1013-00005 · Genome Dx Therapeutics Inc · Correspondence/Insurance

insurance-coverage-letter-greystone.docx DOCUMENT Litigation

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CALDERWOOD & HARKNESS LLP Attorneys at Law

555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 882-7400 Facsimile: (415) 882-7401 www.calderwoodharkness.com

February 3, 2026

VIA CERTIFIED MAIL AND ELECTRONIC MAIL

Claims Department Greystone Specialty Insurance Co. 400 Constitution Plaza, Suite 1500 Hartford, CT 06103

Attention: Director of Claims, intellectual Property Enforcement Coverage

Re:

Policy Number: GSI-IP-2024-07812 Named Insured: Genome Dx Therapeutics Inc. Policy Type: Intellectual Property Enforcement Insurance Policy Period: January 1, 2025 – December 31, 2025 Litigation Reference: Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, U.S. District Court for the Northern District of California

Dear Director of Claims:

I. Introduction and Purpose of Correspondence

I am Alan Ngo, a partner in the intellectual Property Practice Group of Calderwood & Harkness LLP and the designated Billing Partner responsible for insurance and cost-recovery matters in the above-referenced litigation. I write on behalf of our client, Genome Dx Therapeutics Inc. ("GenomeDx"), a Delaware corporation headquartered at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130, which is the Named Insured under Greystone Specialty Insurance Co. ("Greystone") intellectual Property Enforcement Insurance Policy No. GSI-IP-2024-07812 (the "Policy").

The purpose of this correspondence is fourfold. First, this letter serves as formal notice to Greystone of a covered patent infringement enforcement action initiated by GenomeDx during the Policy Period, specifically the litigation captioned Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, currently pending in the United States District Court for the Northern District of California before the Honorable Jessica W. Langston. Second, this letter provides a comprehensive summary of the legal fees, e-discovery costs, and related expenditures incurred to date under the Policy through January 31, 2026. Third, this letter sets forth projected costs through the anticipated trial date in February 2027 and analyzes the coverage implications under the Policy's deductible and co-insurance provisions. Fourth, and of particular urgency, this letter requests written confirmation from Greystone regarding the status of coverage for this claim in light of the expiration of the current Policy Period on December 31, 2025, and the pendency of renewal discussions.

Calderwood & Harkness LLP was engaged as outside litigation counsel for GenomeDx effective March 12, 2025, pursuant to a written engagement letter executed on that date. Catherine Bloom, a partner in our intellectual Property Practice Group with twenty-two years of patent litigation experience, serves as Responsible Partner for all substantive litigation matters. I serve as Billing Partner with responsibility for client billing, budgeting, and insurance reporting. A copy of the engagement letter is enclosed for Greystone's reference.

We respectfully request Greystone's prompt attention to the matters set forth herein, given the approaching close of fact discovery on March 6, 2026 and the imminent satisfaction of the Policy's $2,500,000 deductible.

II. Notice of Litigation — Covered Claim

A. Overview of the Action

The following summarizes the key identifying information for the litigation:

This action is an offensive patent enforcement action brought by GenomeDx against Helios Precision Diagnostics, Inc. ("Helios"), a competing molecular diagnostics company. GenomeDx asserts infringement of three United States patents directed to methods and systems for genomic classification and risk stratification in prostate cancer diagnosis and prognosis. The complaint alleges willful and deliberate infringement by Helios through its commercial marketing and sale of a competing genomic classifier test. As an offensive enforcement action initiated by GenomeDx, this litigation falls squarely within the Policy's coverage for costs and expenses incurred by the Named Insured in prosecuting patent infringement claims to protect its intellectual property portfolio.

B. Patents-in-Suit. GenomeDx asserts three United States patents in this action, each of which is listed on the Policy's schedule of covered intellectual property and is part of GenomeDx's broader patent portfolio. The patents-in-suit are summarized below:

1. U.S. Patent No. 10,438,271 ("the '271 Patent")

• Title: "Methods for Predicting Prostate Cancer Outcomes Using Multi-Gene Expression Classifiers"

• Filing Date: June 14, 2016

• Issue Date: October 8, 2019

• Expiration Date: June 14, 2036

• Asserted Claims: 1, 3, 5, 7, 12, and 18

The '271 Patent is directed to methods of predicting clinical outcomes in prostate cancer patients using multi-gene expression classifiers trained through machine-learning techniques. The independent claims recite a method comprising obtaining a biological sample from a patient, measuring expression levels of a defined set of genes, inputting those expression levels into a trained machine-learning classifier, and generating a prognostic risk score. The dependent claims specify particular gene sets, classifier architectures, and risk stratification thresholds.

2. U.S. Patent No. 11,204,893 ("the '893 Patent")

• Title: "Genomic Classifier Systems and Methods for Post-Surgical Cancer Prognosis"

• Filing Date: March 22, 2019 (continuation of the '271 Patent application)

• Issue Date: December 21, 2021

• Expiration Date: June 14, 2036

• Asserted Claims: 1, 2, 9, 14, and 20

The '893 Patent is a continuation of the '271 Patent application and is directed to systems and methods for generating genomic classifiers for post-surgical cancer prognosis. The claims of the '893 Patent recite, among other elements, a random-forest classifier trained on a specified set of gene expression features, and methods for combining genomic classifier output with clinical variables to generate a composite risk assessment.

3. U.S. Patent No. 11,891,647 ("the '647 Patent")

• Title: "Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models"

• Filing Date: September 9, 2021

• Issue Date: February 6, 2024

• Expiration Date: September 9, 2041

• Asserted Claims: 1, 4, 6, 11, and 15

The '647 Patent claims improved methods for genomic risk stratification that integrate biomarker expression data with clinical variables such as Gleason grade group and pre-operative prostate-specific antigen ("PSA") levels. The claims recite a combined model that generates a multi-tier risk classification (e.g., low, intermediate, and high risk categories) to guide post-surgical treatment decisions.

These three patents are part of GenomeDx's broader intellectual property portfolio, which currently includes forty-seven (47) issued U.S. patents, twelve (12) pending U.S. patent applications, and nineteen (19) international patent family members across jurisdictions including the European Patent Office, Japan, Canada, Australia, and China. The patents-in-suit represent the core of GenomeDx's proprietary genomic classifier technology underpinning its commercially successful Decipher® prostate cancer test.

C. Defendant. Helios Precision Diagnostics, Inc. ("Helios") is a Delaware corporation headquartered at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140. Helios operates a CLIA-certified clinical laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, which serves as the primary site for processing and analysis of its diagnostic tests.

Helios was founded in 2019 and currently employs approximately 215 individuals across its Cambridge and San Diego facilities. According to publicly available information and documents obtained during discovery, Helios reported fiscal year 2024 revenue of approximately $71.2 million. Helios is majority-owned by Corinth Ventures Fund III, LP, a venture capital fund that holds approximately 58.7% of Helios's equity. The identity and financial position of Corinth Ventures is relevant to GenomeDx's ability to collect any damages award, and GenomeDx anticipates serving a third-party subpoena on Corinth Ventures in the near term.

Helios is represented in this litigation by the law firm Ridgecrest Durneval LLP, with lead partner Marcus Pellegrini serving as lead trial counsel. Ridgecrest Durneval's team has been active and aggressive in its defense, as reflected in the procedural history summarized below.

D. Accused Product and Infringement Allegations

The accused instrumentality in this action is Helios's ProstaSignal™ Genomic Classifier, a 24-gene expression-based prognostic test designed for prostate cancer patients who have undergone radical prostatectomy. ProstaSignal™ was commercially launched on October 7, 2024, and has been actively marketed to urologists and oncologists in competition with GenomeDx's well-established Decipher® prostate cancer test.

The infringement allegations are summarized as follows:

Gene overlap. Nineteen (19) of the twenty-four (24) genes analyzed by the ProstaSignal™ test overlap with GenomeDx's patented 22-gene Decipher® panel. This substantial overlap is central to GenomeDx's theory that ProstaSignal™ practices the claimed gene sets recited in the patents-in-suit.

Classifier architecture. ProstaSignal™ utilizes a gradient-boosted decision tree classifier to generate its prognostic output. GenomeDx asserts that this classifier architecture constitutes literal infringement of the "trained machine-learning classifier" limitation recited in the '271 Patent and infringement under the doctrine of equivalents of the "random-forest classifier" limitation recited in the '893 Patent. Both gradient-boosted decision trees and random forests are ensemble methods that aggregate predictions from multiple decision trees, and GenomeDx's expert analysis (to be presented through expert testimony) will establish that these methods are functionally equivalent in the context of the claimed inventions.

Risk score and classification output. ProstaSignal™ generates a "ProstaScore" on a 0–100 scale and classifies patients into Low, Intermediate, and High risk categories. This output meets the "multi-tier risk classification" and "prognostic risk score" limitations recited across all three patents-in-suit.

Combined model with clinical variables. ProstaSignal™ combines its ProstaScore genomic output with Gleason grade group and pre-operative PSA levels to generate an integrated risk assessment. This combined approach meets the claim limitations of the '647 Patent, which require the combination of biomarker expression data with specified clinical variables.

