CALDERWOOD & HARKNESS LLP Attorneys at Law
555 Mission Street, Suite 3100 San Francisco, California 94105
Telephone: (415) 738-6200 Facsimile: (415) 738-6201 www.calderwoodharkness.com
PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT COMMUNICATION / ATTORNEY WORK PRODUCT
March 14, 2025
TO:
Victoria Sung, Esq. General Counsel Genome Dx Therapeutics Inc. 4750 Torrey Pines Road, Suite 300 San Diego, California 92130
FROM:
Catherine Bloom Partner, intellectual Property Litigation Calderwood & Harkness LLP
RE:
Litigation Hold Notice — Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc. — Preservation of Documents and Electronically Stored Information
CC:
Dr. Kevin Ostrowski, Vice President, intellectual Property, Genome Dx Therapeutics Inc. Alan Ngo, Billing Partner, Calderwood & Harkness LLP Peter Vassiliev, Lead Associate, Calderwood & Harkness LLP
I. PURPOSE AND LEGAL OBLIGATION
As you are aware, Calderwood & Harkness LLP has been retained by Genome Dx Therapeutics Inc. ("GenomeDx" or "GDT") to prosecute patent infringement claims against Helios Precision Diagnostics, Inc. ("Helios") based on Helios's commercialization of the ProstaSignal™ Genomic Classifier. The engagement letter between Calderwood & Harkness and GenomeDx was executed on March 12, 2025. We anticipate filing a complaint in the United States District Court for the Northern District of California on or about March 28, 2025, which is approximately two weeks from the date of this memorandum.
The patents at issue in this litigation are as follows:
• U.S. Patent No. 10,438,271 (the "'271 Patent")
• U.S. Patent No. 11,204,893 (the "'893 Patent")
• U.S. Patent No. 11,891,647 (the "'647 Patent")
The purpose of this memorandum is to advise GenomeDx of its immediate legal obligation to preserve all documents and electronically stored information ("ESI") that may be relevant to the claims, defenses, or subject matter of this litigation. This obligation is not discretionary; it is a mandatory duty imposed by law.
The duty to preserve relevant evidence arises when litigation is reasonably anticipated. Given the execution of the engagement letter on March 12, 2025, and the active preparation of the complaint, the duty to preserve attached no later than the date of this memorandum — March 14, 2025. In practice, to the extent GenomeDx became aware at any earlier date of the potential need to file suit against Helios, the preservation obligation may have arisen at that earlier date as well, and GenomeDx should take care to ensure that no relevant materials have been destroyed since that time.
The consequences of failing to preserve relevant evidence are severe. Under Federal Rule of Civil Procedure 37(e), if ESI that should have been preserved in the anticipation or conduct of litigation is lost because a party failed to take reasonable steps to preserve it, and the lost information cannot be restored or replaced through additional discovery, the court may:
(a) upon a finding of prejudice to another party from loss of the information, order measures no greater than necessary to cure the prejudice; or
(b) only upon a finding that the party acted with the intent to deprive another party of the information's use in the litigation, presume that the lost information was unfavorable to the party, instruct the jury that it may or must presume the information was unfavorable, or dismiss the action or enter a default judgment.
In addition to sanctions under Rule 37(e), courts retain inherent authority to impose additional penalties for spoliation of evidence, including monetary sanctions, issue preclusion, and adverse inference instructions. These sanctions can apply to both the company and to individual officers and employees who were responsible for failing to preserve relevant materials.
This memorandum constitutes the formal litigation hold notice for GenomeDx. Effective immediately, this litigation hold supersedes any routine document retention, archival, or destruction policies currently in effect at GenomeDx with respect to the categories of materials described in this memorandum. No documents or ESI falling within the scope of this hold may be destroyed, deleted, discarded, overwritten, or modified in any way, regardless of whether they would otherwise be subject to scheduled destruction, archival rotation, or other disposition under GenomeDx's existing records management program. This hold will remain in effect until Calderwood & Harkness provides express written notice that the hold has been released.
II. BACKGROUND OF THE LITIGATION
The following summary is provided to give GenomeDx employees who receive this hold notice sufficient context to identify and preserve relevant materials. This summary is necessarily abbreviated and should not be treated as a comprehensive statement of the legal theories or factual allegations that will be asserted in the litigation.
