) level, to generate a final risk assessment.
Topic 5: Clinical Validation of ProstaSignal™
All clinical validation studies and regulatory activities relating to ProstaSignal™, including without limitation: (a) all clinical validation studies conducted for ProstaSignal™, including the study design, protocol, patient cohorts, inclusion and exclusion criteria, primary and secondary endpoints, statistical analysis plan, and results of each such study; (b) all regulatory submissions to any federal or state agency regarding ProstaSignal™, including any communications with the U.S. Food and Drug Administration, the Centers for Medicare & Medicaid Services, or any state regulatory body, and the current regulatory status of ProstaSignal™ as a laboratory-developed test ("LDT") performed at Helios's CLIA-certified laboratory in San Diego, California; (c) the process by which Helios applied for and obtained MAAA code 0239M for ProstaSignal™ from the Medicare MolDX program in September 2024, including all submissions, correspondence, and interactions with Palmetto GBA or any other Medicare Administrative Contractor; and (d) any peer-reviewed publications, conference presentations, abstracts, posters, or white papers relating to the clinical validation, analytical validation, or clinical utility of ProstaSignal™.
Topic 6: Awareness of GenomeDx Patents and the Decipher® Test
Helios's knowledge, awareness, and understanding of the Patents-in-Suit and GenomeDx's Decipher® test, including without limitation: (a) Helios's knowledge, awareness, and understanding of each of the Patents-in-Suit, namely U.S. Patent No. 10,438,271 (filed June 14, 2016; issued October 8, 2019), U.S. Patent No. 11,204,893 (filed March 22, 2019; issued December 21, 2021), and U.S. Patent No. 11,891,647 (filed September 9, 2021; issued February 6, 2024); (b) the date or dates on which Helios, or any of its officers, directors, employees, or agents, first became aware of each of the Patents-in-Suit, and the circumstances under which such awareness arose; (c) any internal discussions, memoranda, presentations, emails, reports, or other communications referencing the Patents-in-Suit, any claims thereof, or GenomeDx's Decipher® test; and (d) any monitoring, tracking, or surveillance of GenomeDx's patent filings, patent prosecution activities, or published patent applications conducted by or on behalf of Helios at any time.
Topic 7: Freedom-to-Operate Analysis and Patent Clearance
Any freedom-to-operate or patent clearance analysis relating to the Patents-in-Suit, including without limitation: (a) any freedom-to-operate ("FTO") analysis, patent clearance opinion, non-infringement opinion, invalidity opinion, or other patent-related analysis or opinion obtained, commissioned, or prepared by or on behalf of Helios that relates to any of the Patents-in-Suit; (b) the identity of any law firm, attorney, patent agent, consultant, or other professional retained by Helios to perform FTO analysis, patent clearance work, or to provide opinions regarding the Patents-in-Suit, and the scope and terms of each such engagement; (c) any communications with Helios's General Counsel, Sara Whitmore, or any other in-house or outside attorney regarding patent clearance or freedom-to-operate for ProstaSignal™, to the extent such communications are not protected by attorney-client privilege or the work product doctrine, or to the extent such privilege has been waived; and (d) the substance, analysis, methodology, and conclusions of any FTO analysis, patent clearance opinion, or related work product, to the extent privilege has been waived or is inapplicable, including with respect to the thirty-four (34) documents withheld by Helios on privilege grounds and challenged in GenomeDx's pending motion to compel filed on January 30, 2026 (Dkt. No. 72).
Topic 8: Commercial Launch Strategy for ProstaSignal™
The planning, strategy, and execution of the commercial launch of ProstaSignal™, including without limitation: (a) the commercial launch plan, timeline, key milestones, and execution of the ProstaSignal™ launch on October 7, 2024; (b) the role of Derek Mallinson (Vice President, Commercial Operations) in planning, developing, and executing the commercial launch strategy, including his interactions with other members of the Helios leadership team; (c) all pre-launch market research, competitive analysis, and business plans, including any documents, analyses, or communications referencing GenomeDx, the Decipher® test, or GenomeDx's patent portfolio; (d) all marketing materials, sales collateral, promotional presentations, product brochures, website content, physician outreach materials, key opinion leader engagement strategies, and payor engagement strategies relating to ProstaSignal™; and (e) the geographic market entry strategy for ProstaSignal™, including the decision to establish and operate Helios's CLIA-certified laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, and any analysis of the strategic or competitive significance of that location.
