Q301 - Thyro Seq v3 Genomic Classifier (GC) Testing

Closed Special Notice Posted

This opportunity was awarded. See the award notice from .

Solicitation number
36C25026Q0100
Agency
Veterans Integrated Service Network 10 Veterans Health Administration, Department of Veterans Affairs
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
621511 Medical Laboratories
PSC
Q301 Reference Laboratory Testing
Place of performance
Ohio 44106, United States
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs, Veterans Integrated Service Network 10, has published a Notice of Intent to Sole-Source a contract for molecular diagnostic testing services. The VA Northeast Ohio Healthcare System's Pathology and Laboratory Medicine Service requires ThyroSeq v3 Genomic Classifier testing, a proprietary assay exclusively developed and performed by CYTOPATH BIOPSY LAB INC. The contracting action is being executed under Simplified Acquisition Procedures pursuant to FAR 6.302-1, citing that only one responsible source can satisfy the agency's requirements. The Product Service Code is Q301 (Reference Laboratory Testing), and the NAICS category is 621511 (Medical Laboratories) with a size standard of $41.5 million. This notice was posted on November 4, 2025, and represents the VA's intention to negotiate directly with the identified sole-source provider.

Despite the stated intent to sole-source, the VA is accepting capability statements, proposals, or quotations from all responsible sources through November 12, 2025, at 3:00 p.m. EST, in accordance with FAR 5.207. Any interested contractors must submit clear and convincing evidence demonstrating their ability to comply with the requirement and proving that competition would be advantageous to the Government. Responses should be emailed to Thomas Bellamy at thomas.bellamy@va.gov, and the Government reserves the right not to compete based on submitted responses. There is no formal solicitation package available, and no compensation will be provided for information submitted. The Government will make a final determination regarding competition at its sole discretion.

Notice text

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.
 

Notice history

Notices posted for this opportunity, newest first
Notice Type Posted
Q301 - Thyro Seq v3 Genomic Classifier (GC) Testing Award Award Notice
Q301 - Thyro Seq v3 Genomic Classifier (GC) Testing This notice · Latest special notice Special Notice

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