Donor derived cell free Deoxyribonucleic acid (DNA) testing   2

Background
The Ralph H. Johnson VA Health Care System (RHJ VA HCS) aims to enhance the health of veterans by providing comprehensive healthcare services. This contract focuses on establishing a kidney transplant program that enables monitoring for potential transplant rejection in veterans who have undergone kidney transplants. The acquisition of donor derived cell free DNA (dd-cf-DNA) testing is essential for timely clinical decision-making regarding transplant rejection.

Work Details
The contractor is required to provide clinically validated, FDA-approved donor derived cell free DNA (dd-cf-DNA) testing to assist in clinical decision-making for kidney transplant patients. Key tasks include:

1. Providing results within 3 business days from receipt via electronic delivery to the transplant team.
2. Supplying test kits that include all necessary materials for specimen collection, such as requisition forms, specimen containers, and return packaging.
3. Offering mobile phlebotomy services for remote patients to facilitate specimen collection at home or other locations.
4. Maintaining all necessary licenses, permits, certifications, and accreditations required by law to perform the testing.

Period of Performance
The contract will be executed over a five-year period, starting from August 1, 2026, and ending on July 31, 2031, with options for four additional years.

Place of Performance
Testing will be conducted at the contractor’s laboratory facility with results securely reported to the RHJ VA HCS Kidney Transplant Team. Blood samples may be collected at a VA laboratory or through mobile phlebotomy in patients' homes.

Bidder Requirements
Bidders must meet the following requirements:

- Small Business Set Aside - Total (SBA).
- Must possess clinically validated and FDA-approved dd-cf-DNA testing capabilities.
- Must have the ability to provide timely results and mobile phlebotomy services.
- Must maintain all necessary licenses and certifications required by law.

Incumbent Analysis (see Incumbents section for more detail)
This opportunity appears to have a confirmed incumbent and/or closely related prior contract based on award 36C25221D0074, awarded to Caredx for approximately $9,554,100 (09/30/21–09/29/26). The prior work involved providing AlloSure kidney donor-derived cell-free DNA testing for renal transplant patients, including specimen collection kits and performing the dd-cf-DNA test with results delivered within about 72 hours. The current requirement similarly calls for clinically validated, FDA-approved donor derived cell free DNA testing for kidney transplant rejection monitoring, with kit supply and timely electronic reporting, indicating continuity of the same type of diagnostic service.