Commercial test volume and revenue. Based on information produced in discovery and public disclosures by Helios, the ProstaSignal™ test volume from its commercial launch on October 7, 2024 through March 2025 totaled approximately 8,400 tests at an average reimbursement of $3,820 per test, yielding estimated revenue of approximately $32,088,000. This revenue figure is relevant to both GenomeDx's damages theories and to the overall significance of the claim.

E. GenomeDx's Damages Theories (Summary for Coverage Purposes)

GenomeDx intends to present two alternative damages theories at trial, which are summarized below for coverage evaluation purposes:

Lost Profits Theory. GenomeDx's primary damages theory is based on lost profits. GenomeDx will contend that it would have obtained a substantial share of the tests diverted to ProstaSignal™ in the absence of Helios's infringement. GenomeDx's preliminary analysis estimates that approximately 6,100 tests were diverted from GenomeDx's Decipher® platform to ProstaSignal™ during the relevant period. At GenomeDx's average reimbursement rate of $4,210 per test and an incremental profit margin of approximately 72%, the estimated lost profits amount to $18,490,320. This figure will be refined and supported by expert testimony from GenomeDx's retained damages expert.

Alternative Reasonable Royalty Theory. In the alternative, GenomeDx will present a reasonable royalty damages theory. Based on a hypothetical negotiation analysis, GenomeDx will contend that a reasonable royalty rate for the patents-in-suit would be 18% of Helios's infringing revenue. Applied to the estimated $32,088,000 in ProstaSignal™ revenue through March 2025, this yields a reasonable royalty of $5,775,840. GenomeDx's damages will continue to accrue through the date of judgment.

Injunctive Relief. In addition to monetary damages, GenomeDx will seek a permanent injunction prohibiting Helios from further infringement and, in the alternative or in addition, an ongoing post-judgment royalty for any continued use of the infringing technology.

III. Procedural History and Current Status

A. Chronological Summary

The following is a chronological summary of significant events in this litigation from inception through the date of this letter:

B. Current Posture

As of the date of this letter, the parties are in the midst of active fact discovery, which is scheduled to close on March 6, 2026. The following summarizes the current posture of the case:

Document productions. Document productions are ongoing. GenomeDx has collected documents from eleven (11) custodians, totaling approximately 482,000 documents comprising 1.7 terabytes of data. Of those, approximately 218,000 documents have been produced to Helios following review for relevance and privilege. Helios has produced approximately 167,000 documents to date. The parties continue to negotiate the scope of certain categories of documents, and additional productions are expected before the close of fact discovery.

discovery disputes. GenomeDx's Motion to Compel production of 34 documents that Helios has withheld on the basis of attorney-client privilege is currently pending before Magistrate Judge Cabrera. GenomeDx contends that certain of these documents reflect pre-suit communications between Helios and its scientific advisory board members that do not qualify as privileged communications, and that Helios's privilege log entries are insufficient. Briefing on this motion is expected to be completed before the close of fact discovery.

Depositions. Multiple depositions are scheduled to take place before the March 6, 2026 fact discovery close, including the Rule 30(b)(6) depositions noticed by both parties and individual depositions of key fact witnesses.

Third-party discovery. GenomeDx has drafted but not yet served a third-party subpoena directed to Corinth Ventures Fund III, LP, Helios's majority shareholder, seeking documents related to Corinth Ventures' investment in Helios, its knowledge of GenomeDx's patent portfolio, and communications relating to the development and launch of the ProstaSignal™ product. This subpoena is expected to be served in the near term.

C. Upcoming Key Dates

The Court's Scheduling Order establishes the following key upcoming dates:

The substantial period between the close of fact discovery and trial reflects the complexity of the claim construction issues and the need for full expert discovery. As set forth below, the projected costs through trial are significant, underscoring the importance of confirming coverage status under the Policy.

IV. Identification of Counsel and Billing Personnel

Calderwood & Harkness LLP's litigation team for this matter consists of the following attorneys, each of whom has recorded time to this matter during the period covered by this report:

These hourly rates are consistent with the rates approved in the Calderwood & Harkness LLP engagement letter dated March 12, 2025, a copy of which is enclosed. We note that the engagement letter contemplates annual rate adjustments effective January 1 of each calendar year. The 2026 rates, which took effect on January 1, 2026, reflect a standard annual adjustment and will be communicated separately. For purposes of this cost summary, all fees incurred through January 31, 2026 are calculated at the 2025 rates set forth above.

In addition to the attorneys listed above, the litigation team utilizes the services of litigation support staff, patent analysts, and paralegals whose time is billed separately and is included in the fee summary below.

V. Summary of Fees and Costs Incurred to Date

A. Legal Fees — Calderwood & Harkness LLP

The following is a summary of legal fees incurred by Calderwood & Harkness LLP for work performed on this matter during the period from March 12, 2025 through January 31, 2026, organized by litigation phase:

The pre-filing investigation phase was particularly intensive, requiring Calderwood & Harkness's team to conduct a thorough infringement analysis of the ProstaSignal™ product relative to the three patents-in-suit. This involved obtaining and reverse-engineering publicly available information regarding ProstaSignal™'s gene panel composition, algorithm architecture, and clinical outputs; conducting detailed claim charting for each of the asserted claims across all three patents; reviewing and analyzing the prosecution histories of the patents-in-suit and related family members; assessing potential invalidity defenses; and preparing the complaint and supporting declarations. The opposition to Helios's Motion to Dismiss under § 101 required substantial briefing and analysis of the evolving case law under Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), and its progeny, particularly as applied to diagnostic method claims in the life sciences field.

A detailed summary table of fees and costs, broken down by timekeeper, phase, and month, is enclosed as an attachment to this letter. Certain entries have been redacted as necessary to preserve attorney-client privilege and work-product protections. We are prepared to provide additional detail upon request, subject to appropriate confidentiality protections.

B. E-discovery Costs — Canfield Document Solutions LLC

GenomeDx has retained Canfield Document Solutions LLC ("Canfield") as its e-discovery vendor for this matter. Sandra Neville serves as the project manager for this engagement. Canfield provides its services through its proprietary "RevealIQ" e-discovery platform, which includes predictive coding and Technology Assisted Review ("TAR") 2.0 capabilities.

E-discovery services performed to date include the following:

• Collection of documents and electronically stored information ("ESI") from eleven (11) custodians, encompassing email, Meridian Solutions messages, shared drive files, laboratory information management system records, and cloud-based collaboration platform content;

• Processing of approximately 482,000 documents totaling 1.7 terabytes of data, including de-duplication, metadata extraction, and text indexing;

• Hosting of all processed documents on the RevealIQ platform for attorney review;

• Review support services, including seed set development, TAR model training and validation, quality control sampling, and workflow management;

• Production of approximately 218,000 documents to Helios in TIFF format with extracted text and metadata in compliance with the Court's Standing Order on ESI and the parties' stipulated ESI protocol.

Total e-discovery costs incurred to date (through January 31, 2026): approximately $520,000.

Canfield has provided a preliminary estimate of total e-discovery costs through trial in the range of $1,400,000 to $1,800,000, based on projected additional collections (including potential third-party ESI), continued hosting through trial, expert review support, trial exhibit preparation, and trial technology services. Accordingly, approximately $880,000 to $1,280,000 in additional e-discovery costs are anticipated beyond the amounts already incurred.

C. Other Costs

In addition to legal fees and e-discovery costs, GenomeDx has incurred miscellaneous litigation-related costs including the following:

• Court filing fees (complaint, motions): approximately $4,500

• Service of process (via professional process server): approximately $1,200

• Travel expenses (counsel travel for Case Management Conference, client meetings, and site inspection of Helios's San Diego laboratory): approximately $18,300

• Court reporter and videographer fees for upcoming depositions (retainer deposits): approximately $12,000

• Westmark Data Systems and other legal research expenses allocated to this matter: approximately $14,000

Total other costs incurred to date: approximately $50,000.

We note that expert engagement costs have not yet been incurred. GenomeDx is currently evaluating candidates for both a technical expert and a damages expert, as discussed below in Section VI. Once experts are formally retained, their fees will constitute a significant additional cost category.

D. Total Costs Incurred to Date

The aggregate total of fees and costs incurred in connection with this litigation through January 31, 2026 is as follows:

As discussed in Section VII below, this total is significant in relation to the Policy's $2,500,000 deductible. Costs incurred to date are approaching but have not yet exceeded the deductible threshold, and the deductible is expected to be satisfied imminently given the current pace of litigation activity.

VI. Projected Costs Through Trial

The Calderwood & Harkness LLP engagement letter dated March 12, 2025 set forth an estimated total litigation budget in the range of $6,800,000 to $9,200,000 through trial. Based on the work performed to date and the current posture of the case, we continue to believe this budget range is reasonable and appropriate. The following is a breakdown of projected remaining costs by phase:

Completion of fact discovery (February – March 2026). The remaining weeks of fact discovery will be intensive. Multiple depositions are scheduled, including Rule 30(b)(6) corporate representative depositions of both parties and individual fact witness depositions. Resolution of the pending motion to compel and potential third-party discovery from Corinth Ventures Fund III, LP will generate additional costs. Estimated remaining fact discovery costs: $350,000 – $500,000.

