Contract analysis

I. Purpose and Executive Summary This memorandum evaluates candidate technical and damages experts for plaintiff GenomeDx's affirmative patent infringement case against Helios Precision Diagnostics, Inc. and provides recommendations for the prompt retention of experts in both categories. The matter is progressing on an accelerated schedule, and early identification, vetting, and engagement of qualified experts is cri

II. Technical Expert — Requirements and Evaluation Criteria A. Scope of Technical Expert's Anticipated Opinions The technical expert retained by GenomeDx will be expected to provide opinions across several interrelated areas. The scope of the anticipated opinions is summarized below and will be refined as fact discovery is completed and as the claim construction positions of both parties crystallize. Infringement Ana

Section 101 / Patent Eligibility. Although the Court has already denied Helios's Motion to Dismiss under § 101, it is possible that Helios will reassert patent-eligibility arguments at the claim construction stage or at summary judgment. The expert must be prepared to address Helios's contention that the asserted claims are directed to abstract mathematical algorithms applied to natural phenomena (i.e., gene expressi

1. Academic Credentials. PhD-level training in computational biology, bioinformatics, computational oncology, or a closely related field. An advanced degree from a recognized research institution is a baseline requirement, and active affiliation with an academic institution or major research center is strongly preferred.

2. Subject-Matter Expertise. Deep expertise in machine-learning classifiers applied to genomic data, with particular knowledge of random forests, gradient-boosted decision trees, and other ensemble methods. The candidate must be conversant with the algorithmic principles underlying these classifiers, their application to high-dimensional gene expression data, and the practical and theoretical differences between the

3. Familiarity with Laboratory Methodologies. Working knowledge of gene expression profiling methodologies relevant to the asserted patents, including processing of formalin-fixed, paraffin-embedded (FFPE) tissue specimens, RNA extraction protocols, reference-gene normalization techniques, and the technical challenges associated with deriving reliable gene expression measurements from archived clinical specimens.

4. Clinical Context. Understanding of prostate cancer molecular diagnostics and clinical genomic risk stratification. The expert should be able to situate the technical discussion within the clinical context, explaining why and how genomic classifiers are used to inform treatment decisions for prostate cancer patients.

5. Publication Record. An active and substantial record of peer-reviewed publications in relevant journals, demonstrating recognition by the scientific community and ongoing engagement with the field.

6. Litigation Experience. Prior experience testifying as an expert witness in patent cases, preferably in the life sciences or molecular diagnostics domain. The candidate must be able to communicate complex technical concepts clearly to a judge and jury, and must have a track record that demonstrates the ability to withstand cross-examination and Daubert challenges.

7. Absence of Conflicts. No conflicts of interest with Helios, its investors (including Corinth Ventures Fund III, LP), or its outside litigation counsel (Ridgecrest Durneval LLP). Any prior relationships with parties, counsel, or key witnesses must be evaluated for potential appearance issues. C. Candidate 1 (Recommended): Dr. Franklin Ogawa, PhD

1. Background and Qualifications. Dr. Franklin Ogawa is a Professor of Computational Oncology at Stanford University, where he has held a faculty appointment for more than fifteen years. He received his PhD in computational biology from the Massachusetts Institute of Technology and completed post-doctoral training at the Broad Institute of MIT and Harvard, where his research focused on machine-learning applications t

2. Prior Testimony and Litigation Experience. Dr. Ogawa has served as a technical expert in three prior patent infringement matters involving molecular diagnostics and bioinformatics methodologies. In each of those engagements, he provided opinions on infringement, validity, and/or claim construction, and prepared detailed expert reports and tutorials for the court. His testimony has been admitted without challenge u

3. Relevance to This Matter. Dr. Ogawa's qualifications are exceptionally well-suited to the technical issues presented in this case. His relevance to the specific matters at issue is summarized as follows: First, Dr. Ogawa possesses specific expertise in the precise technical area at issue: machine-learning classifiers, including random forests and gradient-boosted decision trees, applied to genomic data derived fro

