Contract analysis

From: Miriam Calloway <mcalloway@calderwoodharkness.com> To: Theresa Nakamura <tnakamura@genomedx.com> Cc: Kevin Driscoll <kdriscoll@genomedx.com> Date: Fri, 10 May 2024 04:47:00 -0000 Subject: OncoPrecise GXP-47 — NCD Feasibility Assessment Memorandum [C&H Matter No. 1043-00002]

I hope this finds you well. I am copying Dr. Raval given the strategic significance of the NCD pathway analysis to GenomeDx Therapeutics' broader commercialization planning for OncoPrecise GXP-47.

Attached please find our NCD Feasibility Assessment Memorandum (dated today), prepared by Joel Strauss and me, analyzing the feasibility and projected timeline for pursuing a national coverage determination through CMS for OncoPrecise GXP-47. This deliverable was contemplated in our original engagement scope and is intended to complement the LCD/MolDx strategy work previously delivered — specifically, the Revised LCD

I want to highlight several key conclusions from the memorandum:

1. **NCD Timeline Estimate.** Based on our analysis of CMS's historical NCD processing timelines and the current regulatory environment for molecular diagnostic tests, we estimate an NCD timeline of approximately 18 to 24 months from the date of LCD issuance by Cascade Fiscal Intermediaries. This means that even under the most optimistic scenario — assuming LCD issuance occurs in late 2025 or early 2026 following the

2. **Coverage with Evidence Development (CED).** The memorandum analyzes CMS's CED framework as a potential pathway that could allow Medicare coverage while additional clinical evidence is being developed. This pathway is potentially relevant given the CLARITY-LUNG interim results, where positive predictive value came in at 0.68 versus the pre-specified target of ≥ 0.75 and negative predictive value at 0.71 versus th

3. **Traditional NCD Pathway.** We also evaluate the traditional NCD pathway through a formal request to CMS's Coverage and Analysis Group. This pathway requires a more robust evidentiary base than the current CLARITY-LUNG data supports and would benefit considerably from final trial results demonstrating clinical validity and utility at or above the pre-specified performance thresholds.

4. **Recommendation — LCD First.** Our primary recommendation is to pursue the LCD through Cascade Fiscal Intermediaries — with technical assessment through Ridgeline Administrative Services under the MolDx program — as the first-priority coverage pathway, and to defer initiation of a formal NCD request until after an LCD is in place and GDT has accumulated real-world utilization data and additional clinical evidence

A few additional notes for context. First, the memorandum's analysis should be read in conjunction with the Clinical Evidence Gap Analysis (delivered April 15) and the Revised LCD/MolDx Strategy Memorandum (delivered April 22), which recommended deferring the LCD filing until final CLARITY-LUNG data is available. Second, the NCD analysis has implications for the revenue projections previously modeled. As you will rec

I would be happy to schedule a call with you, Kevin, and Dr. Raval to walk through the memorandum's conclusions in detail and discuss how the NCD pathway fits into GDT's overall coverage strategy and commercialization timeline. I am aware that the board is continuing to evaluate the path forward for OncoPrecise GXP-47 in light of the CLARITY-LUNG interim data, and we remain fully available to support whatever directi

Please let me know what times work well for you next week, and we will coordinate from our end.

Miriam Calloway Partner, Healthcare & Life Sciences Practice Calderwood & Harkness LLP 1700 K Street NW, Suite 900 Washington, DC 20006 (202) 555-4183 mcalloway@calderwoodharkness.com