Expert discovery phase (March – July 2026). GenomeDx intends to retain Dr. Franklin Ogawa as its technical expert on infringement and validity issues. Dr. Ogawa is a professor in the Department of Biomedical Data Science at Stanford University and has served as an expert witness in numerous patent infringement matters involving genomic diagnostics and bioinformatics. GenomeDx also intends to retain Dr. Louise Tremaine, a principal at Ashworth Economics Group LLC, as its damages expert. Dr. Tremaine has extensive experience in patent damages analysis in the life sciences and diagnostics industry. Expert costs include retention, data analysis, report preparation, and deposition testimony. Additionally, depositions of Helios's opposing experts will be required. Estimated expert discovery costs: $700,000 – $1,100,000, of which approximately $400,000 – $700,000 represents combined expert fees for Dr. Ogawa and Dr. Tremaine, with the balance attributable to attorney time for expert report preparation, coordination, and deposition of opposing experts.

Claim construction / *Markman* hearing preparation (July – September 2026). The Markman hearing is a critical juncture in this case. The parties have identified nineteen (19) claim terms for construction, including terms such as "trained machine-learning classifier," "random-forest classifier," "multi-gene expression classifier," "prognostic risk score," and "combined biomarker and clinical variable model." Preparation will include claim construction briefing, tutorial preparation for the Court, and hearing presentation. Estimated costs: $600,000 – $900,000.

Trial preparation (October 2026 – January 2027). Trial preparation will include preparation and filing of pre-trial motions (motions in limine, Daubert motions), witness preparation sessions, preparation of trial exhibits and demonstratives, preparation of proposed jury instructions, and logistical planning for a 7–10 day patent trial. Estimated costs: $1,500,000 – $2,200,000.

Trial (February 2027). The trial is estimated to last 7–10 days before a jury. Trial costs include attorney time for all members of the trial team, travel and lodging, trial technology services, and associated expenses. Estimated costs: $1,150,000 – $2,000,000.

Projected remaining costs (all phases): approximately $4,300,000 – $6,700,000.

Adding the $2,480,000 already incurred to the projected remaining costs yields a projected total cost at completion of $6,780,000 – $9,180,000, which is consistent with the engagement letter budget estimate of $6,800,000 to $9,200,000.

Within these totals, remaining e-discovery costs are estimated at approximately $880,000 – $1,280,000 additional, and combined expert fees for the technical and damages experts are preliminarily estimated at $400,000 – $700,000. Expert fee estimates will be refined upon formal engagement and will be reported to Greystone in subsequent quarterly reports.

VII. Coverage Analysis and Deductible Status

A. Policy Terms Summary

For ease of reference, the key terms of the Policy are summarized below:

B. Deductible Status

As set forth in Section V above, total costs incurred through January 31, 2026 amount to approximately $2,480,000. The Policy's deductible is $2,500,000. Accordingly, approximately $20,000 remains before the deductible is fully satisfied and Greystone's coverage obligation is triggered.

Based on the current pace of litigation activity — including ongoing document review, discovery motion practice, deposition preparation, and interrogatory responses — we expect that the remaining $20,000 of the deductible will be exhausted during the first or second week of February 2026. Put simply, the deductible is expected to be satisfied imminently, if it has not been satisfied already by the time Greystone receives this correspondence.

We request that Greystone confirm the amount of the deductible and confirm that the costs incurred to date, as summarized herein, are properly credited toward satisfaction of the deductible under the terms of the Policy.

C. Projected Coverage Utilization

Once the deductible is satisfied, Greystone's coverage obligation under the Policy's 80/20 co-insurance structure will be activated. The following analysis illustrates the projected coverage utilization based on the range of estimated total litigation costs:

Low-End Scenario (Total Cost: $6,800,000)

• Total costs: $6,800,000

• Less deductible: ($2,500,000)

• Costs subject to co-insurance: $4,300,000

• Greystone share (80%): $3,440,000

• GenomeDx co-insurance share (20%): $860,000

• GenomeDx total out-of-pocket (deductible + co-insurance): $3,360,000

High-End Scenario (Total Cost: $9,200,000)

• Total costs: $9,200,000

• Less deductible: ($2,500,000)

• Costs subject to co-insurance: $6,700,000

• Greystone share (80%): $5,360,000

• GenomeDx co-insurance share (20%): $1,340,000

• GenomeDx total out-of-pocket (deductible + co-insurance): $3,840,000

Under both scenarios, Greystone's projected obligation falls within the Policy's $10,000,000 aggregate coverage limit. Even at the high end of the projected cost range, Greystone's 80% co-insurance share of $5,360,000 represents approximately 53.6% of the aggregate policy limit, leaving substantial headroom within the coverage limit.

We note that these projections are based on current estimates and are subject to revision as the case progresses. Unforeseen developments — such as additional discovery disputes, interlocutory appeals, or significant motion practice — could cause actual costs to deviate from these projections. We will provide updated projections in our quarterly reports.

VIII. Policy Period Expiration and Renewal Request

We draw Greystone's attention to a matter of significant importance to GenomeDx: the current Policy Period expired on December 31, 2025. The litigation, however, is very much ongoing and is expected to continue through trial in February 2027 — more than thirteen months beyond the expiration of the Policy Period.

GenomeDx's complaint in this action was filed on March 28, 2025, well within the January 1, 2025 – December 31, 2025 Policy Period. The claim was therefore first made during the Policy Period, and GenomeDx submitted timely notice to Greystone in accordance with the Policy's notice provisions.

In light of the foregoing, GenomeDx respectfully requests the following:

1. Confirmation of Continuing Coverage. We request written confirmation from Greystone that the Policy provides tail coverage or continuing coverage for claims first made during the Policy Period. Specifically, we request confirmation that costs and expenses incurred after December 31, 2025 in connection with this claim remain covered under the Policy, subject to the Policy's terms, conditions, and limits.

2. Renewal Terms. To the extent that continuing coverage requires renewal of the Policy, we request that Greystone provide GenomeDx with information regarding renewal terms, including any proposed changes to the coverage limit, deductible amount, co-insurance structure, or premium, as well as the timeline for completing the renewal process.

3. Treatment Under Successor Policy. If a renewed or successor policy is issued, we request confirmation that the current claim will be treated as a continuing covered claim under the renewed or successor policy, without the application of a new or additional deductible, and with full credit for the deductible already satisfied under the current Policy.

The importance of uninterrupted coverage cannot be overstated. GenomeDx has committed substantial resources to this litigation and is relying on the Policy to offset a significant portion of the costs as the case proceeds through expert discovery, claim construction, trial preparation, and trial. Any gap in coverage or uncertainty regarding coverage status could materially affect GenomeDx's litigation strategy and budgeting. We therefore urge Greystone to address these issues promptly.

IX. Reporting Obligations

GenomeDx and Calderwood & Harkness LLP acknowledge their reporting obligations under the Policy, including the obligation to provide timely notice of the claim, periodic status reports, and supporting documentation as reasonably requested by Greystone.

In fulfillment of these obligations, we commit to providing Greystone with quarterly status reports on the litigation, which will include the following:

• Updated summaries of fees and costs incurred during the reporting period;

• Cumulative totals of fees and costs incurred since the inception of the litigation;

• A summary of significant case developments, including court rulings, discovery milestones, and settlement discussions (if any);

• Revised cost projections through trial;

• Updated assessments of the deductible status and projected coverage utilization; and

• Identification of any material changes in case strategy, staffing, or budget assumptions.

We anticipate that the next quarterly report will be submitted on or about April 15, 2026, covering the period from February 1, 2026 through March 31, 2026.

In addition, we are prepared to provide Greystone with copies of key pleadings, court orders, and scheduling orders upon request. To the extent Greystone's claims adjuster or coverage counsel wishes to receive copies of filings on an ongoing basis, we will make arrangements to provide such copies promptly after filing.

We wish to note expressly that all communications between Calderwood & Harkness LLP and Greystone Specialty Insurance Co. regarding this matter are made pursuant to and protected by the common-interest privilege. GenomeDx, Calderwood & Harkness LLP, and Greystone share a common interest in the successful prosecution of GenomeDx's patent infringement claims and in the efficient administration of coverage under the Policy. All information, documents, and communications provided to Greystone are provided without waiver of attorney-client privilege, work-product protection, or any other applicable privilege or immunity. Nothing in this letter or any accompanying materials shall be construed as a waiver of any such privilege or protection.

X. Requests for Confirmation

In summary, GenomeDx respectfully requests that Greystone provide the following confirmations and information at its earliest convenience:

1. Coverage Confirmation. Written confirmation that Policy No. GSI-IP-2024-07812 covers the litigation captioned Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, pending in the U.S. District Court for the Northern District of California, as a covered claim under the Policy.

2. Deductible Credit. Confirmation that the deductible amount is $2,500,000 and that the costs incurred to date, as summarized in this letter and the enclosed cost summary, are properly credited toward satisfaction of the deductible.

