Q301--New - CareDx Base + 4

DEPARTMENT OF VETERANS AFFAIRS Network Contracting Office 17 Notice of Intent to Sole Source | CareDx AlloMap Heart and AlloSure Heart Testing Services NOTICE OF INTENT TO SOLE SOURCE OPEN-MARKET COMMERCIAL SERVICES AlloMap Heart and AlloSure Heart Laboratory Testing Services Agency Department of Veterans Affairs Contracting Office Network Contracting Office 17 (NCO 17) Requiring Activity VA North Texas Health Care System (VANTHCS) Notice Type Special Notice Notice of Intent to Sole Source Posting Date October 5, 2026 Response Deadline October 15, 2026, at 4:00 p.m. Central Time Anticipated Award Date On or before June 2, 2027 NAICS 621511 Medical Laboratories PSC Q301 Medical Laboratory Testing Set-Aside None Place of Performance VA North Texas Health Care System, 4500 S. Lancaster Road, Dallas, TX 75216 Notice The Department of Veterans Affairs (VA), Network Contracting Office 17, intends to solicit and negotiate on a sole-source basis with CareDx, Inc., 8000 Marina Boulevard, Brisbane, California 94005, for commercial reference-laboratory testing services for the VA North Texas Health Care System. The contemplated action will be conducted as an open-market commercial-service acquisition under Revolutionary FAR Overhaul (RFO) FAR Part 12. The decision to restrict competition will be documented in accordance with RFO FAR 12.102. This notice is not a solicitation and does not constitute a request for quotations or proposals. A solicitation is not available through this notice. However, all responsible sources may submit a capability statement and, if desired, a quotation or proposal. The VA will consider each timely response before determining whether to proceed with the contemplated sole-source acquisition. Requirement The contractor shall provide AlloMap Heart and AlloSure Heart blood-testing services for Veteran heart-transplant patients. The services support noninvasive monitoring of transplant stability and potential rejection in conjunction with standard clinical assessment. Estimated annual volume: 10 AlloMap Heart tests and 10 AlloSure Heart tests. Quantities are estimates and do not guarantee a minimum number of tests. Provide all labor, testing, materials, equipment, specimen supplies, preservatives, requisition forms, special instructions, packaging guidance, and other resources necessary for performance. Provide training to VANTHCS personnel on specimen handling and packaging, and provide specimen collection through commercial laboratory or mobile-draw sites for selected assays when ordered through the contractor s portal. Perform testing within current published turnaround times and provide complete results, status support, technical consultation, and account support. Maintain all required licenses, certifications, and accreditations, including compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA), applicable laboratory-accreditation requirements, privacy requirements, and VA information-security requirements. Provide services during the anticipated base period and four option periods shown below. Performance Period Dates Base Period June 3, 2027 June 2, 2028 Option Period 1 June 3, 2028 June 2, 2029 Option Period 2 June 3, 2029 June 2, 2030 Option Period 3 June 3, 2030 June 2, 2031 Option Period 4 June 3, 2031 June 2, 2032 Basis for Intended Source CareDx, Inc. has represented in a letter dated June 10, 2026, that it is the sole-source provider of AlloMap Heart and AlloSure Heart testing services. CareDx further represented that AlloMap Heart is the only heart gene-expression testing service available on the market and that HeartCare, which combines AlloMap Heart and AlloSure Heart, is the only combined heart gene-expression and donor-derived cell-free DNA testing service available on the market. Based on the proprietary nature of the required assays and the information currently available to VA, CareDx is the only source known to be capable of satisfying the requirement without substituting different tests or methodologies. Response Requirements An interested source must submit sufficient, specific, and verifiable information demonstrating its present ability to perform the complete requirement. Marketing literature or an unsupported statement of capability is not sufficient. The response shall include: Legal business name, physical address, point of contact, telephone number, email address, Unique Entity ID, CAGE code, and business size and socioeconomic status under NAICS 621511. Evidence that the respondent can furnish and perform both AlloMap Heart and AlloSure Heart testing services, including any license, ownership right, authorization, or enforceable agreement permitting the respondent to provide the proprietary assays for the entire contemplated period of performance. A point-by-point explanation of how the respondent will satisfy the attached Statement of Work, including estimated quantities, specimen supplies, collection support, handling and shipping, published turnaround times, result reporting, technical consultation, customer support, invoicing, records management, privacy, and information-security requirements. Copies or identifying information for current CLIA certification, applicable laboratory accreditation, licenses, and other required professional credentials. Identification of the laboratory location where each assay will be performed and disclosure of all proposed subcontractors or reference laboratories. Relevant past performance demonstrating successful performance of the same or substantially similar heart-transplant molecular testing services. Identification and technical support for any proposed alternative methodology, including clinical validation and a clear explanation of how the alternative meets every functional and clinical requirement without increasing risk, delay, or burden to Veteran patients or VA clinicians. Submission Instructions Responses are due no later than October 15, 2026, at 4:00 p.m. Central Time. Submit responses electronically to the Primary Point of Contact identified in the SAM.gov notice (ognian.ivanov@va.gov), please include CareDx AlloMap/AlloSure Heart Sole-Source Notice Response in the subject line. Responses shall be in Microsoft Word or searchable PDF format and should not exceed 10 pages, excluding licenses, certifications, and supporting technical validation. Clearly mark any proprietary information. The Government will not reimburse any costs incurred in preparing or submitting a response. Submission of a response does not create any right to an award and does not obligate the Government to issue a solicitation, conduct discussions, or award a contract. Government Determination The information received will be used solely to determine whether a competitive acquisition is feasible. A determination not to compete this proposed action, based on responses to this notice, is solely within the discretion of the Government. If no timely response demonstrates that another responsible source can satisfy the complete requirement, VA intends to solicit and negotiate only with CareDx, Inc.