Extract to table

CRITICAL OBSERVATIONS AND AREAS REQUIRING REVISION Our review of the Larkfield HEOR deliverables has identified several significant issues that must be addressed before the analysis can be incorporated into the MolDx Technical Assessment Dossier

The current draft presents the interim values as established performance characteristics rather than as interim estimates subject to revision upon completion of the trial; this framing must be corrected

Compliance with Anti-Kickback Statute and Stark Law Considerations While compliance with the federal Anti-Kickback Statute ("AKS") and the Physician Self-Referral Law ("Stark Law") is not a primary focus of the HEOR analysis, we flag the following considerations for GDT's and Larkfield's awareness: Any arrangements between GDT and clinical sites participating in the CLARITY-LUNG trial — including site agreements, investigator payments, and specimen procurement arrangements — must be structured to comply with the federal AKS, 42 U

Similarly, any arrangements between GDT and referring physicians or institutions related to the commercial utilization of OncoPrecise GXP-47 must comply with these statutes

COORDINATION WITH OTHER WORKSTREAMS The Larkfield HEOR analysis must be consistent with and fully integrated into the broader MolDx Technical Assessment Dossier (Version 1