3. Co-Insurance and Coverage Limit. Confirmation of the 80/20 co-insurance structure (Greystone: 80%; GenomeDx: 20%) and the $10,000,000 aggregate coverage limit applicable to this claim.

4. Continuing Coverage and Renewal. Confirmation that coverage for this claim continues notwithstanding the December 31, 2025 expiration of the Policy Period, and provision of information regarding renewal terms, renewal premium, and any proposed changes to the Policy's coverage structure for the renewal period.

5. Claims Adjuster Identification. Identification of the assigned claims adjuster or coverage counsel at Greystone who will serve as the primary point of contact for ongoing communications regarding this claim.

6. Invoicing Procedures. Specification of any required claim forms, supplemental documentation, or invoicing procedures that Calderwood & Harkness LLP should follow for submission of covered costs once the deductible is satisfied, including any required formatting, supporting detail, or approval processes.

We would appreciate receiving Greystone's responses to these requests within thirty (30) days of the date of this letter. Given that the deductible is expected to be satisfied imminently and that significant costs will continue to accrue during the active discovery and expert phases, timely confirmation of coverage status and invoicing procedures is essential.

XI. Enclosures

The following documents are enclosed with this letter for Greystone's reference:

1. Copy of the Complaint, Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL (filed March 28, 2025);

2. Copy of the Scheduling Order entered by the Honorable Jessica W. Langston (June 18, 2025);

3. Copy of the Court's Order Denying Defendant's Motion to Dismiss Counts II and III (January 13, 2026);

4. Summary table of fees and costs incurred through January 31, 2026, broken down by phase, timekeeper, and cost category (redacted as necessary to preserve attorney-client privilege and work-product protections); and

5. Copy of the Calderwood & Harkness LLP engagement letter (dated March 12, 2025) (provided for reference to approved hourly rates and litigation budget estimates).

Additional documents, including copies of other significant filings and orders, are available upon request.

XII. Closing

We respectfully urge Greystone's prompt attention to the matters set forth in this letter. The fact discovery close date of March 6, 2026 is imminent, and the litigation is entering a phase of accelerating costs. The deductible is expected to be exceeded in the very near term, and it is essential that the invoicing and reimbursement process be in place before significant covered costs begin to accrue above the deductible threshold. Equally important, GenomeDx requires clarity on the status of continuing coverage and renewal terms as it makes strategic and budgetary decisions regarding the prosecution of this case through trial.

For all billing, insurance, and cost-reporting matters, the primary point of contact is the undersigned:

Alan Ngo, Partner Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, CA 94105 Direct Telephone: (415) 882-7438

Email: ango@calderwoodharkness.com

For substantive litigation matters, Greystone may also contact the Responsible Partner:

Catherine Bloom, Partner Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, CA 94105 Direct Telephone: (415) 882-7422

Email: cbloom@calderwoodharkness.com

We appreciate Greystone's attention to this matter and look forward to a productive working relationship as this coverage claim progresses. Please do not hesitate to contact me directly with any questions or if you require any additional information.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Alan Ngo Partner, intellectual Property Practice Group 555 Mission Street, Suite 3100 San Francisco, CA 94105

cc: (via email)

Catherine Bloom, Partner, Calderwood & Harkness LLP Victoria Sung, General Counsel, Genome Dx Therapeutics Inc. Thomas Brennan, Chief Financial Officer, Genome Dx Therapeutics Inc. Dr. Kevin Ostrowski, Vice President, intellectual Property, Genome Dx Therapeutics Inc.

Enclosures (5)

This letter and all enclosures are confidential and are protected by the attorney-client privilege, the work-product doctrine, and the common-interest privilege. This communication is intended solely for the addressee and the individuals identified in the cc line. Any unauthorized review, use, disclosure, or distribution is prohibited. If you received this communication in error, please contact Alan Ngo at (415) 882-7438 immediately and destroy all copies of this letter and its enclosures.

Item	Detail
Case Caption	Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc.
Case Number	3:25-cv-01847-JWL
Court	U.S. District Court for the Northern District of California
Assigned Judge	Hon. Jessica W. Langston
Magistrate Judge	Hon. David R. Cabrera (assigned for discovery disputes)
Date Complaint Filed	March 28, 2025
Date Defendant Served	April 14, 2025
Nature of Action	Patent infringement — offensive enforcement
Date	Event
March 12, 2025	Calderwood & Harkness LLP engagement letter executed by GenomeDx
March 28, 2025	Complaint filed in the U.S. District Court for the Northern District of California
April 14, 2025	Helios served via registered agent (Hollowell Technologies)
May 12, 2025	Helios filed Answer and Counterclaims (asserting invalidity under 35 U.S.C. §§ 101, 102, and 103; non-infringement; and unenforceability)
May 30, 2025	GenomeDx filed Answer to Counterclaims
June 18, 2025	Initial Case Management Conference held before Judge Langston; Scheduling Order issued
July 14, 2025	Initial disclosures exchanged pursuant to Fed. R. Civ. P. 26(a)(1)
August 4, 2025	Parties exchanged proposed claim construction terms and proposed constructions
September 15, 2025	Helios filed Motion to Dismiss Counts II and III of the Complaint under 35 U.S.C. § 101, arguing that the asserted claims of the '893 Patent and '647 Patent are directed to patent-ineligible subject matter
November 3, 2025	GenomeDx filed Opposition to Motion to Dismiss
November 17, 2025	Helios filed Reply in support of Motion to Dismiss
December 5, 2025	Parties conducted meet-and-confer regarding the terms of a Protective Order
December 18, 2025	Stipulated Protective Order entered by the Court, establishing a two-tier confidentiality designation system: "Confidential" and "Highly Confidential — Attorneys' Eyes Only"
January 13, 2026	Court denied Helios's Motion to Dismiss, holding that Helios's § 101 challenges were premature without the benefit of a full claim construction and a developed factual record
January 27, 2026	Document requests served by both parties (GenomeDx: 47 Requests for Production; Helios: 52 Requests for Production)

January 30, 2026	GenomeDx filed Motion to Compel production of 34 documents withheld by Helios on attorney-client privilege and work-product grounds (briefing schedule set by Magistrate Judge Cabrera)
February 10, 2026	Interrogatories served (GenomeDx: 15 interrogatories; Helios: 17 interrogatories)
February 24, 2026	Helios served Rule 30(b)(6) deposition notice on GenomeDx (12 designated topics)
February 28, 2026	GenomeDx served Rule 30(b)(6) deposition notice on Helios (14 designated topics)
Date	Event
March 6, 2026	Fact discovery close
May 15, 2026	Opening expert reports due
July 10, 2026	Rebuttal expert reports due
September 18, 2026	Markman hearing (claim construction)
February 2027	Trial (estimated 7–10 day patent trial)
Attorney	Role	Experience	2025 Hourly Rate
Catherine Bloom	Responsible Partner, IP	22 years of patent litigation experience with a focus on life sciences, molecular diagnostics, and genomics technologies; lead trial counsel in over 30 patent matters	$1,350/hr
Alan Ngo	Billing Partner, IP	18 years of experience in IP litigation; manages client billing, budgeting, and insurance cost-recovery reporting	$1,275/hr
Peter Vassiliev	Lead Associate, IP	7th-year associate; Ph.D. in Bioinformatics from the University of California, San Diego; leads technical analysis, claim construction briefing, and expert coordination	$875/hr
Wendy Schultz	Working Associate, IP	4th-year associate; former patent examiner at the U.S. Patent and Trademark Office, Art Unit 1634 (molecular biology); responsible for prosecution history analysis, discovery, and deposition preparation	$725/hr
Litigation Phase	Period	Approximate Fees
Pre-filing investigation and complaint preparation	March – April 2025	$420,000
Pleadings phase — answer to counterclaims	May 2025	$185,000
Case management, scheduling, initial disclosures	June – July 2025	$210,000
Claim construction preliminary work, proposed terms exchange	August 2025	$275,000
Opposition to Motion to Dismiss (§ 101)	September – November 2025	$385,000
Protective Order negotiations	November – December 2025	$95,000
Document request drafting, discovery planning, motion to compel	January 2026	$340,000
Total Legal Fees Incurred	March 12, 2025 – January 31, 2026	$1,910,000
Category	Amount

Legal fees (Calderwood & Harkness LLP)	$1,910,000
E-discovery costs (Canfield Document Solutions LLC)	$520,000
Other costs (filing fees, service, travel, court reporters, research)	$50,000
Total Incurred	$2,480,000
Policy Term	Detail
Policy Number	GSI-IP-2024-07812
Named Insured	Genome Dx Therapeutics Inc.
Policy Period	January 1, 2025 – December 31, 2025
Coverage Type	Intellectual Property Enforcement Insurance — Offensive Patent Litigation
Aggregate Coverage Limit	$10,000,000
Deductible	$2,500,000
Co-Insurance	80/20 — Greystone pays 80% of covered costs; GenomeDx retains 20% (above the deductible, up to the aggregate policy limit)

