Contract analysis

I. EXECUTIVE SUMMARY The purpose of this memorandum is to analyze whether Genome Dx Therapeutics Inc. ("GDT") should bill its forthcoming OncoPrecise GXP-47 laboratory-developed test under an existing Current Procedural Terminology ("CPT") code — primarily CPT 81455 (genomic sequencing, solid organ neoplasm, 51 or more genes) or a combination of stacked existing codes — or whether GDT should instead pursue assignment

II. BACKGROUND A. Overview of OncoPrecise GXP-47 OncoPrecise GXP-47 is a laboratory-developed test ("LDT") designed and performed exclusively at GDT's CLIA-certified, CAP-accredited reference laboratory located at 4720 Torrey Pines Road, Suite 300, San Diego, California 92130. The laboratory operates under CLIA Certificate Number 05D2187432 and holds accreditation from the College of American Pathologists under CAP N

III. ANALYSIS OF EXISTING CPT CODE OPTIONS This section evaluates the existing CPT codes and coding approaches that could potentially be used to bill for OncoPrecise GXP-47 and explains why, in each case, the existing option is inadequate. A. CPT Code 81455 — Genomic Sequencing, Solid Organ Neoplasm, 51+ Genes CPT Code 81455 is described as: "Targeted genomic sequence analysis panel, solid organ or hematolymphoid neo

IV. ANALYSIS OF PLA CODE PATHWAY A. Overview of PLA Code Category Proprietary Laboratory Analyses codes, designated within the AMA CPT code set under Section 0001U through 0XXXU, are assigned to clinical laboratory tests that meet one of two criteria: (1) the test is performed by a single ("sole-source") clinical laboratory, or (2) the test is available only from a single manufacturer. The PLA code category was estab

1. Test-Specific Reimbursement Rate A PLA code is a prerequisite to obtaining a test-specific Medicare reimbursement rate through the crosswalk or gapfill pricing process under the CLFS. Without a unique code, there is no mechanism for CMS to assign a payment rate that reflects the specific resource costs, clinical utility, and value proposition of OncoPrecise GXP-47. GDT's target reimbursement rate of $3,850 per tes

2. LCD/MolDx Coverage Pathway Alignment A unique PLA code provides CFI and Ridgeline (MolDx) with a specific, unambiguous billing code to reference in the LCD for OncoPrecise GXP-47. This enables the MACs to establish precise coverage criteria — including patient population definitions, clinical indications, ordering physician requirements, specimen type specifications, and clinical utility standards — that are tied

3. Product Identity and Market Differentiation The PLA code descriptor will include "OncoPrecise GXP-47" and "Genome Dx Therapeutics Inc." by name. This naming convention, which is a standard feature of PLA codes, provides OncoPrecise GXP-47 with a distinct, recognizable identity in claims data, payer systems, electronic health records, laboratory ordering databases, and utilization management platforms. This identit

4. Commercial Payer Negotiations A unique PLA code facilitates negotiations with commercial payers, who increasingly require specific billing codes for coverage and contracting. Many commercial health plans will not enter into coverage agreements or negotiate reimbursement rates for tests billed under generic or unlisted codes. A PLA code provides the administrative infrastructure that commercial payers need to estab

5. Utilization Tracking and Evidence Development A dedicated PLA code enables GDT to track real-world utilization of OncoPrecise GXP-47 across the Medicare and commercial payer landscapes. Test-specific claims data, made possible by the PLA code, can be used to monitor adoption patterns, identify geographic or provider-level variations in utilization, and assess the test's penetration into the target patient populati

1. Timeline Dependency Obtaining a PLA code requires submission to and approval by the AMA CPT Editorial Panel, which introduces a timeline dependency into GDT's commercial planning. The next available submission deadline for a PLA code application is June 28, 2024, for consideration at the AMA CPT Editorial Panel's September 2024 meeting. If the code is approved at that meeting, the effective date would be approxima

2. Interim Billing Gap Until the PLA code is assigned and effective, GDT would need to bill under CPT 81479 (unlisted molecular pathology procedure) or another interim arrangement. As discussed in Section III.B above, billing under CPT 81479 results in uncertain and unpredictable reimbursement. This interim billing gap is a real but manageable risk: GDT should plan its commercial launch timeline to minimize the gap p

3. Application Effort and Cost Preparing a compliant PLA code application requires detailed documentation of the test methodology, clinical indications, specimen type, laboratory credentials, and supporting clinical evidence. This documentation effort involves time and resources from both Calderwood & Harkness and GDT's internal teams. However, this risk is substantially mitigated by the overlap between the PLA appli

4. No Guarantee of Approval While PLA code applications are generally approved by the AMA CPT Editorial Panel if the test meets the sole-source criteria and the application is complete and properly formatted, there is an inherent procedural risk that the application could be rejected or that the Panel could request additional information, resulting in a delay to the next quarterly cycle. Based on our review of recent

V. AMA CPT EDITORIAL PANEL — SUBMISSION REQUIREMENTS AND TIMELINE A. Application Components The PLA code application to the AMA CPT Editorial Panel must include the following components:

1. Completed PLA Code Application Form. The AMA provides a standardized application form for PLA code requests. The form must be completed in full, using the format specified by the AMA, and must include all required data fields.

