Q301 - ClonoSEQ Measurable Residual Disease (MRD) Testing Services
Closed Special Notice Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- 36C25026Q0104
- 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
- Cleveland, 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 Special Notice for sole-source procurement of ClonoSEQ Measurable Residual Disease (MRD) testing services. The notice, posted on November 4, 2025, indicates the VA's intention to negotiate directly with Adaptive Biotechnologies Corporation for molecular MRD testing services at the VA Northeast Ohio Healthcare System's Pathology and Laboratory Medicine Service. The procurement falls under NAICS code 621511 (Medical Laboratories) with a size standard of $41.5 million and will be conducted using Simplified Acquisition Procedures under the sole-source authority of FAR 6.302-1. The VA has determined that only Adaptive Biotechnologies possesses the required capabilities to meet this requirement, as it is the exclusive provider of the proprietary clonoSEQ Assay technology in the United States. This notice is not a competitive solicitation and no formal solicitation package is available.
While this is a notice of intent to sole-source, interested parties have until November 12, 2025, to submit capability statements, proposals, or quotations demonstrating clear and convincing evidence of their ability to comply with the requirement and showing how competition would be advantageous to the government. Respondents must email their submissions to the contracting officer; however, the government will not compensate parties for information provided. The decision not to compete based on submissions is entirely discretionary with the government. This opportunity is unrestricted and available to any responsible source, though the VA's stated position is that only Adaptive Biotechnologies can satisfy the specialized molecular MRD testing requirements using the clonoSEQ Assay technology. Any contractor challenging this sole-source determination must provide substantial evidence that alternative sources or services could meet the government's needs.
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:
ADAPTIVE BIOTECHNOLOGIES CORPORATION
UEI: DMW5BNQ331K9
Description of requirements:
The VA Northeast Ohio Healthcare System (VANEOHS), Pathology and Laboratory Medicine Service (PALMS), requires molecular minimal residual disease (MRD) testing services utilizing the clonoSEQ Assay provided exclusively by Adaptive Biotechnologies. The clonoSEQ Assay is a proprietary, patented molecular test developed and performed exclusively by Adaptive Biotechnologies. Adaptive Biotechnologies is the sole source provider of clonoSEQ MRD testing within 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
| Notice | Type | Posted |
|---|---|---|
| Q301 - ClonoSEQ Measurable Residual Disease (MRD) Testing Services | Award Notice | |
| This notice | Special Notice |
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