Q301--ThyroSeq v3 Genomic Classifier Sole Source Notice

The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 10 has issued a Special Notice for a sole source procurement of the ThyroSeq v3 Genomic Classifier. The agency intends to negotiate a firm fixed price contract with CBL Path, located in Rye Brook, New York, to provide this genomic testing service for the Richard L. Roudebush VA Medical Center. The contract structure includes a base year plus four one-year option years, operating under NAICS code 621511 (Medical Laboratories) with a size standard of $41.5 million. This procurement falls under the exclusive licensing provisions of FAR 13.106-1(b)(1)(i) and is classified as reference laboratory testing services. The contracting office has determined to proceed without competition based on the exclusive nature of the ThyroSeq v3 technology.

The primary purpose of this Special Notice is to inform the contracting community of the VA's intent to award a sole source contract while providing an opportunity for potential competitors to challenge this decision. Interested parties must submit responses by 10:00 AM EDT on September 18, 2025, via email to Jessica.Bryant5@va.gov, providing clear and convincing evidence that competition would be advantageous to the government. No solicitation package is available, and this notice explicitly states it is not a request for competitive proposals or offers. The determination to proceed without competition remains solely at the government's discretion, and telephone inquiries will not be accepted. Contractors seeking to participate must demonstrate compelling reasons why competitive procurement would benefit the VA's acquisition of this specialized genomic diagnostic service for thyroid cancer detection and classification.