A. The Patents-in-Suit
GenomeDx is the owner by assignment of three United States patents that are at the core of this dispute:
The '271 Patent (U.S. Patent No. 10,438,271). This patent was filed on June 14, 2016, and issued on October 8, 2019. The '271 Patent covers methods for predicting prostate cancer outcomes using multi-gene expression classifiers. The patent claims, among other things, methods of extracting RNA from tumor tissue, measuring expression levels of a defined set of genes, and applying a classifier algorithm to the expression data to generate a prognostic output.
The '893 Patent (U.S. Patent No. 11,204,893). This patent was filed on March 22, 2019, and issued on December 21, 2021. The '893 Patent covers genomic classifier systems and methods for post-surgical cancer prognosis, including systems that integrate gene-expression data with software-implemented classifiers to provide risk-stratification outputs for patients who have undergone radical prostatectomy.
The '647 Patent (U.S. Patent No. 11,891,647). This patent was filed on September 9, 2021, and issued on February 6, 2024. The '647 Patent covers improved methods for genomic risk stratification that combine biomarker expression models with clinical variable models. The claims of this patent reflect the next generation of GenomeDx's classifier methodology, in which genomic data is integrated with patient-specific clinical parameters to achieve enhanced prognostic accuracy.
The named inventors across the three patents include Dr. Rajan Mehta, Dr. Carolyn Xu, Dr. David Petrossian, Dr. Kevin Ostrowski, and Dr. Priya Shah, all of whom are or were GenomeDx employees.
B. GenomeDx's Decipher® Product
GenomeDx's Decipher® Prostate genomic classifier test is a commercially available diagnostic that employs a proprietary 22-gene expression panel to assist in clinical decision-making for prostate cancer patients following radical prostatectomy. The Decipher® test has been commercially available for several years and is widely used by urologists and oncologists nationwide.
C. The Accused Product — Helios ProstaSignal™
Helios Precision Diagnostics, Inc. commercially launched its ProstaSignal™ Genomic Classifier on October 7, 2024. The ProstaSignal™ test is a 24-gene expression-based prognostic test for prostate cancer patients post-radical prostatectomy. Based on GenomeDx's investigation to date, 19 of the 24 genes in the ProstaSignal™ panel overlap with GenomeDx's patented gene set. The ProstaSignal™ test utilizes a gradient-boosted decision tree classifier and produces a "ProstaScore" output that classifies patients into risk categories. These features and functionalities are believed to infringe the claims of the '271, '893, and '647 Patents.
D. Anticipated Legal Theories
GenomeDx will assert infringement under both literal infringement and doctrine of equivalents theories. We anticipate that Helios will raise defenses including, without limitation, non-infringement, invalidity under 35 U.S.C. §§ 101, 102, and 103, and potentially unenforceability. GenomeDx's damages theories will include both lost profits and reasonable royalty analyses. In connection with the damages case, the comparable license agreement between GenomeDx and Veridian Molecular Labs, Inc. (dated April 3, 2022) will be relevant as a licensing comparator, among other evidence.
E. Key Opposing Parties and Counsel
Helios Precision Diagnostics, Inc. is represented by Ridgecrest Durneval LLP. Key individuals at Helios include Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, Derek Mallinson, and Sara Whitmore. Helios's primary investor is Corinth Ventures Fund III, LP.
III. SCOPE OF THE LITIGATION HOLD
A. Effective Date
This litigation hold is effective immediately as of March 14, 2025. It will remain in full force and effect until Calderwood & Harkness LLP provides written notice that the hold has been released. Under no circumstances should any individual at GenomeDx assume that the hold has been released absent express written confirmation from this firm. The pendency of the hold is expected to continue for the full duration of the litigation, including any appeals, and may extend beyond the resolution of the case if post-judgment proceedings or related matters require continued preservation.
From and after the effective date, no documents or ESI within the scope of this hold may be destroyed, deleted, discarded, overwritten, recycled, or altered in any way. This prohibition applies regardless of GenomeDx's standard retention or destruction schedules, and regardless of the medium in which the information is stored. Any automated processes that would otherwise result in the destruction or overwriting of potentially relevant data — including, for example, email auto-deletion rules, backup tape rotation, or messaging platform purge cycles — must be suspended immediately with respect to all materials that fall within the scope of this hold.