CALDERWOOD & HARKNESS LLP Attorneys at Law
555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 882-7400 Facsimile: (415) 882-7401 www.calderwoodharkness.com
February 3, 2026
VIA CERTIFIED MAIL AND ELECTRONIC MAIL
Claims Department Greystone Specialty Insurance Co. 400 Constitution Plaza, Suite 1500 Hartford, CT 06103
Attention: Director of Claims, intellectual Property Enforcement Coverage
Re:
Policy Number: GSI-IP-2024-07812 Named Insured: Genome Dx Therapeutics Inc. Policy Type: Intellectual Property Enforcement Insurance Policy Period: January 1, 2025 – December 31, 2025 Litigation Reference: Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, U.S. District Court for the Northern District of California
Dear Director of Claims:
I. Introduction and Purpose of Correspondence
I am Alan Ngo, a partner in the intellectual Property Practice Group of Calderwood & Harkness LLP and the designated Billing Partner responsible for insurance and cost-recovery matters in the above-referenced litigation. I write on behalf of our client, Genome Dx Therapeutics Inc. ("GenomeDx"), a Delaware corporation headquartered at 4750 Torrey Pines Road, Suite 300, San Diego, California 92130, which is the Named Insured under Greystone Specialty Insurance Co. ("Greystone") intellectual Property Enforcement Insurance Policy No. GSI-IP-2024-07812 (the "Policy").
The purpose of this correspondence is fourfold. First, this letter serves as formal notice to Greystone of a covered patent infringement enforcement action initiated by GenomeDx during the Policy Period, specifically the litigation captioned Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, currently pending in the United States District Court for the Northern District of California before the Honorable Jessica W. Langston. Second, this letter provides a comprehensive summary of the legal fees, e-discovery costs, and related expenditures incurred to date under the Policy through January 31, 2026. Third, this letter sets forth projected costs through the anticipated trial date in February 2027 and analyzes the coverage implications under the Policy's deductible and co-insurance provisions. Fourth, and of particular urgency, this letter requests written confirmation from Greystone regarding the status of coverage for this claim in light of the expiration of the current Policy Period on December 31, 2025, and the pendency of renewal discussions.
Calderwood & Harkness LLP was engaged as outside litigation counsel for GenomeDx effective March 12, 2025, pursuant to a written engagement letter executed on that date. Catherine Bloom, a partner in our intellectual Property Practice Group with twenty-two years of patent litigation experience, serves as Responsible Partner for all substantive litigation matters. I serve as Billing Partner with responsibility for client billing, budgeting, and insurance reporting. A copy of the engagement letter is enclosed for Greystone's reference.
We respectfully request Greystone's prompt attention to the matters set forth herein, given the approaching close of fact discovery on March 6, 2026 and the imminent satisfaction of the Policy's $2,500,000 deductible.
II. Notice of Litigation — Covered Claim
A. Overview of the Action
The following summarizes the key identifying information for the litigation:
This action is an offensive patent enforcement action brought by GenomeDx against Helios Precision Diagnostics, Inc. ("Helios"), a competing molecular diagnostics company. GenomeDx asserts infringement of three United States patents directed to methods and systems for genomic classification and risk stratification in prostate cancer diagnosis and prognosis. The complaint alleges willful and deliberate infringement by Helios through its commercial marketing and sale of a competing genomic classifier test. As an offensive enforcement action initiated by GenomeDx, this litigation falls squarely within the Policy's coverage for costs and expenses incurred by the Named Insured in prosecuting patent infringement claims to protect its intellectual property portfolio.
B. Patents-in-Suit. GenomeDx asserts three United States patents in this action, each of which is listed on the Policy's schedule of covered intellectual property and is part of GenomeDx's broader patent portfolio. The patents-in-suit are summarized below:
1. U.S. Patent No. 10,438,271 ("the '271 Patent")
• Title: "Methods for Predicting Prostate Cancer Outcomes Using Multi-Gene Expression Classifiers"
• Filing Date: June 14, 2016
• Issue Date: October 8, 2019
• Expiration Date: June 14, 2036
• Asserted Claims: 1, 3, 5, 7, 12, and 18
The '271 Patent is directed to methods of predicting clinical outcomes in prostate cancer patients using multi-gene expression classifiers trained through machine-learning techniques. The independent claims recite a method comprising obtaining a biological sample from a patient, measuring expression levels of a defined set of genes, inputting those expression levels into a trained machine-learning classifier, and generating a prognostic risk score. The dependent claims specify particular gene sets, classifier architectures, and risk stratification thresholds.
2. U.S. Patent No. 11,204,893 ("the '893 Patent")
• Title: "Genomic Classifier Systems and Methods for Post-Surgical Cancer Prognosis"
• Filing Date: March 22, 2019 (continuation of the '271 Patent application)
• Issue Date: December 21, 2021
• Expiration Date: June 14, 2036
• Asserted Claims: 1, 2, 9, 14, and 20
The '893 Patent is a continuation of the '271 Patent application and is directed to systems and methods for generating genomic classifiers for post-surgical cancer prognosis. The claims of the '893 Patent recite, among other elements, a random-forest classifier trained on a specified set of gene expression features, and methods for combining genomic classifier output with clinical variables to generate a composite risk assessment.
3. U.S. Patent No. 11,891,647 ("the '647 Patent")
• Title: "Improved Methods for Genomic Risk Stratification in Prostate Cancer Using Combined Biomarker and Clinical Variable Models"
• Filing Date: September 9, 2021
• Issue Date: February 6, 2024
• Expiration Date: September 9, 2041
• Asserted Claims: 1, 4, 6, 11, and 15
The '647 Patent claims improved methods for genomic risk stratification that integrate biomarker expression data with clinical variables such as Gleason grade group and pre-operative prostate-specific antigen ("PSA") levels. The claims recite a combined model that generates a multi-tier risk classification (e.g., low, intermediate, and high risk categories) to guide post-surgical treatment decisions.
These three patents are part of GenomeDx's broader intellectual property portfolio, which currently includes forty-seven (47) issued U.S. patents, twelve (12) pending U.S. patent applications, and nineteen (19) international patent family members across jurisdictions including the European Patent Office, Japan, Canada, Australia, and China. The patents-in-suit represent the core of GenomeDx's proprietary genomic classifier technology underpinning its commercially successful Decipher® prostate cancer test.
C. Defendant. Helios Precision Diagnostics, Inc. ("Helios") is a Delaware corporation headquartered at 200 CambridgePark Drive, Suite 600, Cambridge, Massachusetts 02140. Helios operates a CLIA-certified clinical laboratory at 9830 Mesa Rim Road, Suite 140, San Diego, California 92121, which serves as the primary site for processing and analysis of its diagnostic tests.
Helios was founded in 2019 and currently employs approximately 215 individuals across its Cambridge and San Diego facilities. According to publicly available information and documents obtained during discovery, Helios reported fiscal year 2024 revenue of approximately $71.2 million. Helios is majority-owned by Corinth Ventures Fund III, LP, a venture capital fund that holds approximately 58.7% of Helios's equity. The identity and financial position of Corinth Ventures is relevant to GenomeDx's ability to collect any damages award, and GenomeDx anticipates serving a third-party subpoena on Corinth Ventures in the near term.
Helios is represented in this litigation by the law firm Ridgecrest Durneval LLP, with lead partner Marcus Pellegrini serving as lead trial counsel. Ridgecrest Durneval's team has been active and aggressive in its defense, as reflected in the procedural history summarized below.
D. Accused Product and Infringement Allegations
The accused instrumentality in this action is Helios's ProstaSignal™ Genomic Classifier, a 24-gene expression-based prognostic test designed for prostate cancer patients who have undergone radical prostatectomy. ProstaSignal™ was commercially launched on October 7, 2024, and has been actively marketed to urologists and oncologists in competition with GenomeDx's well-established Decipher® prostate cancer test.
The infringement allegations are summarized as follows:
Gene overlap. Nineteen (19) of the twenty-four (24) genes analyzed by the ProstaSignal™ test overlap with GenomeDx's patented 22-gene Decipher® panel. This substantial overlap is central to GenomeDx's theory that ProstaSignal™ practices the claimed gene sets recited in the patents-in-suit.
Classifier architecture. ProstaSignal™ utilizes a gradient-boosted decision tree classifier to generate its prognostic output. GenomeDx asserts that this classifier architecture constitutes literal infringement of the "trained machine-learning classifier" limitation recited in the '271 Patent and infringement under the doctrine of equivalents of the "random-forest classifier" limitation recited in the '893 Patent. Both gradient-boosted decision trees and random forests are ensemble methods that aggregate predictions from multiple decision trees, and GenomeDx's expert analysis (to be presented through expert testimony) will establish that these methods are functionally equivalent in the context of the claimed inventions.
Risk score and classification output. ProstaSignal™ generates a "ProstaScore" on a 0–100 scale and classifies patients into Low, Intermediate, and High risk categories. This output meets the "multi-tier risk classification" and "prognostic risk score" limitations recited across all three patents-in-suit.
Combined model with clinical variables. ProstaSignal™ combines its ProstaScore genomic output with Gleason grade group and pre-operative PSA levels to generate an integrated risk assessment. This combined approach meets the claim limitations of the '647 Patent, which require the combination of biomarker expression data with specified clinical variables.