4. Conflict Check. We have conducted a preliminary conflict check on Dr. Ogawa, with the following results: • Dr. Ogawa has no prior consulting or employment relationship with Helios Precision Diagnostics, Inc., Corinth Ventures Fund III, LP (Helios's lead investor), Ridgecrest Durneval LLP (Helios's outside litigation counsel), or any scientists currently or formerly affiliated with Helios. • Dr. Ogawa has no disclo

5. Daubert Considerations. Dr. Ogawa presents an exceptionally strong profile for Daubert admissibility. His qualifications are squarely within the technical subject matter at issue, and there is no gap between his area of expertise and the opinions he will be asked to render. His methodology will be based on well-accepted principles of computational biology and machine learning, including standard analytical framewo

1. Candidate 2: Dr. Marcia Ellison, PhD. Dr. Marcia Ellison is an Associate Professor of Bioinformatics at the University of Michigan. She holds a PhD in bioinformatics and has published approximately thirty-five peer-reviewed articles on gene expression analysis, with a focus on transcriptomic profiling in solid tumors. Her academic credentials are solid and her publication record is respectable within her subfield.

2. Candidate 3: Dr. Tobias Engström, PhD. Dr. Tobias Engström is an independent consultant and former Director of Bioinformatics at a major academic medical center. He holds a PhD in computational genomics and has a strong publication record of approximately fifty papers in genomic diagnostics, including several papers on ensemble methods in gene expression analysis. His technical qualifications are substantial, and

III. Damages Expert — Requirements and Evaluation Criteria A. Scope of Damages Expert's Anticipated Opinions The damages expert retained by GenomeDx will be expected to provide comprehensive opinions quantifying the damages suffered by GenomeDx as a result of Helios's infringement of the asserted patents. The anticipated scope of the damages expert's opinions encompasses the following areas: Lost-Profits Analysis. Ge

1. Academic Credentials. An advanced degree (PhD preferred) in economics, finance, or a closely related quantitative field.

2. Patent Damages Expertise. Extensive experience in patent damages analysis, with particular depth in the life sciences and diagnostics sector. The candidate must be thoroughly familiar with the Georgia-Pacific framework, the Panduit factors for lost-profits analysis, comparable-license analysis, apportionment principles, and other methodologies commonly employed in patent damages cases.

3. Industry Knowledge. Familiarity with the economics of the molecular diagnostics industry, including Medicare reimbursement structures (particularly the MolDX program and MAAA codes), laboratory-developed test (LDT) market dynamics, and the competitive landscape for genomic testing products.

4. Publication and Speaking Record. A strong record of publications and conference presentations in the area of patent damages and intellectual property economics, demonstrating thought leadership and peer recognition.

5. Litigation Experience. Prior testimony as a damages expert in federal patent cases, with a demonstrable track record of Daubert admissibility and persuasive performance at trial.

6. Absence of Conflicts. No conflicts of interest with Helios, Corinth Ventures Fund III, LP, or Ridgecrest Durneval LLP. C. Candidate 1 (Recommended): Dr. Louise Tremaine, PhD

1. Background and Qualifications. Dr. Louise Tremaine is a Managing Director at Ashworth Economics Group LLC, a leading economics consulting firm based in Chicago, Illinois, that specializes in intellectual property litigation support and damages analysis. Dr. Tremaine received her PhD in economics from the University of Chicago, with a specialization in industrial organization and intellectual property valuation. Dr

2. Prior Testimony and Litigation Experience. Dr. Tremaine has testified as a damages expert in more than twenty federal patent cases across a wide range of technologies and industries, with a concentration in life sciences, diagnostics, and medical devices. Her testimony has been consistently admitted under Daubert, and she has never had testimony or an expert report excluded by a court. Notably, Dr. Tremaine has se

3. Relevance to This Matter. Dr. Tremaine is well-positioned to provide credible and persuasive damages opinions in this matter for several reasons. First, she can credibly quantify both lost-profits and reasonable-royalty damages using GenomeDx's financial data. GenomeDx's fiscal year 2024 revenue was $387.6 million, with EBITDA of $54.3 million (a 14.0% EBITDA margin) and an average reimbursement of $4,210 per Deci