B. Definition of "Documents and ESI"
For purposes of this litigation hold, the terms "documents" and "ESI" are to be construed broadly in accordance with the definitions used in the Federal Rules of Civil Procedure. These terms include, without limitation, all information in any form, whether paper or electronic, including but not limited to the following:
• Emails and email attachments
• Text messages (SMS and Westmark Software)
• Instant messages, including communications via Meridian Solutions, Northgate Data Systems, or any similar enterprise messaging platform
• Voicemails (whether stored on company phone systems, mobile devices, or voicemail-to-email systems)
• Memoranda, letters, and correspondence of any kind
• Reports, presentations, and slide decks
• Spreadsheets, databases, and structured data files
• Laboratory notebooks, research notes, and experimental records
• Meeting minutes and agendas
• Board of directors materials, including resolutions, presentations, and minutes
• Financial records, including budgets, forecasts, revenue reports, and accounting workpapers
• Contracts, agreements, term sheets, and letters of intent
• Regulatory submissions, including FDA filings, CLIA documentation, and payer correspondence
• Patent prosecution files, including applications, office actions, responses, declarations, information disclosure statements, and correspondence with the USPTO or foreign patent offices
• Marketing and sales materials, including brochures, promotional content, training materials, and advertising copy
• Website content, including archived versions of web pages
• Social media posts and content published on GenomeDx's official accounts
• Metadata associated with any of the foregoing categories of documents
• Drafts, working copies, and all versions of any document, including documents that were never finalized or sent
The foregoing categories encompass information stored on any medium or in any location, including but not limited to:
• Company servers and network-attached storage
• Cloud-based platforms and services (e.g., Ashgrove Software, Crestline Software, Aldermere Systems, Cobalt Ridge Systems, Larkspur Technologies, box)
• Local hard drives on desktop computers and workstations
• Laptops (company-issued and personal laptops used for company business)
• Mobile devices, including smartphones and tablets (both company-issued devices and personal devices used for company business under BYOD policies)
• External storage media, including USB drives, external hard drives, and optical media
• Backup tapes and disaster recovery systems
• Archival systems and off-site storage facilities
• Paper files maintained in offices, filing cabinets, storage rooms, or off-site records storage
If there is any question whether a particular document, data source, or storage location falls within the scope of this hold, the question should be resolved in favor of preservation, and the matter should be promptly brought to the attention of Victoria Sung or Calderwood & Harkness.
IV. IDENTIFICATION OF KEY CUSTODIANS
The following eleven (11) individuals have been identified as key custodians whose files, documents, and ESI must be preserved in their entirety. Each custodian must be individually notified of this litigation hold and must acknowledge receipt of the hold notice in writing, as described in Section VII below.
The identification of key custodians is based on our current understanding of the individuals who are most likely to possess documents and ESI relevant to the claims, defenses, and subject matter of this litigation. As the case develops, additional custodians may be identified and added to the hold.
1. Dr. Rajan Mehta — Chief Technology Officer
Dr. Mehta is a named inventor on the '271, '893, and '647 Patents and has served as the technical lead for the development of the Decipher® genomic classifier. Dr. Mehta is likely to possess documents relating to the conception and reduction to practice of the inventions claimed in the patents-in-suit, gene selection methodologies, classifier design and architecture, validation studies, and ongoing product development. Dr. Mehta may also possess documents reflecting competitive awareness of Helios and the ProstaSignal™ product, including technical analyses comparing the two products.
2. Dr. Kevin Ostrowski — Vice President, intellectual Property
Dr. Ostrowski is a named inventor on the '647 Patent and oversees GenomeDx's entire patent portfolio, which currently comprises 47 issued U.S. patents, 12 pending U.S. patent applications, and 19 international family members. Dr. Ostrowski possesses patent prosecution files, freedom-to-operate analyses, prior art search reports, patentability opinions, licensing records (including the Veridian Molecular Labs license agreement and related correspondence), IP strategy documents, and correspondence with outside patent counsel. Dr. Ostrowski is also likely to possess documents reflecting GenomeDx's assessment of the Helios patent position and any IP-related competitive analyses.
3. Dr. Miriam Langford — Chief Executive Officer
Dr. Langford possesses strategic communications regarding GenomeDx's competitive positioning vis-à-vis Helios and other competitors in the genomic prostate cancer diagnostics market. Her files are expected to include board communications with Pinnacle Biosciences Capital, LP (GenomeDx's majority equity holder, holding approximately 62.4% of the outstanding equity), business plans, investor presentations, executive committee meeting materials, and correspondence with senior management regarding Helios and the ProstaSignal™ launch. Dr. Langford may also possess documents relating to GenomeDx's decision to initiate this litigation.
4. Victoria Sung — General Counsel
Ms. Sung possesses legal files pertaining to GenomeDx's intellectual property portfolio, licensing agreements (including the Veridian Molecular Labs license), IP enforcement correspondence, and regulatory filings. Her files may also include insurance communications with Greystone Specialty Insurance Co. relating to IP enforcement insurance coverage under policy number GSI-IP-2024-07812, as well as any prior communications with outside counsel regarding Helios or the ProstaSignal™ product. While many of Ms. Sung's files may be protected by the attorney-client privilege or work-product doctrine, they must be preserved in their entirety to facilitate privilege review and any necessary privilege logging.