Commercial test volume and revenue. Based on information produced in discovery and public disclosures by Helios, the ProstaSignal™ test volume from its commercial launch on October 7, 2024 through March 2025 totaled approximately 8,400 tests at an average reimbursement of $3,820 per test, yielding estimated revenue of approximately $32,088,000. This revenue figure is relevant to both GenomeDx's damages theories and to the overall significance of the claim.
E. GenomeDx's Damages Theories (Summary for Coverage Purposes)
GenomeDx intends to present two alternative damages theories at trial, which are summarized below for coverage evaluation purposes:
Lost Profits Theory. GenomeDx's primary damages theory is based on lost profits. GenomeDx will contend that it would have obtained a substantial share of the tests diverted to ProstaSignal™ in the absence of Helios's infringement. GenomeDx's preliminary analysis estimates that approximately 6,100 tests were diverted from GenomeDx's Decipher® platform to ProstaSignal™ during the relevant period. At GenomeDx's average reimbursement rate of $4,210 per test and an incremental profit margin of approximately 72%, the estimated lost profits amount to $18,490,320. This figure will be refined and supported by expert testimony from GenomeDx's retained damages expert.
Alternative Reasonable Royalty Theory. In the alternative, GenomeDx will present a reasonable royalty damages theory. Based on a hypothetical negotiation analysis, GenomeDx will contend that a reasonable royalty rate for the patents-in-suit would be 18% of Helios's infringing revenue. Applied to the estimated $32,088,000 in ProstaSignal™ revenue through March 2025, this yields a reasonable royalty of $5,775,840. GenomeDx's damages will continue to accrue through the date of judgment.
Injunctive Relief. In addition to monetary damages, GenomeDx will seek a permanent injunction prohibiting Helios from further infringement and, in the alternative or in addition, an ongoing post-judgment royalty for any continued use of the infringing technology.
III. Procedural History and Current Status
A. Chronological Summary
The following is a chronological summary of significant events in this litigation from inception through the date of this letter:
B. Current Posture
As of the date of this letter, the parties are in the midst of active fact discovery, which is scheduled to close on March 6, 2026. The following summarizes the current posture of the case:
Document productions. Document productions are ongoing. GenomeDx has collected documents from eleven (11) custodians, totaling approximately 482,000 documents comprising 1.7 terabytes of data. Of those, approximately 218,000 documents have been produced to Helios following review for relevance and privilege. Helios has produced approximately 167,000 documents to date. The parties continue to negotiate the scope of certain categories of documents, and additional productions are expected before the close of fact discovery.
discovery disputes. GenomeDx's Motion to Compel production of 34 documents that Helios has withheld on the basis of attorney-client privilege is currently pending before Magistrate Judge Cabrera. GenomeDx contends that certain of these documents reflect pre-suit communications between Helios and its scientific advisory board members that do not qualify as privileged communications, and that Helios's privilege log entries are insufficient. Briefing on this motion is expected to be completed before the close of fact discovery.
Depositions. Multiple depositions are scheduled to take place before the March 6, 2026 fact discovery close, including the Rule 30(b)(6) depositions noticed by both parties and individual depositions of key fact witnesses.
Third-party discovery. GenomeDx has drafted but not yet served a third-party subpoena directed to Corinth Ventures Fund III, LP, Helios's majority shareholder, seeking documents related to Corinth Ventures' investment in Helios, its knowledge of GenomeDx's patent portfolio, and communications relating to the development and launch of the ProstaSignal™ product. This subpoena is expected to be served in the near term.
C. Upcoming Key Dates
The Court's Scheduling Order establishes the following key upcoming dates:
The substantial period between the close of fact discovery and trial reflects the complexity of the claim construction issues and the need for full expert discovery. As set forth below, the projected costs through trial are significant, underscoring the importance of confirming coverage status under the Policy.
IV. Identification of Counsel and Billing Personnel
Calderwood & Harkness LLP's litigation team for this matter consists of the following attorneys, each of whom has recorded time to this matter during the period covered by this report:
These hourly rates are consistent with the rates approved in the Calderwood & Harkness LLP engagement letter dated March 12, 2025, a copy of which is enclosed. We note that the engagement letter contemplates annual rate adjustments effective January 1 of each calendar year. The 2026 rates, which took effect on January 1, 2026, reflect a standard annual adjustment and will be communicated separately. For purposes of this cost summary, all fees incurred through January 31, 2026 are calculated at the 2025 rates set forth above.
In addition to the attorneys listed above, the litigation team utilizes the services of litigation support staff, patent analysts, and paralegals whose time is billed separately and is included in the fee summary below.
V. Summary of Fees and Costs Incurred to Date
A. Legal Fees — Calderwood & Harkness LLP
The following is a summary of legal fees incurred by Calderwood & Harkness LLP for work performed on this matter during the period from March 12, 2025 through January 31, 2026, organized by litigation phase:
The pre-filing investigation phase was particularly intensive, requiring Calderwood & Harkness's team to conduct a thorough infringement analysis of the ProstaSignal™ product relative to the three patents-in-suit. This involved obtaining and reverse-engineering publicly available information regarding ProstaSignal™'s gene panel composition, algorithm architecture, and clinical outputs; conducting detailed claim charting for each of the asserted claims across all three patents; reviewing and analyzing the prosecution histories of the patents-in-suit and related family members; assessing potential invalidity defenses; and preparing the complaint and supporting declarations. The opposition to Helios's Motion to Dismiss under § 101 required substantial briefing and analysis of the evolving case law under Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), and its progeny, particularly as applied to diagnostic method claims in the life sciences field.
A detailed summary table of fees and costs, broken down by timekeeper, phase, and month, is enclosed as an attachment to this letter. Certain entries have been redacted as necessary to preserve attorney-client privilege and work-product protections. We are prepared to provide additional detail upon request, subject to appropriate confidentiality protections.
B. E-discovery Costs — Canfield Document Solutions LLC
GenomeDx has retained Canfield Document Solutions LLC ("Canfield") as its e-discovery vendor for this matter. Sandra Neville serves as the project manager for this engagement. Canfield provides its services through its proprietary "RevealIQ" e-discovery platform, which includes predictive coding and Technology Assisted Review ("TAR") 2.0 capabilities.
E-discovery services performed to date include the following:
• Collection of documents and electronically stored information ("ESI") from eleven (11) custodians, encompassing email, Meridian Solutions messages, shared drive files, laboratory information management system records, and cloud-based collaboration platform content;
• Processing of approximately 482,000 documents totaling 1.7 terabytes of data, including de-duplication, metadata extraction, and text indexing;
• Hosting of all processed documents on the RevealIQ platform for attorney review;
• Review support services, including seed set development, TAR model training and validation, quality control sampling, and workflow management;
• Production of approximately 218,000 documents to Helios in TIFF format with extracted text and metadata in compliance with the Court's Standing Order on ESI and the parties' stipulated ESI protocol.
Total e-discovery costs incurred to date (through January 31, 2026): approximately $520,000.
Canfield has provided a preliminary estimate of total e-discovery costs through trial in the range of $1,400,000 to $1,800,000, based on projected additional collections (including potential third-party ESI), continued hosting through trial, expert review support, trial exhibit preparation, and trial technology services. Accordingly, approximately $880,000 to $1,280,000 in additional e-discovery costs are anticipated beyond the amounts already incurred.
C. Other Costs
In addition to legal fees and e-discovery costs, GenomeDx has incurred miscellaneous litigation-related costs including the following:
• Court filing fees (complaint, motions): approximately $4,500
• Service of process (via professional process server): approximately $1,200
• Travel expenses (counsel travel for Case Management Conference, client meetings, and site inspection of Helios's San Diego laboratory): approximately $18,300
• Court reporter and videographer fees for upcoming depositions (retainer deposits): approximately $12,000
• Westmark Data Systems and other legal research expenses allocated to this matter: approximately $14,000
Total other costs incurred to date: approximately $50,000.
We note that expert engagement costs have not yet been incurred. GenomeDx is currently evaluating candidates for both a technical expert and a damages expert, as discussed below in Section VI. Once experts are formally retained, their fees will constitute a significant additional cost category.
D. Total Costs Incurred to Date
The aggregate total of fees and costs incurred in connection with this litigation through January 31, 2026 is as follows:
As discussed in Section VII below, this total is significant in relation to the Policy's $2,500,000 deductible. Costs incurred to date are approaching but have not yet exceeded the deductible threshold, and the deductible is expected to be satisfied imminently given the current pace of litigation activity.
VI. Projected Costs Through Trial
