Contract analysis

I. EXECUTIVE SUMMARY This memorandum assesses the feasibility, strategic value, and projected timeline for pursuing a national coverage determination ("NCD") through the Centers for Medicare & Medicaid Services ("CMS") for Genome Dx Therapeutics Inc.'s ("GDT") OncoPrecise GXP-47, a 47-gene RNA expression panel designed to predict therapy response in patients with Stage IIIB/IV non-small-cell lung cancer ("NSCLC"). Th

II. BACKGROUND A. OncoPrecise GXP-47 — Test Overview OncoPrecise GXP-47 is a laboratory-developed test ("LDT") performed exclusively at GDT's reference laboratory, which is certified by the Clinical Laboratory Improvement Amendments ("CLIA") program under CLIA Certificate No. 05D2187432 and accredited by the College of American Pathologists ("CAP") under CAP Accreditation No. 9074821. The laboratory is located at 472

III. NCD PATHWAY OVERVIEW A. Statutory and Regulatory Framework The legal authority for national coverage determinations derives from Section 1862(a)(1)(A) of the Social Security Act, 42 U.S.C. § 1395y(a)(1)(A), which provides that Medicare will not pay for items or services that "are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body mem

IV. FEASIBILITY ANALYSIS A. Evidentiary Readiness for NCD An accurate assessment of GDT's evidentiary readiness for an NCD request requires a candid evaluation of the current evidence base supporting OncoPrecise GXP-47, the gaps in that evidence base, and the prospects for closing those gaps within a timeframe that supports NCD pursuit. Current Evidence Base. GDT's existing evidence base for OncoPrecise GXP-47 consis

1. LCD-First Strategy (Recommended). Under this approach, GDT would pursue an LCD through CFI under the MolDx program as its initial coverage objective. Once the LCD is obtained and GXP-47 has established a coverage track record within Jurisdiction E (California), GDT would use the LCD as a foundation and springboard for an NCD request to CMS. This is the approach that Calderwood & Harkness recommends, for the follow

2. Parallel LCD/NCD Strategy. Under this approach, GDT would file the LCD application with CFI and the MolDx technical assessment submission with Ridgeline while simultaneously submitting an NCD request to CMS. The intent would be to pursue both coverage pathways concurrently, potentially accelerating the timeline to national coverage. Advantages: (a) Potential timeline acceleration. If both the LCD and NCD proceedin

3. NCD-Only Strategy (Bypass LCD). Under this approach, GDT would forego the LCD application entirely and file an NCD request directly with CMS, seeking national coverage without first obtaining local coverage. Advantages: (a) Immediate national scope. If successful, an NCD would provide immediate nationwide Medicare coverage, avoiding the jurisdiction-by-jurisdiction LCD process entirely. (b) Administrative simplici

V. STRATEGIC CONSIDERATIONS A. Impact on Revenue Projections and Commercial Strategy The choice between LCD-only coverage and NCD national coverage has profound implications for GDT's revenue projections and commercial strategy. As noted in Section II.D above, the revenue projections modeled by GDT and Verdant Life Sciences Capital, LLC, assume nationwide Medicare coverage. Without NCD coverage, GDT's Medicare revenu