Q301--DONOR-DERIVED CELL FREE DNA TESTING

The VISN 2 Contracting Office in Albany, NY, has issued a Sources Sought Notice to gather information on Donor-Derived Cell-Free DNA (dd-cfDNA) Testing for the James J. Peters Bronx VA Medical Center, aiming to establish a new service by December 1, 2025. This notice is for market research, not contract award, and seeks to determine the viability of setting aside the requirement for specific socio-economic categories. Interested contractors, classified under NAICS Code 621511 (Medical Laboratories) and PSC Q301 (Medical – Reference Laboratory Testing), must submit a capability statement and company information, including UEI, DUNS, and socio-economic status, to Mariangie Rivera by November 14, 2025, at 10:00 AM ET. Responses should detail experience, self-performance plans, subcontracting intentions, and include a completed

The Bronx VA Medical Center requires donor-derived cell-free DNA (dd-cfDNA) testing services for its renal transplant program at the James J. Peters VA Medical Center (JJP VAMC). The contractor must provide all personnel, materials, equipment, transportation, and supervision for accurate, timely, and secure dd-cfDNA testing to monitor kidney transplant recipients for potential allograft injury or rejection. The services must deliver reliable results within 72 hours of specimen receipt, facilitate early detection of allograft injury, ensure secure data transmission, and offer clinical interpretation support and training to VA staff. All data handling must comply with VA Handbook 6500 and HIPAA, with any data breach reported within 24 hours. The contract requires a base period and four option years, with services performed daily, including holidays. The contractor must provide specimen collection kits, process them in a CLIA-certified lab, and deliver electronic results with ≥98% accuracy. The contractor will also manage kit delivery and provide training and ongoing clinical consultation. Deliverables include test reports, monthly utilization summaries, annual compliance documentation, training logs, and immediate incident reporting. The contractor must hold CLIA certification, CAP accreditation, state licenses, and comply with GLP and GCP. The contract type is IDIQ Firm Fixed Price, with the government monitoring performance via a Quality Assurance Surveillance Plan.

The Department of Veterans Affairs is seeking donor-derived cell-free DNA (dd-cfDNA) testing services for the renal transplant program at the James J. Peters VA Medical Center in Bronx, NY. This Sources Sought Notice, identified by Solicitation Number 36C24226Q0126, requests contractors to provide all necessary personnel, materials, equipment, transportation, and supervision for accurate, timely, and secure dd-cfDNA testing. The purpose of these services is to monitor kidney transplant recipients for potential allograft injury or rejection. Responses are due by November 14, 2025, at 10:00 am Eastern Time.