Contract analysis

I. Introduction and Purpose This annotated bibliography accompanies the MolDx Technical Assessment Dossier (Version 1.0) for OncoPrecise GXP-47, a proprietary 47-gene RNA expression panel laboratory-developed test ("LDT") developed, manufactured, and performed exclusively by Genome Dx Therapeutics Inc. ("GDT") at its CLIA-certified (CLIA No. 05D2187432), CAP-accredited (CAP No. 9074821) reference laboratory located a

II. Category A: Analytical Validation (Publications 1–8) Purpose: Publications in this category demonstrate the analytical performance characteristics of OncoPrecise GXP-47 and related NGS-based gene expression assay methodologies. Topics addressed include assay accuracy, precision (intra-run and inter-run), reproducibility, limit of detection, linearity, specimen handling requirements for FFPE tissue, bioinformatics

III. Category B: Clinical Validation (Publications 9–20) Purpose: Publications in this category report clinical validation data for OncoPrecise GXP-47 and analogous predictive biomarker assays for ICI therapy response in NSCLC. This category includes publications describing the design, interim results, and planned final analysis of the CLARITY-LUNG prospective clinical validation trial; retrospective validation studi

IV. Category C: Clinical Utility (Publications 21–30) Purpose: Publications in this category demonstrate the clinical utility of genomic expression-based predictive testing in guiding ICI therapy decisions in NSCLC. Clinical utility evidence addresses the question of whether test results, when communicated to clinicians, change treatment decisions in ways that improve patient outcomes, reduce adverse events, or avoid

V. Category D: Health Economics (Publications 31–37) Purpose: Publications in this category support the health economic analysis prepared by Dr. Nathan Ostroff, PhD, MS, Principal Consultant, Larkfield Health Economics, LLC, for inclusion in Section 5 (Health Economic Analysis) of the MolDx Technical Assessment Dossier. These publications address cost-effectiveness modeling, budget impact analysis, the economic burde

VI. Category E: Background Literature — ICI Therapy in NSCLC (Publications 38–43) Purpose: Publications in this category provide the foundational scientific and clinical background on immune checkpoint inhibitor therapy in advanced non-small-cell lung cancer, including the mechanisms of action of anti-PD-1, anti-PD-L1, and anti-CTLA-4 agents; approved indications and pivotal clinical trial outcomes; limitations of cu