Contract analysis

I. Introduction and Purpose Genome Dx Therapeutics Inc. ("GDT"), a Delaware corporation headquartered in San Diego, California, respectfully submits this letter and the enclosed application materials in support of its request for the assignment of a Proprietary Laboratory Analyses ("PLA") code for its novel molecular diagnostic test, OncoPrecise GXP-47. This application is submitted for consideration at the AMA CPT E

II. Description of OncoPrecise GXP-47 A. Test Overview OncoPrecise GXP-47 is a 47-gene RNA expression panel that utilizes next-generation sequencing ("NGS") technology to measure the expression levels of 47 carefully selected genes associated with immune response, tumor microenvironment characteristics, and chemotherapy sensitivity in non-small-cell lung cancer. The test is performed on formalin-fixed, paraffin-embed

III. Proposed PLA Code Descriptor GDT respectfully proposes the following PLA code descriptor for OncoPrecise GXP-47: "OncoPrecise GXP-47 (Genome Dx Therapeutics Inc.), genomic profiling, non-small-cell lung cancer, 47-gene RNA expression panel, formalin-fixed paraffin-embedded tissue, algorithm-derived Therapy Response Index (TRI) score." The proposed descriptor has been developed in strict accordance with AMA PLA c

IV. Rationale for a PLA Code GDT submits that a PLA code is the appropriate coding mechanism for OncoPrecise GXP-47, and that the test is not adequately described by any existing CPT Category I, Category II, or Category III code, including the Genomic Sequencing Procedures ("GSP") codes and Multianalyte Assays with Algorithmic Analyses ("MAAA") codes currently in the CPT code set. In particular, GDT has considered wh

1. Proprietary Algorithmic Output: OncoPrecise GXP-47 is not merely a multi-gene sequencing panel; rather, its core clinical value lies in the generation of the proprietary Therapy Response Index (TRI) score, a composite, algorithm-derived numerical output that integrates weighted expression data from all 47 genes into a single clinically actionable metric. The TRI algorithm is unique to GDT's platform and is not rep

2. Unique Clinical Application: The intended clinical use of OncoPrecise GXP-47 — specifically, the prediction of immune checkpoint inhibitor therapy response in Stage IIIB/IV NSCLC patients to guide first-line treatment selection — is distinct from the broader analytic processes described by existing Category I GSP codes. OncoPrecise GXP-47 was designed, validated, and is marketed exclusively for this specific clini

3. Gene Count: OncoPrecise GXP-47 interrogates 47 genes, which falls below the ≥ 51 gene threshold for CPT Code 81455 and above the 5–50 gene range for CPT Code 81450. Moreover, both of these codes describe DNA and/or RNA sequence analysis without reference to the type of proprietary algorithmic interpretation that defines the OncoPrecise GXP-47 test output. 4. intellectual Property Protection: The proprietary nature

V. Analytical Validation Analytical validation of OncoPrecise GXP-47 was completed in December 2022 and was documented in a peer-reviewed publication in the Journal of Molecular Oncology Diagnostics, Volume 18, Issue 4, pages 412–429, December 2022 (the "Analytical Validation Publication"). A copy of the Analytical Validation Publication is enclosed with this application as part of the supporting documentation packag

VI. Clinical Validation GDT has initiated a prospective, multi-site, blinded clinical validation study to evaluate the clinical performance of OncoPrecise GXP-47 in predicting response to first-line immune checkpoint inhibitor therapy in patients with newly diagnosed Stage IIIB/IV NSCLC. The study, known as the CLARITY-LUNG trial, is registered on ClinicalTrials.gov under Identifier NCT05891247. The CLARITY-LUNG tria

VII. Laboratory Information For the convenience of the Panel, GDT's laboratory information is summarized as follows: GDT's laboratory has been CLIA-certified and continuously operational since March 15, 2019. The laboratory maintains full compliance with all applicable CLIA regulations (42 C.F.R. Part 493), CAP accreditation standards, and California Department of Public Health clinical laboratory licensing requireme

VIII. Existing GDT Commercial Test To provide the Panel with additional context regarding GDT's operational track record and established presence as a clinical molecular diagnostics laboratory, GDT notes that it currently offers one commercially available test: OncoPrecise GXP-12, a 12-gene expression panel for early-stage breast cancer prognosis. OncoPrecise GXP-12 was commercially launched in Q2 2021 and is current

IX. Enclosed Application Materials The following documents are enclosed with this cover letter in support of GDT's PLA code application:

1. Completed PLA Code Application Form, fully executed by authorized GDT representatives;

2. Proposed PLA code descriptor for OncoPrecise GXP-47, as set forth in Section III of this letter;

3. Detailed test methodology description and technical specifications, including sequencing platform, hybrid-capture enrichment chemistry, bioinformatics pipeline, and TRI algorithm overview;

4. Clinical indication and intended use statement, specifying the test's application in Stage IIIB/IV NSCLC for immune checkpoint inhibitor therapy response prediction;

5. Specimen type specification, documenting FFPE tumor tissue requirements, minimum input criteria, and specimen handling and transport instructions;

6. Copy of the analytical validation publication: Journal of Molecular Oncology Diagnostics, Volume 18, Issue 4, pages 412–429, December 2022;

7. CLARITY-LUNG trial summary, study protocol synopsis, and ClinicalTrials.gov registration documentation (NCT05891247);

8. Copies of GDT's CLIA certificate, CAP accreditation documentation, and California clinical laboratory license; and

9. Supporting bibliography, including citations and abstracts for prior retrospective studies supporting the biological rationale and preliminary clinical performance of the 47-gene panel and TRI algorithm.

X. Contact Information for Correspondence GDT respectfully requests that all correspondence regarding this PLA code application be directed to the following individuals: Primary Contact: Kevin Driscoll Vice President, Market Access & Reimbursement Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130 Tel: [___] Email: [___] Regulatory and Legal Contact: Theresa Nakamura General Counsel & V

XI. Closing GDT sincerely appreciates the CPT Editorial Panel's time and consideration in reviewing this application for the assignment of a PLA code for OncoPrecise GXP-47. GDT believes that OncoPrecise GXP-47 represents a meaningful clinical advance in the personalization of first-line treatment for patients with advanced non-small-cell lung cancer, and that the assignment of a unique PLA code will facilitate appro