The Calderwood & Harkness LLP engagement letter dated March 12, 2025 set forth an estimated total litigation budget in the range of $6,800,000 to $9,200,000 through trial. Based on the work performed to date and the current posture of the case, we continue to believe this budget range is reasonable and appropriate. The following is a breakdown of projected remaining costs by phase:
Completion of fact discovery (February – March 2026). The remaining weeks of fact discovery will be intensive. Multiple depositions are scheduled, including Rule 30(b)(6) corporate representative depositions of both parties and individual fact witness depositions. Resolution of the pending motion to compel and potential third-party discovery from Corinth Ventures Fund III, LP will generate additional costs. Estimated remaining fact discovery costs: $350,000 – $500,000.
Expert discovery phase (March – July 2026). GenomeDx intends to retain Dr. Franklin Ogawa as its technical expert on infringement and validity issues. Dr. Ogawa is a professor in the Department of Biomedical Data Science at Stanford University and has served as an expert witness in numerous patent infringement matters involving genomic diagnostics and bioinformatics. GenomeDx also intends to retain Dr. Louise Tremaine, a principal at Ashworth Economics Group LLC, as its damages expert. Dr. Tremaine has extensive experience in patent damages analysis in the life sciences and diagnostics industry. Expert costs include retention, data analysis, report preparation, and deposition testimony. Additionally, depositions of Helios's opposing experts will be required. Estimated expert discovery costs: $700,000 – $1,100,000, of which approximately $400,000 – $700,000 represents combined expert fees for Dr. Ogawa and Dr. Tremaine, with the balance attributable to attorney time for expert report preparation, coordination, and deposition of opposing experts.
Claim construction / *Markman* hearing preparation (July – September 2026). The Markman hearing is a critical juncture in this case. The parties have identified nineteen (19) claim terms for construction, including terms such as "trained machine-learning classifier," "random-forest classifier," "multi-gene expression classifier," "prognostic risk score," and "combined biomarker and clinical variable model." Preparation will include claim construction briefing, tutorial preparation for the Court, and hearing presentation. Estimated costs: $600,000 – $900,000.
Trial preparation (October 2026 – January 2027). Trial preparation will include preparation and filing of pre-trial motions (motions in limine, Daubert motions), witness preparation sessions, preparation of trial exhibits and demonstratives, preparation of proposed jury instructions, and logistical planning for a 7–10 day patent trial. Estimated costs: $1,500,000 – $2,200,000.
Trial (February 2027). The trial is estimated to last 7–10 days before a jury. Trial costs include attorney time for all members of the trial team, travel and lodging, trial technology services, and associated expenses. Estimated costs: $1,150,000 – $2,000,000.
Projected remaining costs (all phases): approximately $4,300,000 – $6,700,000.
Adding the $2,480,000 already incurred to the projected remaining costs yields a projected total cost at completion of $6,780,000 – $9,180,000, which is consistent with the engagement letter budget estimate of $6,800,000 to $9,200,000.
Within these totals, remaining e-discovery costs are estimated at approximately $880,000 – $1,280,000 additional, and combined expert fees for the technical and damages experts are preliminarily estimated at $400,000 – $700,000. Expert fee estimates will be refined upon formal engagement and will be reported to Greystone in subsequent quarterly reports.
VII. Coverage Analysis and Deductible Status
A. Policy Terms Summary
For ease of reference, the key terms of the Policy are summarized below:
B. Deductible Status
As set forth in Section V above, total costs incurred through January 31, 2026 amount to approximately $2,480,000. The Policy's deductible is $2,500,000. Accordingly, approximately $20,000 remains before the deductible is fully satisfied and Greystone's coverage obligation is triggered.
Based on the current pace of litigation activity — including ongoing document review, discovery motion practice, deposition preparation, and interrogatory responses — we expect that the remaining $20,000 of the deductible will be exhausted during the first or second week of February 2026. Put simply, the deductible is expected to be satisfied imminently, if it has not been satisfied already by the time Greystone receives this correspondence.
We request that Greystone confirm the amount of the deductible and confirm that the costs incurred to date, as summarized herein, are properly credited toward satisfaction of the deductible under the terms of the Policy.
C. Projected Coverage Utilization
Once the deductible is satisfied, Greystone's coverage obligation under the Policy's 80/20 co-insurance structure will be activated. The following analysis illustrates the projected coverage utilization based on the range of estimated total litigation costs:
Low-End Scenario (Total Cost: $6,800,000)
• Total costs: $6,800,000
• Less deductible: ($2,500,000)
• Costs subject to co-insurance: $4,300,000
• Greystone share (80%): $3,440,000
• GenomeDx co-insurance share (20%): $860,000
• GenomeDx total out-of-pocket (deductible + co-insurance): $3,360,000
High-End Scenario (Total Cost: $9,200,000)
• Total costs: $9,200,000
• Less deductible: ($2,500,000)
• Costs subject to co-insurance: $6,700,000
• Greystone share (80%): $5,360,000
• GenomeDx co-insurance share (20%): $1,340,000
• GenomeDx total out-of-pocket (deductible + co-insurance): $3,840,000
Under both scenarios, Greystone's projected obligation falls within the Policy's $10,000,000 aggregate coverage limit. Even at the high end of the projected cost range, Greystone's 80% co-insurance share of $5,360,000 represents approximately 53.6% of the aggregate policy limit, leaving substantial headroom within the coverage limit.
We note that these projections are based on current estimates and are subject to revision as the case progresses. Unforeseen developments — such as additional discovery disputes, interlocutory appeals, or significant motion practice — could cause actual costs to deviate from these projections. We will provide updated projections in our quarterly reports.
VIII. Policy Period Expiration and Renewal Request
We draw Greystone's attention to a matter of significant importance to GenomeDx: the current Policy Period expired on December 31, 2025. The litigation, however, is very much ongoing and is expected to continue through trial in February 2027 — more than thirteen months beyond the expiration of the Policy Period.
GenomeDx's complaint in this action was filed on March 28, 2025, well within the January 1, 2025 – December 31, 2025 Policy Period. The claim was therefore first made during the Policy Period, and GenomeDx submitted timely notice to Greystone in accordance with the Policy's notice provisions.
In light of the foregoing, GenomeDx respectfully requests the following:
1. Confirmation of Continuing Coverage. We request written confirmation from Greystone that the Policy provides tail coverage or continuing coverage for claims first made during the Policy Period. Specifically, we request confirmation that costs and expenses incurred after December 31, 2025 in connection with this claim remain covered under the Policy, subject to the Policy's terms, conditions, and limits.
2. Renewal Terms. To the extent that continuing coverage requires renewal of the Policy, we request that Greystone provide GenomeDx with information regarding renewal terms, including any proposed changes to the coverage limit, deductible amount, co-insurance structure, or premium, as well as the timeline for completing the renewal process.
3. Treatment Under Successor Policy. If a renewed or successor policy is issued, we request confirmation that the current claim will be treated as a continuing covered claim under the renewed or successor policy, without the application of a new or additional deductible, and with full credit for the deductible already satisfied under the current Policy.
The importance of uninterrupted coverage cannot be overstated. GenomeDx has committed substantial resources to this litigation and is relying on the Policy to offset a significant portion of the costs as the case proceeds through expert discovery, claim construction, trial preparation, and trial. Any gap in coverage or uncertainty regarding coverage status could materially affect GenomeDx's litigation strategy and budgeting. We therefore urge Greystone to address these issues promptly.
IX. Reporting Obligations
GenomeDx and Calderwood & Harkness LLP acknowledge their reporting obligations under the Policy, including the obligation to provide timely notice of the claim, periodic status reports, and supporting documentation as reasonably requested by Greystone.
In fulfillment of these obligations, we commit to providing Greystone with quarterly status reports on the litigation, which will include the following:
• Updated summaries of fees and costs incurred during the reporting period;
• Cumulative totals of fees and costs incurred since the inception of the litigation;
• A summary of significant case developments, including court rulings, discovery milestones, and settlement discussions (if any);
• Revised cost projections through trial;
• Updated assessments of the deductible status and projected coverage utilization; and
• Identification of any material changes in case strategy, staffing, or budget assumptions.
We anticipate that the next quarterly report will be submitted on or about April 15, 2026, covering the period from February 1, 2026 through March 31, 2026.
In addition, we are prepared to provide Greystone with copies of key pleadings, court orders, and scheduling orders upon request. To the extent Greystone's claims adjuster or coverage counsel wishes to receive copies of filings on an ongoing basis, we will make arrangements to provide such copies promptly after filing.
We wish to note expressly that all communications between Calderwood & Harkness LLP and Greystone Specialty Insurance Co. regarding this matter are made pursuant to and protected by the common-interest privilege. GenomeDx, Calderwood & Harkness LLP, and Greystone share a common interest in the successful prosecution of GenomeDx's patent infringement claims and in the efficient administration of coverage under the Policy. All information, documents, and communications provided to Greystone are provided without waiver of attorney-client privilege, work-product protection, or any other applicable privilege or immunity. Nothing in this letter or any accompanying materials shall be construed as a waiver of any such privilege or protection.