5. Thomas Brennan — Chief Financial Officer
Mr. Brennan possesses financial records that will be central to GenomeDx's damages case. These records include revenue data (GenomeDx's fiscal year 2024 revenue was approximately $387.6 million), per-test reimbursement records (average reimbursement of approximately $4,210 per test), market share analyses (reflecting an approximate decline from 74% market share prior to the ProstaSignal™ launch to approximately 68% following the launch), EBITDA data (approximately $54.3 million, reflecting a 14.0% margin), incremental margin calculations (approximately 72% incremental margin), budgets, forecasts, and financial projections. Mr. Brennan's files are also expected to include communications with Meridian Commercial Bank, N.A. (GenomeDx's lender under a $75 million revolving credit facility) and Whitfield & Garner LLP (GenomeDx's auditor), particularly to the extent those communications address revenue from the Decipher® product line or the competitive impact of the ProstaSignal™ launch.
6. Dr. Carolyn Xu — Former Principal Scientist
Dr. Xu is a named inventor on the '271 and '893 Patents. She departed GenomeDx in 2023 and is currently employed at Cascadia Genomics, Inc. Although Dr. Xu is no longer a GenomeDx employee, GenomeDx must preserve all documents in its possession, custody, or control that originated from or were sent to Dr. Xu during her tenure at GenomeDx. This includes any files that remain on GenomeDx servers, email archives, shared drives, or other systems to which Dr. Xu had access. Separate preservation steps may be needed with respect to any GenomeDx-owned devices or accounts that Dr. Xu used during her employment. We will coordinate with GenomeDx regarding any communications with Dr. Xu concerning GenomeDx materials she may have retained after her departure. Such communications should be handled through Calderwood & Harkness to ensure appropriate protections.
7. Dr. Priya Shah — Senior Scientist
Dr. Shah is a named inventor on the '647 Patent. She possesses research data, laboratory notebooks, and technical documents relating to the development of the combined biomarker-clinical variable model that is the subject of the '647 Patent's claims. Dr. Shah's files may also contain comparative analyses, internal presentations regarding the advantages of the combined model, and clinical validation data.
8. Dr. David Petrossian — Named Inventor
Dr. Petrossian is a named inventor on the '271 Patent. His current employment status with GenomeDx is to be confirmed. Dr. Petrossian possesses historical research and development documents relating to the original multi-gene expression classifier methods that are the subject of the '271 Patent. If Dr. Petrossian is no longer employed by GenomeDx, the same preservation principles described above for Dr. Xu will apply to his files.
9–11. Additional R&D and Commercial Employees (Approximately 7 Individuals)
We anticipate that approximately seven additional GenomeDx employees — drawn from the company's workforce of approximately 820 employees, including roughly 340 laboratory and R&D personnel — will need to be identified as key custodians. Victoria Sung and Dr. Kevin Ostrowski are requested to identify these individuals based on their knowledge of personnel involved in any of the following areas:
(a) Development, validation, and commercial operations related to the Decipher® test;
(b) Competitive intelligence or market analysis regarding Helios, ProstaSignal™, or other competing genomic prostate cancer diagnostic tests;
(c) Communications with key accounts, commercial payers, or Medicare/MolDX program contacts regarding competitive dynamics in the genomic prostate cancer diagnostics market; and
(d) Any interactions with, or prior employment connections to, Helios personnel (including Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, Derek Mallinson, or Sara Whitmore).
The names and titles of these additional custodians should be confirmed and communicated to Calderwood & Harkness within five (5) business days of the date of this memorandum (i.e., by March 21, 2025). Once identified, these individuals will be added to the hold and provided with individual hold notices and acknowledgment forms.
V. CATEGORIES OF DOCUMENTS AND ESI TO BE PRESERVED
The following categories describe, in greater detail, the types of documents and ESI that must be preserved under this litigation hold. These categories are intended to be illustrative, not exhaustive. If any GenomeDx employee possesses or is aware of documents that are potentially relevant to this litigation but that do not fall squarely within one of the categories listed below, those documents should nonetheless be preserved, and the matter should be brought to the attention of Victoria Sung or Calderwood & Harkness for further guidance.
