Contract analysis

Section 1: Application Cover Letter Summary March 22, 2024 American Medical Association CPT Editorial Panel — PLA Code Application 330 N. Wabash Avenue, Suite 39300 Chicago, IL 60611-5885 Re: Proprietary Laboratory Analyses (PLA) Code Application — OncoPrecise GXP-47 Dear Members of the CPT Editorial Panel: On behalf of Genome Dx Therapeutics Inc. ("GDT" or the "Applicant"), a Delaware corporation headquartered in Sa

Section 2: Proposed PLA Code Descriptor 2.1 Proposed Code Descriptor (Long) In accordance with the AMA CPT Editorial Panel's formatting and editorial requirements for PLA code descriptors, GDT proposes the following long-form code descriptor for OncoPrecise GXP-47: Proposed Long Descriptor: "OncoPrecise GXP-47 (Genome Dx Therapeutics Inc.), genomic profiling, non-small-cell lung cancer, 47-gene RNA expression panel,

Section 3: Applicant Information 3.1 Applicant Entity The following information is provided regarding the applicant entity: Company Description. Genome Dx Therapeutics Inc. ("GDT") is a clinical-stage molecular diagnostics company specializing in the development and commercialization of next-generation sequencing (NGS)-based genomic tests for oncology applications. GDT was co-founded in 2018 by Dr. Anisha Raval and D

Section 4: Laboratory Information 4.1 Performing Laboratory OncoPrecise GXP-47 is performed exclusively at a single laboratory location, which is owned and operated by Genome Dx Therapeutics Inc. The following information is provided regarding the performing laboratory: GDT's San Diego Reference Laboratory has been continuously operational since March 15, 2019, and holds a valid Certificate of Accreditation under the

Section 5: Test Description — OncoPrecise GXP-47 5.1 Test Name and Overview OncoPrecise GXP-47 is a proprietary, laboratory-developed test (LDT) that utilizes next-generation sequencing technology to perform RNA expression profiling across a panel of 47 carefully selected genes. The test is designed to generate a composite, algorithm-derived numerical score — the Therapy Response Index (TRI) — that provides clinicall

Section 6: Analytical Validation Summary 6.1 Analytical Validation Study The analytical performance characteristics of OncoPrecise GXP-47 have been established through a comprehensive analytical validation study conducted at GDT's San Diego Reference Laboratory (CLIA No. 05D2187432). The analytical validation study was completed on December 14, 2022, and the results were subsequently published in a peer-reviewed scie

Section 7: Clinical Validation Summary 7.1 CLARITY-LUNG Trial Overview The clinical validity of OncoPrecise GXP-47 is being evaluated through a prospective, multi-site clinical validation study designated CLARITY-LUNG (Clinical Assessment of RNA-Integrated Therapy Yield in Lung Cancer). The CLARITY-LUNG trial is designed to establish the clinical performance of the TRI score as a predictor of patient response to immu

Section 8: Clinical Utility 8.1 Unmet Clinical Need The management of advanced non-small-cell lung cancer has been transformed in recent years by the introduction of immune checkpoint inhibitor (ICI) therapies, which have demonstrated significant improvements in overall survival for a subset of patients. However, a major and persistent challenge in the clinical management of advanced NSCLC is the limited ability of c

Section 9: Existing Coding and Rationale for New PLA Code 9.1 Survey of Existing Codes GDT and its coding advisors have conducted a thorough survey of existing CPT Category I codes, CPT Category III codes, and assigned PLA codes to identify any existing codes that could accurately describe OncoPrecise GXP-47. The following existing codes were identified as potentially relevant comparators: CPT Code 81455 — Targeted G