Q301 - THYRO SEQ V3 GENOMIC CLASSIFIER (GC) TESTING

Notice of Intent to Sole-Source Requirement

The Department of Veterans Affairs, Network Contracting Office (NCO) 10, intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The associated NAICS code for this is 621511, Size Standard is $41.5 Million. The Product Service Code (PSC) is Q301.

The sole-source contract will be awarded to:
CYTOPATH BIOPSY LAB INC 
UEI: KC5VWAGMNLT6

Description of equipment requirements:
The VA Northeast Ohio Healthcare System (VANEOHS), Pathology and Laboratory Medicine Service (PALMS), requires molecular diagnostic testing services using the ThyroSeq v3 Genomic Classifier (GC). The ThyroSeq v3 Genomic Classifier is a proprietary molecular assay exclusively developed, validated, and performed by CBL PATH, which is the sole source provider of this test in the United States.

It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source. This notice of intent is not a request for competitive proposals. IAW FAR 5.207 all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. 

This is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that demonstrates the ability to comply with the requirement and that competition would be advantageous to the Government. 

The Government will not pay for information submitted. A determination not to compete based on responses to this notice is solely within the discretion of the Government.

All responses to this intent to sole source must be emailed to Thomas Bellamy @ thomas.bellamy@va.gov by 3:00 p.m. EST November 12th, 2025.