A. Patent-Related Documents
All documents relating to the prosecution, maintenance, and enforcement of the patents-in-suit must be preserved in their entirety, including but not limited to:
• Complete prosecution files for the '271 Patent (U.S. Patent No. 10,438,271), the '893 Patent (U.S. Patent No. 11,204,893), and the '647 Patent (U.S. Patent No. 11,891,647), including patent applications (provisional and non-provisional), office actions from the USPTO, responses to office actions, amendments, declarations, information disclosure statements (IDS filings), examiner interviews and summaries, notices of allowance, issue fees, and all correspondence with the USPTO.
• Prosecution files for all related patent family members, including continuations, continuations-in-part, divisional applications, and international applications (including PCT applications, national phase entries, and corresponding foreign patent filings).
• Invention disclosures, inventor notebooks, and all records documenting the conception and reduction to practice of any subject matter covered by the patents-in-suit, including any documentary evidence bearing on the dates of conception, diligence in reducing to practice, and the inventive contributions of each named inventor.
• Prior art search reports, patentability opinions, infringement analyses, validity analyses, and freedom-to-operate analyses, whether prepared internally by GenomeDx personnel or by outside counsel (including Calderwood & Harkness or any prior outside counsel).
• All documents relating to the terminal disclaimer filed over the '271 and '893 Patents during prosecution of the '647 Patent, including any analyses or communications regarding the need for and scope of the terminal disclaimer.
• All records relating to the declaration under 37 C.F.R. § 1.132 submitted by Dr. Rajan Mehta during prosecution of the '647 Patent, in which Dr. Mehta provided testimony regarding the unexpected results achieved by the combined genomic-clinical model. This includes all drafts of the declaration, supporting data, and any correspondence between GenomeDx and prosecuting counsel regarding the substance of the declaration.
• Patent assignment records, including all documents reflecting the chain of title from the named inventors to GenomeDx.
• Patent maintenance fee payment records and any communications regarding patent term adjustments or patent term extensions.
B. Product Development and Technical Documents
All documents relating to the development, design, validation, commercialization, and ongoing operation of the Decipher® Prostate genomic classifier must be preserved, including but not limited to:
• Documents relating to the 22-gene expression panel used in the Decipher® test, including the scientific rationale for gene selection, gene-selection methodology, and any evaluations of alternative gene sets.
• Documents relating to reference-gene normalization procedures used in the Decipher® test, including protocols, validation data, and any changes to normalization methods over time.
• Documents relating to the machine-learning classifier architecture employed in the Decipher® test, including the random-forest classifier architecture, model training data, feature engineering documentation, hyperparameter tuning records, cross-validation results, and model performance metrics.
• Clinical validation study protocols, data, and publications, including any studies submitted to regulatory bodies, published in peer-reviewed journals, or presented at scientific conferences.
• FFPE (formalin-fixed, paraffin-embedded) sample processing protocols, including tissue handling procedures, RNA extraction methods, quality control thresholds, and any modifications to processing protocols over time.
• All documents reflecting GenomeDx's knowledge of, or analysis of, the ProstaSignal™ Genomic Classifier, including its 24-gene panel composition, its gradient-boosted decision tree classifier architecture, its ProstaScore output and scoring methodology, and its patient risk classification methodology. This includes any internal memoranda, presentations, reverse-engineering analyses, published literature analyses, or competitive intelligence reports relating to the ProstaSignal™ product.
• Laboratory notebooks, experimental protocols, standard operating procedures (SOPs), and quality control/quality assurance (QC/QA) records relating to the Decipher® test and any related research programs.
C. Competitive intelligence and Market Documents
All documents analyzing Helios, ProstaSignal™, or any other competing genomic prostate cancer diagnostic test must be preserved, including but not limited to:
• Market share analyses, competitive landscape reports, and SWOT analyses relating to the genomic prostate cancer diagnostics market.
• Sales force communications, training materials, and call notes that reference competition with Helios or discuss ProstaSignal™ in any context.
• Documents reflecting GenomeDx's market position, including the approximately 74% market share held prior to the ProstaSignal™ launch and the approximately 68% market share following the launch on October 7, 2024.
• Win/loss analyses, account-level competitive intelligence, and any documents reflecting instances in which GenomeDx lost business or test orders to Helios or ProstaSignal™.
• Internal or external reports analyzing the impact of ProstaSignal™ on GenomeDx's revenue, test volume, pricing, or market position.
