Contract analysis

I. Executive Summary The purpose of this memorandum is to analyze and recommend Medicare reimbursement rate positioning for OncoPrecise GXP-47 ("GXP-47"), Genome Dx Therapeutics Inc.'s ("GDT") 47-gene RNA expression panel designed for use in patients with Stage IIIB/IV non-small-cell lung cancer ("NSCLC"). As described in greater detail below, rate determination for a new test assigned a Proprietary Laboratory Analys

II. Background A. OncoPrecise GXP-47 Test Overview OncoPrecise GXP-47 is a laboratory-developed test ("LDT") performed exclusively at GDT's CLIA-certified, CAP-accredited reference laboratory located in San Diego, California. The laboratory operates under CLIA Certificate Number 05D2187432, CAP Accreditation Number 9074821, and is enrolled in the National Provider Identifier system under NPI 1902847365. As an LDT, GX

III. Medicare Reimbursement Rate-Setting Framework This section provides an overview of the statutory and regulatory framework governing Medicare reimbursement rate-setting for clinical laboratory tests, with particular emphasis on the crosswalk and gapfill methodologies applicable to new tests receiving PLA codes. A. Clinical Laboratory Fee Schedule (CLFS) — Statutory and Regulatory Overview Medicare reimburses clin

1. The applicant submits a crosswalk recommendation to CMS or the applicable MAC/MolDx program, identifying proposed comparator test(s) and providing a detailed rationale for why each comparator is analogous.

2. CMS or the MAC/MolDx program evaluates the proposed crosswalk comparators, considering the technical similarity, clinical application, resources required, and other relevant factors.

3. CMS or the MAC/MolDx program may accept the proposed crosswalk, modify it (e.g., by selecting a different comparator or adjusting the rate), or reject it in favor of the gapfill methodology.

4. A public comment period may be provided, during which interested stakeholders may submit comments on the proposed crosswalk determination.

5. The final crosswalk rate is established and becomes effective on the applicable quarterly effective date. Advantages of the Crosswalk Methodology. The crosswalk approach offers several significant strategic advantages to GDT: • Predictability. Because the crosswalk rate is derived from an existing, publicly available CLFS rate, the applicant can develop a reasonably accurate estimate of the expected reimbursement

IV. Crosswalk Comparator Analysis A. Comparator Selection Methodology The selection of appropriate crosswalk comparators is a critical component of the rate-setting strategy. We applied the following criteria in identifying candidate comparators:

1. Similar Assay Technology. The comparator should employ NGS-based genomic profiling technology, consistent with GXP-47's methodology.

2. Comparable Gene Panel Size. The comparator should involve a gene panel of similar scope and complexity to GXP-47's 47-gene panel.

3. Similar Specimen Type. The comparator should use FFPE tissue specimens, consistent with GXP-47's input requirements.

4. Oncology Clinical Application. The comparator should be used in a clinical oncology context, consistent with GXP-47's intended use in NSCLC treatment decision-making.

5. Existing CLFS Rate. The comparator must have an established rate on the current CLFS to serve as a meaningful pricing reference. We conducted a systematic review of all PLA codes and Category I CPT codes for molecular diagnostic oncology tests currently listed on the CLFS. This review encompassed approximately 85 PLA codes and 45 Category I CPT codes in the molecular diagnostics and genomic profiling categories. F

V. Gapfill Alternative Analysis A. Gapfill Scenario Overview Although we strongly recommend the crosswalk methodology as the primary pricing strategy for GXP-47, we have prepared an alternative analysis under the gapfill methodology to ensure that GDT is positioned to respond in the event that CMS, the applicable MAC, or the MolDx program determines that the proposed crosswalk comparators are insufficiently analogous

1. Higher Expected Rate. The crosswalk target of $3,850 exceeds the estimated gapfill range of $2,800–$3,400, representing materially higher per-test revenue for GDT.

2. Greater Rate Predictability. The crosswalk methodology allows GDT to predict the likely reimbursement rate with reasonable accuracy based on the comparator rates, whereas the gapfill methodology introduces significant uncertainty and variability.

3. Faster Rate Certainty. The crosswalk methodology typically yields a final rate more quickly than the two-year gapfill process, enabling GDT to achieve revenue certainty sooner after PLA code assignment.

4. Ability to Advocate. The crosswalk methodology provides GDT with the opportunity to affirmatively propose comparators, present supporting rationale, and argue for a premium — tools that are not available under the MAC-driven gapfill process. Notwithstanding this recommendation, we advise that GDT maintain gapfill as a backup position and prepare the necessary cost data for submission in the event that crosswalk is

VI. Revenue Projection Implications A. Revenue Model Assumptions The revenue projections presented in this section were developed by Verdant Life Sciences Capital, LLC ("Verdant"), under the direction of Christine Lau, Managing Director, and reviewed by Calderwood & Harkness for accuracy of the Medicare reimbursement rate assumptions. The projections are based on GDT management's assumptions regarding test volume ram

VII. Comparison with Existing OncoPrecise GXP-12 Reimbursement GDT's existing commercial product, OncoPrecise GXP-12, provides a relevant reference point for the GXP-47 reimbursement rate strategy. GXP-12 is a 12-gene expression panel used in early-stage breast cancer prognosis, performed at GDT's San Diego reference laboratory. GXP-12 generates a recurrence risk score that assists oncologists in determining whether

VIII. Risk Factors and Considerations A. Clinical Evidence Risk The most significant risk factor affecting the GXP-47 reimbursement rate strategy is the status of the clinical evidence supporting the test's clinical validity and utility. As noted in Section II.A, the CLARITY-LUNG trial interim analysis released March 29, 2024 reported a positive predictive value (PPV) of 0.68 and a negative predictive value (NPV) of