2. Test Description and Clinical Indications. A comprehensive narrative describing the test, including its clinical purpose, intended patient population, the clinical decisions it is designed to inform, and the clinical utility it provides.

3. Specimen Type and Methodology Description. A detailed technical description of the specimen requirements (FFPE NSCLC tumor tissue), the analytical methodology (47-gene RNA expression panel via next-generation sequencing), and the algorithmic processing (TRI score computation).

4. Laboratory Information. Complete identification of the performing laboratory, including: • CLIA Certificate Number: 05D2187432 • CAP Accreditation Number: 9074821 • National Provider Identifier: 1902847365 • Laboratory Name: Genome Dx Therapeutics Inc. • Laboratory Address: 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130

5. Supporting Clinical Literature. Published clinical evidence supporting the test's analytical and clinical validity, including the analytical validation study published in the Journal of Molecular Oncology Diagnostics, Volume 18, Issue 4, pages 412–429 (December 2022). Additional supporting literature regarding the clinical utility of RNA expression profiling for ICI therapy selection in NSCLC will be included as s

6. Attestation of Sole-Source Status. A signed attestation from an authorized GDT officer confirming that OncoPrecise GXP-47 is performed exclusively at GDT's single reference laboratory and is not available as a kit, platform, or licensed technology from any other source.

7. Cover Letter. A cover letter submitted on behalf of GDT (or by GDT's authorized representative) introducing the application, summarizing the basis for the PLA code request, and identifying contact persons for AMA follow-up. B. Submission Timeline The PLA code application timeline is driven by the AMA CPT Editorial Panel's quarterly consideration cycle. The relevant dates for GDT's application are as follows: • Sub

VI. INTERACTION WITH LCD/MOLDX COVERAGE STRATEGY A. Sequencing of PLA Code and LCD Filing The coding strategy and coverage strategy for OncoPrecise GXP-47 are interdependent, and their sequencing must be carefully managed. Ideally, the PLA code assignment should precede or coincide with the LCD filing with Cascade Fiscal Intermediaries, LLC (CFI) and the MolDx technical assessment submission to Ridgeline Administrati

VII. RECOMMENDATION Based on the foregoing analysis, Calderwood & Harkness's recommendations are as follows: Primary Recommendation. GDT should pursue a PLA code for OncoPrecise GXP-47, targeting submission of the PLA code application to the AMA CPT Editorial Panel by the June 28, 2024 deadline for consideration at the September 2024 meeting. Rationale Summary. This recommendation is grounded in the following cumulat

1. Existing CPT codes are inadequate. CPT 81455 presents a gene count mismatch, a methodology mismatch, a $931/test reimbursement shortfall, coverage pathway complications, and compliance risks. CPT 81479 offers no established reimbursement rate and imposes unsustainable administrative burdens. Code stacking is disfavored by CMS and the MolDx program, creates audit risk, and does not support a clean LCD.

2. A PLA code captures the proprietary nature of GXP-47. The PLA code descriptor will identify OncoPrecise GXP-47 by name, specify the 47-gene RNA expression methodology, and describe the proprietary TRI algorithm — none of which are captured by any existing CPT code.

3. A PLA code supports a premium reimbursement rate. A test-specific PLA code is necessary for GDT to pursue a $3,850/test Medicare reimbursement rate through the crosswalk or gapfill process, supported by comparables Elara 0250U ($3,742) and Marlowe Asset Management 0239U ($4,206).

4. A PLA code aligns with the LCD/MolDx coverage pathway. A specific billing code enables CFI and Ridgeline to establish a clean, test-specific LCD for OncoPrecise GXP-47.

5. The PLA code approach is consistent with industry precedent. Comparable proprietary oncology diagnostics — Elara GeneSight Onco-48 (0250U) and Marlowe Asset Management TumorMap Pro (0239U) — have successfully obtained PLA codes and test-specific reimbursement rates through this pathway.

6. The timeline is compatible with GDT's commercial planning. The PLA code application timeline (submission by June 28, 2024; potential approval September 2024; effective Q1 2025) aligns with GDT's commercial launch planning and the anticipated CLARITY-LUNG trial data readout timeline. Alternative/Fallback Strategy. If the PLA code application cannot be submitted by the June 28, 2024 deadline, or if the AMA CPT Edito

VIII. NEXT STEPS AND ACTION ITEMS The following table sets forth the immediate action items, responsible parties, and target dates for the PLA code application and related workstreams: We will schedule a working call with Theresa Nakamura, Kevin Driscoll, and Janet Carraway during the week of March 18, 2024 to confirm the action plan, discuss any questions regarding this memorandum, and initiate the draft PLA applica

IX. QUALIFICATIONS AND LIMITATIONS This memorandum constitutes legal advice provided by Calderwood & Harkness LLP to Genome Dx Therapeutics Inc. in connection with Matter No. 1043-00002 and is protected by the attorney-client privilege. This memorandum is intended solely for the use of the named recipients and other authorized personnel of Genome Dx Therapeutics Inc. and should not be disclosed to third parties witho