Topic 9: Revenue, Pricing, and Financial Performance of ProstaSignal™
Revenue, pricing, reimbursement, and financial performance data relating to ProstaSignal™, including without limitation: (a) ProstaSignal™ test volumes from commercial launch (October 7, 2024) through the present, broken down by month, quarter, and payor, including the approximately 8,400 tests performed from October 2024 through March 2025; (b) the average reimbursement per ProstaSignal™ test (reported by Helios as $3,820 per test) and total estimated revenue of approximately $32,088,000 attributable to ProstaSignal™ for the period October 2024 through March 2025; (c) pricing strategy, payor negotiations, and reimbursement rates obtained from Medicare (including any Medicare local coverage determination) and commercial insurers; (d) the cost structure for performing ProstaSignal™ tests, including all variable costs, fixed costs, marginal cost per test, contribution margin, and gross margin; (e) Helios's total fiscal year 2024 revenue of $71.2 million and the contribution of ProstaSignal™ revenue to total revenue; and (f) all financial projections, budgets, forecasts, and long-range plans relating to ProstaSignal™, including projections of test volumes, revenue, market share, and profitability.
Topic 10: Competitive intelligence and Market Positioning
Helios's competitive intelligence activities and market positioning strategy relating to the genomic prostate cancer prognostic testing market, including without limitation: (a) all competitive intelligence reports, market analyses, industry reports, and strategic assessments regarding the genomic prostate cancer prognostic testing market, including the competitive landscape, market size, growth projections, and key participants; (b) Helios's awareness that GenomeDx held approximately 74% of the relevant market prior to the launch of ProstaSignal™ and approximately 68% of the relevant market following the launch of ProstaSignal™, and the basis for Helios's knowledge of such market share data; (c) any analysis of ProstaSignal™'s impact on GenomeDx's Decipher® test volume, market position, revenue, or customer relationships; (d) all internal assessments of the competitive advantages or disadvantages of ProstaSignal™ relative to the Decipher® test, including any comparison of clinical performance, pricing, turnaround time, gene panel composition, or clinical evidence; and (e) any communications with investors, including Corinth Ventures Fund III, LP and Aether Life Sciences Partners, regarding Helios's competitive positioning, market share objectives, or strategy for competing with GenomeDx.
Topic 11: Communications with Investors Regarding GenomeDx Patents and ProstaSignal™
All communications with Helios's investors regarding GenomeDx, the Patents-in-Suit, or intellectual property risk associated with ProstaSignal™, including without limitation: (a) all communications, presentations, memoranda, reports, letters, and other materials shared with Corinth Ventures Fund III, LP (holder of approximately 58.7% of Helios equity, managed by Priya Chandrasekaran), Aether Life Sciences Partners (holder of approximately 11.0% of Helios equity), or any other investor in Helios that reference the Patents-in-Suit, GenomeDx, the Decipher® test, or intellectual property risk associated with ProstaSignal™; (b) all board of directors meeting minutes, investor update presentations, board decks, and investment committee materials discussing or referencing patent infringement risk, freedom-to-operate analysis, litigation risk, or this litigation; (c) all due diligence materials, information memoranda, data room contents, and investor presentations provided to Corinth Ventures, Aether, or any other prospective or actual investor regarding Helios's intellectual property position, patent landscape analysis, or risk of patent infringement; and (d) the documents at issue in GenomeDx's pending motion to compel (Dkt. No. 72), including the documents responsive to Requests for Production Nos. 22, 23, and 31, and the thirty-four (34) documents challenged from Helios's privilege log.
Topic 12: Invalidity and Non-Infringement Contentions
The factual bases for Helios's invalidity and non-infringement contentions, including without limitation: (a) the factual bases for Helios's contentions of invalidity of the Patents-in-Suit under 35 U.S.C. §§ 101, 102, and 103 as set forth in its Answer and Counterclaims filed May 12, 2025 (Dkt. No. 18); (b) Helios's contentions that ProstaSignal™ does not infringe any asserted claim of the '271 Patent, the '893 Patent, or the '647 Patent, including both literal infringement and infringement under the doctrine of equivalents; (c) identification and description of all prior art relied upon by Helios in support of its invalidity contentions, including Nakamura et al. (U.S. Patent No. 9,617,340), Gagnon (International Patent Publication No. WO 2018/065413), Thornberry et al. ("Computational Models for Post-Prostatectomy Recurrence Prediction," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301, March 2015), and Klein et al. ("A Genomic Classifier Improves Prediction of Metastatic Disease within 5 Years after Surgery in Node-Negative High-Risk Prostate Cancer Patients," European Urology, Vol. 66, No. 1, pp. 45–52, 2014); (d) any additional prior art not yet identified in Helios's discovery responses, preliminary invalidity contentions, or other disclosures; and (e) the factual basis for Helios's counterclaim of unenforceability of the Patents-in-Suit, including any allegations of inequitable conduct before the United States Patent and Trademark Office.