D. Licensing and Commercial Agreements
All licensing and commercial agreements relating to the patents-in-suit or to the Decipher® technology must be preserved, including but not limited to:
• The complete executed license agreement between GenomeDx and Veridian Molecular Labs, Inc. dated April 3, 2022, including all amendments, exhibits, schedules, side letters, and ancillary agreements. This agreement — which provides for a 15% running royalty, a $500,000 minimum annual royalty, and a field-of-use limitation to bladder cancer diagnostics — will be relevant to damages analysis. All royalty payment records, audit reports, and correspondence between GenomeDx and Veridian relating to the license must also be preserved.
• Any other license agreements, term sheets, memoranda of understanding, or letters of intent involving the patents-in-suit or related patent family members, whether executed or in draft form.
• Any communications with potential licensees, including expressions of interest, negotiations, or proposals regarding the patented technology.
• Joint development agreements, collaboration agreements, or research agreements that involve or reference the patented technology or the Decipher® product.
E. Financial and Business Records
All financial and business records relevant to GenomeDx's damages theories must be preserved, including but not limited to:
• Revenue, cost, and margin data for the Decipher® test, broken down by time period, geography, payer, and any other available dimensions.
• Per-test reimbursement data, including average reimbursement rates, payer-specific reimbursement rates, and any changes in reimbursement rates over time.
• Test volume data, including total tests performed, tests ordered, and test conversion rates.
• Payer mix data, including the proportion of tests reimbursed by Medicare, commercial payers, and other sources.
• Incremental cost data, including variable costs per test, fixed cost allocations, and contribution margin analyses.
• Documents supporting lost-profits calculations, including evidence supporting the two-supplier market theory (i.e., that GenomeDx and Helios are the only significant competitors in the relevant market), demand elasticity analyses, price erosion analyses, and but-for market share projections.
• All documents provided to or received from Whitfield & Garner LLP (GenomeDx's external auditor) that relate to revenue from the Decipher® product line, the competitive impact of ProstaSignal™, or the financial performance of GenomeDx's diagnostics business.
• All documents provided to or received from Meridian Commercial Bank, N.A. (GenomeDx's lender under the $75 million revolving credit facility) that relate to GenomeDx's financial condition, revenue projections, or the competitive landscape in genomic prostate cancer diagnostics.
• Board presentations, investor materials, and financial packages prepared for Pinnacle Biosciences Capital, LP (62.4% equity holder) or Ridgeline Health Ventures that discuss competitive threats, market share trends, or financial projections affected by the ProstaSignal™ launch.
• Annual and quarterly financial statements, management discussion and analysis materials, and any other periodic financial reports.
F. Regulatory Documents
All regulatory documents relevant to the Decipher® test or GenomeDx's operations must be preserved, including but not limited to:
• The FDA De Novo classification application submitted by GenomeDx on August 15, 2024, and all related correspondence with the FDA, including any requests for additional information, meeting minutes, and pre-submission communications.
• CLIA laboratory certification records, inspection reports, proficiency testing results, and all compliance documentation.
• MolDX program documentation, including all materials relating to the assignment of MAAA code 0047M for the Decipher® test, technical assessments, and coverage determination requests.
• Any communications with the Centers for Medicare & Medicaid Services (CMS), Medicare Administrative Contractors (MACs), or Palmetto GBA's MolDX program regarding competitive testing, coverage of ProstaSignal™, or any other matters relating to genomic prostate cancer diagnostics.
G. Insurance Records
All documents relating to GenomeDx's IP enforcement insurance coverage must be preserved, including but not limited to:
• The Greystone Specialty Insurance Co. IP enforcement insurance policy, policy number GSI-IP-2024-07812, including the policy form, declarations page, endorsements, and all policy amendments.
• All coverage correspondence between GenomeDx and Greystone Specialty Insurance Co. or its representatives, including the claims notice for this litigation, coverage opinions, reservation of rights letters, and any communications regarding the scope of coverage.
• Premium payment records, renewal documentation, and any underwriting materials.
• The policy period is January 1, 2025, through December 31, 2025, but documents from prior policy periods should also be preserved if they relate to the same or similar coverage.
H. Communications with Third Parties
All communications with or about Helios and its personnel must be preserved, including but not limited to:
• Any communications with or references to Helios Precision Diagnostics, Inc., its employees, officers, directors, or agents, including Dr. Nathan Ashford, Dr. Elaine Kossack, Dr. Anton Rykov, Derek Mallinson, and Sara Whitmore.
• Any communications with or references to Helios's investors, including Corinth Ventures Fund III, LP.
• Communications with industry groups, professional organizations, key opinion leaders (KOLs), physicians, payers, or any other third parties that reference ProstaSignal™, Helios, or competition between GenomeDx and Helios in the genomic prostate cancer diagnostics market.