X. Requests for Confirmation
In summary, GenomeDx respectfully requests that Greystone provide the following confirmations and information at its earliest convenience:
1. Coverage Confirmation. Written confirmation that Policy No. GSI-IP-2024-07812 covers the litigation captioned Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, pending in the U.S. District Court for the Northern District of California, as a covered claim under the Policy.
2. Deductible Credit. Confirmation that the deductible amount is $2,500,000 and that the costs incurred to date, as summarized in this letter and the enclosed cost summary, are properly credited toward satisfaction of the deductible.
3. Co-Insurance and Coverage Limit. Confirmation of the 80/20 co-insurance structure (Greystone: 80%; GenomeDx: 20%) and the $10,000,000 aggregate coverage limit applicable to this claim.
4. Continuing Coverage and Renewal. Confirmation that coverage for this claim continues notwithstanding the December 31, 2025 expiration of the Policy Period, and provision of information regarding renewal terms, renewal premium, and any proposed changes to the Policy's coverage structure for the renewal period.
5. Claims Adjuster Identification. Identification of the assigned claims adjuster or coverage counsel at Greystone who will serve as the primary point of contact for ongoing communications regarding this claim.
6. Invoicing Procedures. Specification of any required claim forms, supplemental documentation, or invoicing procedures that Calderwood & Harkness LLP should follow for submission of covered costs once the deductible is satisfied, including any required formatting, supporting detail, or approval processes.
We would appreciate receiving Greystone's responses to these requests within thirty (30) days of the date of this letter. Given that the deductible is expected to be satisfied imminently and that significant costs will continue to accrue during the active discovery and expert phases, timely confirmation of coverage status and invoicing procedures is essential.
XI. Enclosures
The following documents are enclosed with this letter for Greystone's reference:
1. Copy of the Complaint, Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL (filed March 28, 2025);
2. Copy of the Scheduling Order entered by the Honorable Jessica W. Langston (June 18, 2025);
3. Copy of the Court's Order Denying Defendant's Motion to Dismiss Counts II and III (January 13, 2026);
4. Summary table of fees and costs incurred through January 31, 2026, broken down by phase, timekeeper, and cost category (redacted as necessary to preserve attorney-client privilege and work-product protections); and
5. Copy of the Calderwood & Harkness LLP engagement letter (dated March 12, 2025) (provided for reference to approved hourly rates and litigation budget estimates).
Additional documents, including copies of other significant filings and orders, are available upon request.
XII. Closing
We respectfully urge Greystone's prompt attention to the matters set forth in this letter. The fact discovery close date of March 6, 2026 is imminent, and the litigation is entering a phase of accelerating costs. The deductible is expected to be exceeded in the very near term, and it is essential that the invoicing and reimbursement process be in place before significant covered costs begin to accrue above the deductible threshold. Equally important, GenomeDx requires clarity on the status of continuing coverage and renewal terms as it makes strategic and budgetary decisions regarding the prosecution of this case through trial.
For all billing, insurance, and cost-reporting matters, the primary point of contact is the undersigned:
Alan Ngo, Partner Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, CA 94105 Direct Telephone: (415) 882-7438
Email: ango@calderwoodharkness.com
For substantive litigation matters, Greystone may also contact the Responsible Partner:
Catherine Bloom, Partner Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, CA 94105 Direct Telephone: (415) 882-7422
Email: cbloom@calderwoodharkness.com
We appreciate Greystone's attention to this matter and look forward to a productive working relationship as this coverage claim progresses. Please do not hesitate to contact me directly with any questions or if you require any additional information.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Alan Ngo Partner, intellectual Property Practice Group 555 Mission Street, Suite 3100 San Francisco, CA 94105
cc: (via email)
Catherine Bloom, Partner, Calderwood & Harkness LLP Victoria Sung, General Counsel, Genome Dx Therapeutics Inc. Thomas Brennan, Chief Financial Officer, Genome Dx Therapeutics Inc. Dr. Kevin Ostrowski, Vice President, intellectual Property, Genome Dx Therapeutics Inc.
Enclosures (5)
This letter and all enclosures are confidential and are protected by the attorney-client privilege, the work-product doctrine, and the common-interest privilege. This communication is intended solely for the addressee and the individuals identified in the cc line. Any unauthorized review, use, disclosure, or distribution is prohibited. If you received this communication in error, please contact Alan Ngo at (415) 882-7438 immediately and destroy all copies of this letter and its enclosures.
Item | Detail
Case Caption | Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc.
Case Number | 3:25-cv-01847-JWL
Court | U.S. District Court for the Northern District of California
Assigned Judge | Hon. Jessica W. Langston
Magistrate Judge | Hon. David R. Cabrera (assigned for discovery disputes)
Date Complaint Filed | March 28, 2025
Date Defendant Served | April 14, 2025
Nature of Action | Patent infringement — offensive enforcement
Date | Event
March 12, 2025 | Calderwood & Harkness LLP engagement letter executed by GenomeDx
March 28, 2025 | Complaint filed in the U.S. District Court for the Northern District of California
April 14, 2025 | Helios served via registered agent (Hollowell Technologies)
May 12, 2025 | Helios filed Answer and Counterclaims (asserting invalidity under 35 U.S.C. §§ 101, 102, and 103; non-infringement; and unenforceability)
May 30, 2025 | GenomeDx filed Answer to Counterclaims
June 18, 2025 | Initial Case Management Conference held before Judge Langston; Scheduling Order issued
July 14, 2025 | Initial disclosures exchanged pursuant to Fed. R. Civ. P. 26(a)(1)
August 4, 2025 | Parties exchanged proposed claim construction terms and proposed constructions
September 15, 2025 | Helios filed Motion to Dismiss Counts II and III of the Complaint under 35 U.S.C. § 101, arguing that the asserted claims of the '893 Patent and '647 Patent are directed to patent-ineligible subject matter
November 3, 2025 | GenomeDx filed Opposition to Motion to Dismiss
November 17, 2025 | Helios filed Reply in support of Motion to Dismiss
December 5, 2025 | Parties conducted meet-and-confer regarding the terms of a Protective Order
December 18, 2025 | Stipulated Protective Order entered by the Court, establishing a two-tier confidentiality designation system: "Confidential" and "Highly Confidential — Attorneys' Eyes Only"
January 13, 2026 | Court denied Helios's Motion to Dismiss, holding that Helios's § 101 challenges were premature without the benefit of a full claim construction and a developed factual record
January 27, 2026 | Document requests served by both parties (GenomeDx: 47 Requests for Production; Helios: 52 Requests for Production)
January 30, 2026 | GenomeDx filed Motion to Compel production of 34 documents withheld by Helios on attorney-client privilege and work-product grounds (briefing schedule set by Magistrate Judge Cabrera)
February 10, 2026 | Interrogatories served (GenomeDx: 15 interrogatories; Helios: 17 interrogatories)
February 24, 2026 | Helios served Rule 30(b)(6) deposition notice on GenomeDx (12 designated topics)
February 28, 2026 | GenomeDx served Rule 30(b)(6) deposition notice on Helios (14 designated topics)
Date | Event
March 6, 2026 | Fact discovery close
May 15, 2026 | Opening expert reports due
July 10, 2026 | Rebuttal expert reports due
September 18, 2026 | Markman hearing (claim construction)
February 2027 | Trial (estimated 7–10 day patent trial)
Attorney | Role | Experience | 2025 Hourly Rate
Catherine Bloom | Responsible Partner, IP | 22 years of patent litigation experience with a focus on life sciences, molecular diagnostics, and genomics technologies; lead trial counsel in over 30 patent matters | $1,350/hr
Alan Ngo | Billing Partner, IP | 18 years of experience in IP litigation; manages client billing, budgeting, and insurance cost-recovery reporting | $1,275/hr
Peter Vassiliev | Lead Associate, IP | 7th-year associate; Ph.D. in Bioinformatics from the University of California, San Diego; leads technical analysis, claim construction briefing, and expert coordination | $875/hr
Wendy Schultz | Working Associate, IP | 4th-year associate; former patent examiner at the U.S. Patent and Trademark Office, Art Unit 1634 (molecular biology); responsible for prosecution history analysis, discovery, and deposition preparation | $725/hr
Litigation Phase | Period | Approximate Fees
Pre-filing investigation and complaint preparation | March – April 2025 | $420,000
Pleadings phase — answer to counterclaims | May 2025 | $185,000
Case management, scheduling, initial disclosures | June – July 2025 | $210,000
Claim construction preliminary work, proposed terms exchange | August 2025 | $275,000
Opposition to Motion to Dismiss (§ 101) | September – November 2025 | $385,000
Protective Order negotiations | November – December 2025 | $95,000
Document request drafting, discovery planning, motion to compel | January 2026 | $340,000
Total Legal Fees Incurred | March 12, 2025 – January 31, 2026 | $1,910,000
Category | Amount
Legal fees (Calderwood & Harkness LLP) | $1,910,000
E-discovery costs (Canfield Document Solutions LLC) | $520,000
Other costs (filing fees, service, travel, court reporters, research) | $50,000
Total Incurred | $2,480,000
Policy Term | Detail
Policy Number | GSI-IP-2024-07812
Named Insured | Genome Dx Therapeutics Inc.
Policy Period | January 1, 2025 – December 31, 2025
Coverage Type | Intellectual Property Enforcement Insurance — Offensive Patent Litigation
Aggregate Coverage Limit | $10,000,000
Deductible | $2,500,000
Co-Insurance | 80/20 — Greystone pays 80% of covered costs; GenomeDx retains 20% (above the deductible, up to the aggregate policy limit)

CALDERWOOD & HARKNESS LLP Attorneys at Law

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