Contract analysis

I. Executive Summary This memorandum is prepared at the direction of the Board of Directors of Genome Dx Therapeutics Inc. ("GDT" or the "Company") following its meeting on April 9, 2024, at which the Board requested that Calderwood & Harkness LLP ("Calderwood & Harkness" or "the Firm") reassess the Local Coverage Determination ("LCD") filing strategy for the Company's OncoPrecise GXP-47 diagnostic test ("GXP-47") in

II. Background A. OncoPrecise GXP-47 Test Overview OncoPrecise GXP-47 is a proprietary 47-gene RNA expression panel designed to guide oncologist decision-making regarding the selection of first-line systemic therapy in patients with advanced non-small-cell lung cancer ("NSCLC"). The test is performed on formalin-fixed, paraffin-embedded ("FFPE") tumor tissue specimens obtained from biopsy or surgical resection of NSC

1. PLA Code Application (June 28, 2024 submission deadline): Submit a Proprietary Laboratory Analyses ("PLA") code application to the American Medical Association ("AMA") CPT Editorial Panel, targeting review at the September 2024 Editorial Panel meeting. The PLA code would provide a unique identifier for GXP-47 on the Medicare Clinical Laboratory Fee Schedule and facilitate accurate claims submission and reimburseme

2. LCD Request and MolDx Dossier Submission (August 2024): Following PLA code assignment (or with the application pending), file a formal LCD request with CFI for Jurisdiction E, accompanied by a comprehensive MolDx technical assessment dossier submitted to RAS. The August 2024 target was selected to allow submission of the PLA code application before the LCD filing, and to provide sufficient time for dossier prepara

3. National Coverage Determination (Estimated 18–24 Months Post-LCD): Upon successful issuance of a favorable LCD by CFI, pursue an NCD through the Centers for Medicare & Medicaid Services ("CMS") to secure national Medicare coverage. The estimated NCD timeline of 18 to 24 months from LCD issuance was based on historical processing times for comparable molecular diagnostic tests. In furtherance of this strategy, Cald

III. Analysis of Current Clinical Evidence Package A. Evidence Required for LCD/MolDx Coverage The MolDx program, administered by RAS under the direction of Dr. Catherine Embry, MolDx Technical Assessment Director, serves as the primary technical assessment framework through which Medicare evaluates the analytical validity, clinical validity, and clinical utility of molecular diagnostic tests. CFI, as the MAC for Jur

1. Analytical Validity: Demonstration that the test reliably and accurately measures the analytes it is designed to measure, including precision, reproducibility, analytical sensitivity, analytical specificity, and interfering substances.

2. Clinical Validity: Demonstration that the test result (in this case, the TRI score) is reliably associated with the clinical outcome of interest (in this case, response to ICI therapy as measured by 12-month PFS).

3. Clinical Utility: Demonstration that the use of the test result in clinical decision-making leads to improved patient outcomes relative to the standard of care without the test. This may include direct evidence of outcome improvement, decision-impact studies, or well-reasoned clinical modeling. Within the MolDx evidence hierarchy, prospective clinical validation studies carry the greatest evidentiary weight. Prosp

IV. Risks of Premature LCD Filing A. Risk of Non-Coverage Determination Based on our analysis of the current evidence package, our experience with the MolDx program and the CFI LCD process, and our review of analogous coverage determinations for molecular diagnostic tests in oncology, we assess that the most probable outcome of an LCD request and MolDx dossier submission based on the current evidence package would be

V. Alternative Timeline Scenarios A. Scenario 1: Immediate Filing (Original August 2024 Timeline) — Not Recommended Under this scenario, GDT would proceed with the original timeline and file the LCD request with CFI and submit the MolDx technical assessment dossier to RAS in August 2024. The filing would be based on the CLARITY-LUNG interim analysis data (PPV 0.68, NPV 0.71), supplemented by the prior retrospective v

VI. Impact on Related Workstreams A. PLA Code Application As noted above, the June 28, 2024 submission deadline for the AMA CPT Editorial Panel September 2024 meeting will not be met under the recommended Scenario 2 timeline. The deferral of the LCD filing necessarily affects the PLA code submission timeline, as the practical value of obtaining a PLA code before a coverage determination is limited — the PLA code faci

VII. Recommendations and Proposed Next Steps A. Primary Recommendation Based on the analysis set forth in this memorandum and in the Gap Analysis Memorandum of April 15, 2024, Calderwood & Harkness recommends the following:

1. Defer the LCD request filing with CFI and the MolDx technical assessment dossier submission to RAS until final CLARITY-LUNG trial data is available, currently projected for Q2 2025.

2. Target a revised LCD filing window of Q3/Q4 2025, allowing approximately two to three months after the CLARITY-LUNG final data readout for data analysis, peer-reviewed manuscript preparation, and dossier finalization.

3. Defer the PLA code application submission from the June 28, 2024 AMA CPT Editorial Panel deadline to a future Editorial Panel meeting aligned with the revised coverage timeline, likely targeting Q3 2025. This recommendation reflects our judgment that the risks of premature filing — principally the high probability of a non-coverage determination and the creation of lasting adverse precedent — substantially outweig

1. Complete and deliver the draft MolDx Technical Assessment Dossier (Version 1.0) by April 30, 2024, as a preserved work product that can be updated with final clinical data when available.

2. Complete the reimbursement rate crosswalk/gapfill analysis (preliminary results expected mid-May 2024), to preserve the analytical work product and inform future rate positioning decisions.

3. Complete the NCD Feasibility Assessment (expected delivery May 10, 2024), to provide GDT with a comprehensive assessment of the NCD pathway and timeline that can be updated as the coverage strategy evolves.

4. Explore Scenario 3 (informal MolDx pre-assessment with RAS) as a complement to the recommended deferral strategy. Calderwood & Harkness will advise on the process for initiating informal engagement with Dr. Catherine Embry and prepare an outreach strategy and tailored evidence summary if GDT elects to pursue this approach.

5. Coordinate with Whitford & Sable LLP (Harrison Whitford, Lead Partner; Danielle Reeves, Associate) on corporate governance and board communication aspects of the revised strategy. Whitford & Sable serves as GDT's primary outside corporate counsel and should be apprised of the revised timeline and its implications for board obligations, investor communications, and corporate governance matters.

6. Analyze the PCNB Revolving Facility milestone covenant implications. Calderwood & Harkness will prepare a separate memorandum addressing whether the existing LCD for OncoPrecise GXP-12 (LCD L38472, effective August 15, 2021, issued by CFI) satisfies the milestone covenant language in Section 7.14 of the Revolving Credit Agreement (Reference No. PCNB-GDT-RF-2023-0922), and identifying options for addressing a poten

7. Advise Larkfield Health Economics, LLC (Dr. Nathan Ostroff) and Carraway Regulatory Advisors (Janet Carraway, Principal) of the revised timeline and instruct them to preserve their respective work products for incorporation into the final dossier and regulatory filings when the coverage strategy is reactivated. C. Board Communication Calderwood & Harkness is prepared to present this analysis and recommendation to