• Any cease-and-desist letters, demand letters, or other enforcement correspondence sent to or received from Helios or its counsel at Ridgecrest Durneval LLP.
• Any communications with former GenomeDx employees who are now employed by Helios or who may have connections to Helios personnel.
VI. IT SYSTEMS AND DATA SOURCES TO BE PRESERVED
In addition to the general preservation obligations described above, GenomeDx's Information Technology department is specifically directed to take the following steps immediately to ensure the preservation of all relevant documents and ESI. Victoria Sung is requested to coordinate with GenomeDx's Chief Information Officer (or equivalent) to ensure that these measures are implemented without delay.
Email Servers. All email accounts belonging to the 11 identified custodians must be preserved in their entirety. Any auto-deletion rules, mailbox size limits, or archival cycling processes that could result in the loss of email data must be suspended for all custodian accounts. The IT department should confirm the integrity of email backups and ensure that historical email data — including emails that may have been moved to archive systems — remains accessible and preserved.
Document Management Systems. A litigation hold must be placed on all document management repositories containing files belonging to, created by, or accessible by the identified custodians. This includes any enterprise document management systems (e.g., Tidewater Systems, Aldermere Systems document libraries, or similar platforms) as well as shared network drives and departmental file shares.
Cloud Platforms. The IT department should identify and preserve all data stored in cloud-based collaboration and productivity tools used by GenomeDx, including but not limited to Westvale Services Inc., Crestline Software (if applicable), Meridian Solutions workspaces, Northgate Data Systems channels and chats, and any other cloud-based platforms used for business communications or document storage. Retention policies for these platforms must be adjusted to prevent the automatic deletion or purging of data for custodian accounts.
Laboratory Information Management Systems (LIMS). All data stored in GenomeDx's LIMS that relates to Decipher® test processing, validation runs, sample tracking, quality control records, and test results must be preserved. This includes both current production data and any historical or archived data.
Bioinformatics Servers and Code Repositories. All versions of classifier algorithms, gene-selection scripts, model training datasets, preprocessing pipelines, and associated documentation must be preserved. This specifically includes all version-control histories maintained in Git repositories (or any other version-control system used by GenomeDx), including all branches, commits, pull requests, and associated metadata. No code, data, or repository history may be deleted, rebased, or force-pushed in a manner that would destroy historical records.
Financial Systems. All data stored in GenomeDx's ERP system, billing platform, revenue cycle management system, and any other financial systems must be preserved to the extent it relates to Decipher® revenue, costs, margins, reimbursement, or financial performance.
Mobile Devices. The IT department should identify all company-issued mobile devices (smartphones, tablets) assigned to the identified custodians, as well as any personal devices used by custodians for company business under GenomeDx's BYOD policy. Text messages (SMS, Westmark Software), messaging application data (e.g., Meridian Services Inc., signals), and voicemails stored on these devices must be preserved. If GenomeDx uses a mobile device management (MDM) solution, retention settings should be adjusted to prevent data loss. Custodians should be instructed not to delete any text messages, voicemails, or messaging application data from their mobile devices.
Backup Tapes and Disaster Recovery Systems. Any rotation, recycling, or overwriting of backup media that may contain data from custodian accounts or relevant systems must be immediately suspended. The IT department should identify all backup tapes and disaster recovery copies that contain data from the relevant time period and ensure their continued preservation and accessibility.
Departing Employee Data — Dr. Carolyn Xu. The IT department should specifically locate, preserve, and segregate all data from Dr. Carolyn Xu's former email account, network shares, local devices, and any other systems she accessed during her employment at GenomeDx. The IT department should confirm whether any data was collected from Dr. Xu's accounts and devices upon her departure in 2023 (e.g., through an exit data collection process or account archival) and ensure the continued preservation of any such data. If Dr. Xu's accounts have been deactivated or deleted, the IT department should determine whether her data is recoverable from backup systems and take all necessary steps to recover and preserve it.
VII. CUSTODIAN ACKNOWLEDGMENT PROCEDURE
Proper implementation of this litigation hold requires that each identified custodian receive individual notice and confirm in writing that he or she understands the preservation obligations. The following procedures must be followed:
1. Distribution of Hold Notice. Victoria Sung is requested to distribute a copy of this memorandum — or, if preferred, an adapted internal version of this memorandum prepared in coordination with and approved by Calderwood & Harkness — to each of the 11 identified custodians within three (3) business days of the date of this memorandum (i.e., by March 19, 2025). The notice should be delivered by email with a read receipt, and a hard copy should be provided to each custodian as well.
