Contract analysis

1. Attendees and Participant Roster The following individuals are expected to participate in the kickoff meeting. Participants joining remotely are noted below. Genome Dx Therapeutics Inc. (GDT) — Client Calderwood & Harkness LLP — Outside Counsel (Medicare Coverage & Coding) Carraway Regulatory Advisors, Inc. — Coding & Billing Consultant Larkfield Health Economics, LLC — Health Economics & Outcomes Research Consult

2. Welcome and Introductions Scheduled Time: 10:00 – 10:15 AM PST Welcome. Theresa Nakamura will open the meeting on behalf of Genome Dx Therapeutics Inc. and welcome all participants to the kickoff meeting for the OncoPrecise GXP-47 Medicare Coverage and Coding Strategy engagement. Round-Table Introductions. Each participant will provide a brief introduction, including name, organization, role, and primary responsib

3. Project Scope and Objectives Scheduled Time: 10:15 – 10:35 AM PST Review of Engagement Scope. The engagement scope, as defined in the executed engagement letter dated February 14, 2024, encompasses four principal objectives: (a) Obtain a Unique CPT/PLA Code for OncoPrecise GXP-47. Secure a test-specific Proprietary Laboratory Analyses (PLA) code from the AMA CPT Editorial Panel that will serve as the billing ident

4. Overview of OncoPrecise GXP-47 — Test Characteristics Scheduled Time: 10:35 – 11:05 AM PST 4.1 Test Description Presenters: Kevin Driscoll and Dr. Priya Sundaram OncoPrecise GXP-47 is a laboratory-developed test (LDT) performed exclusively at Genome Dx Therapeutics Inc.'s CLIA-certified, CAP-accredited reference laboratory located at 4720 Torrey Pines Road, Suite 300, San Diego, California 92130. The laboratory's

5. Clinical Validation: CLARITY-LUNG Trial Status Scheduled Time: 11:05 – 11:30 AM PST 5.1 Trial Design Presenter: Dr. Priya Sundaram The clinical validation of OncoPrecise GXP-47 is being conducted through the CLARITY-LUNG trial, a prospective, multi-site, blinded clinical validation study designed to establish the clinical validity and clinical utility of the TRI score in predicting response to first-line ICI thera

6. Coding Pathway: PLA Code vs. CPT Code Analysis Scheduled Time: 11:30 AM – 12:00 PM PST 6.1 Overview of Coding Options Presenters: Miriam Calloway, Christopher Aiken, and Janet Carraway A critical threshold determination in the engagement is the selection of the appropriate coding pathway for OncoPrecise GXP-47. The coding pathway will determine how the test is identified on Medicare and commercial payer claims, an

1. Calderwood & Harkness (Aiken, Morrissey, with Calloway oversight) to prepare a detailed Coding Strategy Memorandum analyzing the PLA code pathway, the existing CPT code pathway, and the stacking approach, with a recommended course of action. Target delivery: March 11, 2024.

2. Carraway Regulatory Advisors (Carraway) to advise on AMA CPT Editorial Panel submission formatting requirements, coding mechanics, and any recent changes to AMA submission procedures or PLA code policies that may affect the application.

3. GDT (Driscoll) to provide Calderwood & Harkness and Carraway with complete technical test methodology documentation — including specimen requirements, analytical workflow, bioinformatics pipeline, TRI algorithm description, and sample test reports — to support code descriptor drafting and the overall PLA code application.

7. LCD / MolDx Strategy Scheduled Time: 12:00 – 12:30 PM PST 7.1 Medicare Administrative Contractor: Cascade Fiscal Intermediaries, LLC Presenters: Miriam Calloway and Sean Morrissey The Medicare Administrative Contractor (MAC) with jurisdiction over GDT's CLIA-certified reference laboratory in San Diego, California is Cascade Fiscal Intermediaries, LLC (CFI), which administers Medicare Part B claims for Jurisdiction

1. Test Description and Intended Use — A detailed description of the test methodology, specimen requirements, analytical workflow, and intended clinical application.

2. Analytical Validation Data — A summary of the test's analytical performance characteristics, including sensitivity, specificity, precision, accuracy, and reproducibility.

3. Clinical Validation Data — Evidence demonstrating that the test accurately identifies, measures, or predicts the clinical condition or outcome it is intended to assess.

4. Clinical Utility Evidence — Evidence demonstrating that the test results change clinical management decisions and lead to improved patient outcomes.

5. Health Economic Analysis — Analysis of the cost-effectiveness and budget impact of the test relative to existing standard of care.