Topic 13: Document Retention and Preservation
Helios's document retention, preservation, and litigation hold practices relating to this litigation, including without limitation: (a) Helios's document retention policies, practices, and schedules applicable to documents and ESI relating to ProstaSignal™ development, commercial operations, and communications regarding GenomeDx or the Patents-in-Suit, including any automatic deletion or destruction schedules; (b) the implementation, scope, and communication of any litigation hold issued by Helios following service of the Complaint on April 14, 2025, including the identity of all persons who received litigation hold notices and the instructions provided to them; (c) identification of all custodians from whom documents and ESI were collected, searched, reviewed, and produced in this litigation, including the criteria used to select such custodians; (d) any destruction, loss, alteration, spoliation, or unavailability of documents or ESI relevant to this litigation, whether occurring before or after the implementation of any litigation hold; and (e) all ESI systems, platforms, databases, repositories, servers, cloud storage services, and communication systems used by Helios to create, store, or maintain documents and ESI relating to ProstaSignal™, including email systems, document management systems, laboratory information management systems, and collaboration platforms.
Topic 14: Third-Party Relationships and Collaborations
Helios's relationships, agreements, and collaborations with third parties relating to ProstaSignal™, including without limitation: (a) any agreements, contracts, collaborations, partnerships, joint ventures, or other arrangements with third parties relating to the development, validation, commercialization, distribution, or marketing of ProstaSignal™; (b) any licensing discussions, negotiations, offers, or agreements with GenomeDx or any other entity regarding the Patents-in-Suit or any other patent or intellectual property right relating to genomic prostate cancer testing; (c) any agreements, collaborations, material transfer agreements, data use agreements, or other arrangements with academic institutions, universities, research organizations, hospitals, medical centers, or clinical trial sites relating to ProstaSignal™ development, validation, or clinical studies; and (d) Helios's relationship with any contract research organizations, reference laboratories, technology vendors, software developers, bioinformatics service providers, or other third-party service providers involved in the development, validation, manufacture, or performance of ProstaSignal™ testing.
RESERVATION OF RIGHTS
GenomeDx reserves the right to modify, amend, supplement, or narrow the topics listed in Exhibit A upon reasonable written notice to Helios. GenomeDx further reserves the right to notice additional depositions of Helios employees, officers, directors, agents, and former employees in their individual capacities pursuant to Federal Rule of Civil Procedure 30(b)(1). GenomeDx additionally reserves the right to seek an extension of the fact discovery deadline from the Court if necessary to complete the depositions noticed herein or other outstanding discovery, subject to a showing of good cause under Federal Rule of Civil Procedure 16(b)(4) and the applicable standards of this District. This Notice is served without prejudice to, and is independent of, GenomeDx's pending motion to compel the production of documents (filed January 30, 2026, Dkt. No. 72) and GenomeDx's planned third-party subpoena directed to Corinth Ventures Fund III, LP. GenomeDx does not waive, and expressly reserves, all rights and remedies available to it under the Federal Rules of Civil Procedure, the Local Rules of this Court, and applicable law.
Dated: February 28, 2026
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Catherine Bloom (California Bar No. 198472) Peter Vassiliev (California Bar No. 287613) Wendy Schultz (California Bar No. 304851)
CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-5600 Facsimile: (415) 773-5601
Email: cbloom@calderwoodharkness.com
Email: pvassiliev@calderwoodharkness.com
Email: wschultz@calderwoodharkness.com
Attorneys for Plaintiff Genome Dx Therapeutics Inc.
CERTIFICATE OF SERVICE
I, Catherine Bloom, hereby certify that on February 28, 2026, I caused a true and correct copy of the foregoing PLAINTIFF'S NOTICE OF RULE 30(b)(6) DEPOSITION OF DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC., including Exhibit A thereto, to be served upon counsel for Defendant Helios Precision Diagnostics, Inc. via electronic mail and through the Court's CM/ECF electronic filing system, which will send notification of such filing to the following counsel of record:
Marcus Pellegrini, Esq. Danielle Forrest, Esq. Owen Chu, Esq. RIDGECREST DURNEVAL LLP One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 426-8300
Email: mpellegrini@ridgecrestkirkpatrick.com
Email: dforrest@ridgecrestkirkpatrick.com
Email: ochu@ridgecrestkirkpatrick.com
and
350 South Grand Avenue, Suite 2800 Los Angeles, California 90071 Telephone: (213) 892-4500
By: ________
Catherine Bloom
GENOME DX THERAPEUTICS INC., a Delaware corporation, | Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent --> | Hon. Jessica W. Langston
Magistrate Judge David R. Cabrera
v.
PLAINTIFF'S NOTICE OF RULE 30(b)(6) DEPOSITION OF DEFENDANT HELIOS PRECISION DIAGNOSTICS, INC.
HELIOS PRECISION DIAGNOSTICS, INC., a Delaware corporation,
<!-- indent:2 -->Defendant.<!-- /indent -->