2. Written Acknowledgment. Each custodian must sign and return a written acknowledgment form (a template of which is enclosed as Attachment A) confirming:
(a) Receipt of the litigation hold notice;
(b) Understanding of the obligation to preserve all documents and ESI that may be relevant to the litigation, including the obligation to suspend any routine destruction or deletion practices;
(c) Identification of all locations — both physical and electronic — where potentially relevant documents and ESI are stored, including office files, home files, personal devices, personal email accounts (if used for company business), cloud storage accounts, and any other locations; and
(d) Agreement not to destroy, delete, alter, or dispose of any documents or ESI within the scope of this hold.
3. Return of Acknowledgments. Signed acknowledgment forms should be returned to Victoria Sung. Copies of all signed acknowledgment forms must be transmitted to Peter Vassiliev at Calderwood & Harkness LLP for our records. We request that all acknowledgments be collected and transmitted within ten (10) business days of the date of this memorandum (i.e., by March 28, 2025).
4. Special Procedures for Dr. Carolyn Xu. Because Dr. Xu is a former employee now employed at Cascadia Genomics, Inc., GenomeDx's obligations with respect to Dr. Xu's data are limited to preserving all materials in GenomeDx's possession, custody, or control. GenomeDx should not independently contact Dr. Xu regarding any GenomeDx materials she may have retained after her departure. Any such communications should be coordinated through Calderwood & Harkness to ensure that appropriate legal protections are maintained and to avoid any inadvertent waiver of privilege or work-product protection.
5. Non-Responsive Custodians. If any custodian fails to return a signed acknowledgment form within the specified timeframe, Victoria Sung should follow up directly with the custodian and, if necessary, escalate the matter to the custodian's supervisor. Any persistent non-compliance should be reported to Calderwood & Harkness immediately.
VIII. ONGOING OBLIGATIONS AND PERIODIC REMINDERS
The litigation hold is not a one-time event. It imposes an ongoing, affirmative obligation on GenomeDx and each identified custodian to preserve relevant materials for the duration of the hold. The following ongoing obligations must be observed:
Periodic Reminders. GenomeDx must issue periodic reminders to all custodians — at minimum, on a quarterly basis — reaffirming the existence and scope of the litigation hold. These reminders should be in writing (email is sufficient) and should remind custodians of their obligation to preserve all relevant documents and ESI, to refrain from destroying or deleting any materials within the scope of the hold, and to report any changes in their document storage practices or locations. Calderwood & Harkness can provide template reminder language upon request.
Departing Custodians. If any identified custodian departs GenomeDx during the pendency of the litigation hold — whether through resignation, termination, retirement, or any other circumstance — GenomeDx must preserve that individual's documents and ESI before deactivating or deleting the individual's email account, network access, or other system access, and before collecting or wiping any company-issued devices. The IT department should be specifically instructed that no custodian account may be deactivated or deleted without prior approval from Victoria Sung and notification to Calderwood & Harkness.
New Custodians. As the case develops, additional individuals may be identified as key custodians — for example, as a result of information learned during discovery, depositions, or the identification of new witnesses. When new custodians are identified, they must be promptly added to the hold, notified of the preservation obligation, and required to sign written acknowledgment forms.
IT System Changes. Any changes to GenomeDx's IT systems, infrastructure, or data management practices — including but not limited to server migrations, platform transitions, email system upgrades, data center consolidations, records management policy updates, or implementation of new collaboration or messaging tools — must be communicated to Calderwood & Harkness before implementation. Calderwood & Harkness will assess whether the proposed changes could affect the preservation of relevant materials and will advise GenomeDx on any additional steps needed to ensure compliance with the litigation hold.
Reporting of Potential Loss. If any custodian or GenomeDx employee becomes aware that potentially relevant documents or ESI may have been lost, destroyed, deleted, or overwritten — whether intentionally or inadvertently — the matter must be reported immediately to Victoria Sung, who should in turn notify Calderwood & Harkness without delay. Early reporting of potential data loss is critical to enable remediation efforts and to mitigate the risk of sanctions.
IX. E-DISCOVERY COORDINATION
Calderwood & Harkness has engaged Canfield Document Solutions LLC as the e-discovery vendor for this matter. Canfield will provide data collection, processing, hosting, and review support throughout the course of the litigation. The project manager assigned to this engagement is Sandra Neville, who will serve as the primary point of contact for coordination with GenomeDx's IT department and designated internal resources.