6. Supporting Bibliography — A comprehensive bibliography of peer-reviewed publications and other relevant literature supporting the test's clinical validity and utility. 7.3 LCD Application Process and Timeline The LCD application process involves the submission of a formal request letter to CFI, accompanied by the MolDx technical assessment dossier and all supporting documentation. The request letter will identify

8. Reimbursement Rate Strategy — Preliminary Discussion Scheduled Time: 12:30 – 12:45 PM PST 8.1 Target Reimbursement Rate Presenters: Sean Morrissey and Kevin Driscoll GDT's target Medicare reimbursement rate for OncoPrecise GXP-47 is $3,850 per test. This target has been developed by GDT's market access team in consultation with its financial advisors and reflects the test's clinical value, development costs, opera

9. NCD Pathway — Preliminary Overview Scheduled Time: 12:45 – 12:55 PM PST 9.1 National Coverage Determination Considerations Presenter: Miriam Calloway The overall coverage strategy for OncoPrecise GXP-47 contemplates the eventual pursuit of a National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS), following successful LCD coverage at the MAC level. An NCD would provide nationw

10. Project Timeline and Key Milestones Scheduled Time: 12:55 – 1:10 PM PST 10.1 Master Timeline Presenter: Sean Morrissey The following master timeline summarizes the key milestones and target dates for the engagement: 10.2 Milestone Dependencies and Sequencing The team will discuss the following critical dependencies and sequencing considerations: PLA Code Application Deadline. The PLA code application must be subm

11. Workstream Assignments and Responsibilities Scheduled Time: 1:10 – 1:20 PM PST 11.1 Workstream 1: Coding Strategy and PLA Code Application Lead: Christopher Aiken (Calderwood & Harkness) and Janet Carraway (Carraway Regulatory Advisors) Oversight: Miriam Calloway (Calderwood & Harkness) GDT Contacts: Kevin Driscoll, Theresa Nakamura Deliverables: • Coding Strategy Memorandum — March 11, 2024 • Draft PLA Code Appl

12. Communication Protocol and Reporting Scheduled Time: 1:20 – 1:25 PM PST The team will confirm the following communication protocol for the duration of the engagement: Biweekly Status Calls. Calderwood & Harkness and GDT (Nakamura, Driscoll) will participate in standing biweekly status calls to review project progress, discuss open issues, and coordinate upcoming deliverables. Janet Carraway (Carraway Regulatory A

13. Open Items and Next Steps Scheduled Time: 1:25 – 1:30 PM PST The following open items and next steps will be confirmed before adjournment:

1. GDT to provide Calderwood & Harkness with the complete OncoPrecise GXP-47 technical file, analytical validation data package, and CLARITY-LUNG trial protocol. Deadline: March 8, 2024.

2. GDT to provide Calderwood & Harkness with the GXP-12 LCD (L38472) file and all prior correspondence with Cascade Fiscal Intermediaries for reference purposes. Deadline: March 8, 2024.

3. Calderwood & Harkness (Aiken, Morrissey, Calloway) to deliver the Coding Strategy Memorandum analyzing PLA code versus CPT code options. Deadline: March 11, 2024.

4. Calderwood & Harkness (Morrissey) to prepare a regulatory landscape background memorandum on Medicare coverage for NGS-based oncology diagnostics, surveying current LCDs, NCDs, and MolDx program requirements relevant to the GXP-47 coverage strategy. Target delivery: Late February / Early March 2024.

5. Carraway Regulatory Advisors (Carraway) to provide AMA CPT Editorial Panel submission requirements, current PLA code application template, and any recent AMA policy updates. Deadline: March 8, 2024.

6. Larkfield Health Economics (Dr. Ostroff) to circulate a preliminary HEOR analysis scope and workplan, including data requirements, analytical framework, and projected timeline for deliverables. Deadline: March 15, 2024.

7. First biweekly status call to be scheduled for the week of March 11, 2024. Sean Morrissey will circulate a calendar invitation to all participants.

8. Meeting minutes from today's kickoff meeting will be prepared and circulated by Sean Morrissey within three (3) business days of the meeting.

14. Adjournment The meeting is expected to conclude at approximately 1:30 PM PST / 4:30 PM EST. Distribution This agenda has been distributed to the following individuals: • All attendees listed in Section 1 above • Joel Strauss, Partner, Calderwood & Harkness LLP (for information) • Dr. Anisha Raval, Co-Founder & CEO, Genome Dx Therapeutics Inc. (for information) CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED — ATTORNEY