4. Conflict Check. We have conducted a thorough conflict check on Dr. Tremaine and Ashworth Economics Group LLC, with the following results: • Dr. Tremaine has no prior engagement by or on behalf of Helios Precision Diagnostics, Inc., Corinth Ventures Fund III, LP, Aether Life Sciences Partners, or Ridgecrest Durneval LLP. • Dr. Tremaine has no financial interest in GenomeDx, Pinnacle Biosciences Capital, LP, or any

5. Daubert Considerations. Dr. Tremaine presents the strongest possible Daubert profile among the candidates evaluated. Her extensive track record — more than twenty federal patent damages engagements, with no instances of exclusion — provides powerful evidence that her methodologies are reliable and that her qualifications are sufficient to support the opinions she will be asked to render. The methodologies she empl

1. Candidate 2: Dr. Richard Halstead, PhD. Dr. Richard Halstead is a Principal at Centennial Valuation Partners LLC in New York, New York. He holds a PhD in finance and has strong quantitative credentials, with particular expertise in financial modeling and valuation. Dr. Halstead has served as a patent damages expert in approximately ten prior engagements. However, the substantial majority of Dr. Halstead's patent d

2. Candidate 3: Dr. Karen Nussbaum, PhD. Dr. Karen Nussbaum is an independent economics consultant based in Washington, DC, with extensive experience in life sciences patent damages. She has served as a damages expert in approximately fifteen prior matters, many of which involved pharmaceutical, biotechnology, or diagnostics patents. Her qualifications and industry experience are comparable to Dr. Tremaine's, and she

IV. Engagement Structure and Logistics A. Retention Terms Both recommended experts — Dr. Franklin Ogawa (technical) and Dr. Louise Tremaine (damages) — will be retained through Calderwood & Harkness LLP on behalf of GenomeDx. Standard expert engagement letters are being drafted for each expert and will be circulated for review promptly upon approval of the expert selections. Separate draft engagement letters are bein

V. Recommendation and Next Steps Based on the evaluation set forth above, I recommend retaining Dr. Franklin Ogawa as GenomeDx's technical expert and Dr. Louise Tremaine as GenomeDx's damages expert. Both experts possess the qualifications, experience, and availability required to provide high-quality expert opinions and testimony in this matter, and both present strong Daubert profiles with minimal conflict risk. Su

1. Finalize and circulate draft engagement letters to both Dr. Ogawa and Dr. Tremaine for their review and comment. The engagement letters will address scope of engagement, hourly rates, billing procedures, confidentiality obligations, and Protective Order compliance.

2. Conduct final conflict confirmations with both experts' organizations. Although our preliminary conflict checks have not identified any disqualifying conflicts, we should obtain formal written confirmations from Dr. Ogawa's office at Stanford and from Ashworth Economics Group LLC prior to execution of the engagement letters.

3. Obtain client approval from Victoria Sung, General Counsel of GenomeDx, for the retention of both experts, including approval of the estimated fee range. If required by the board governance provisions applicable to litigation expenditures of this magnitude, we should also inform Jonathan Hargrove at Pinnacle Biosciences Capital, LP, of the expert selections and associated costs.

4. Execute engagement letters and onboard both experts under the Protective Order. Each expert will be required to execute the Protective Order undertaking and will receive access credentials for the RevealIQ document review platform.

5. Provide initial document packages to both experts, including the curated collections of key documents described in Section IV.C above. Priority should be given to documents that are currently available, with supplemental productions to follow as additional discovery materials are produced or become available.

6. Schedule introductory calls with both experts. The introductory call with Dr. Ogawa should cover GenomeDx's infringement theories, the key claim construction disputes, the validity challenges raised by Helios, and the prosecution history issues that will inform Dr. Ogawa's opinions. The introductory call with Dr. Tremaine should cover the damages framework (lost profits and reasonable royalty), the available finan

7. Coordinate with Wendy Schultz on the privilege review protocol to ensure that all expert communications — including draft reports, preliminary analyses, and attorney-expert communications — are properly protected under the work-product doctrine and, where applicable, the attorney-client privilege. This coordination is particularly important in light of the Federal Circuit's holding in In re Seagate Technology, LLC