SAM #36C24426Q0855

Sole Source clonoSEQ MRD Testing Services for Pittsburgh VA Medical Center

This opportunity is a sole source procurement for specialized laboratory testing services at the Pittsburgh VA Medical Center. - Agency: Department of Veterans Affairs, Network Contracting Office 4 (NCO 4) - Sole source contract to Adaptive Biotechnologies Corporation - Adaptive Biotechnologies is the OEM and sole provider of the clonoSEQ assay - Requirement: clonoSEQ Measurable Residual Disease (MRD) Testing - FDA-cleared, proprietary molecular test for MRD detection in blood cancers - Annual quantity: 100 tests - Contract duration: five years, firm-priced - No competing vendors or products considered - NAICS code: 621511 (Medical Laboratories) - Commercial opportunity for highly specialized lab testing services - Adaptive Biotechnologies holds exclusive rights to the clonoSEQ assay - No product line items; service line item is clonoSEQ MRD Testing - Estimated contract value: $250,000 - $500,000 (based on typical per-test pricing)

Period of Performance: - Five-year firm-priced contract - Annual provision of 100 tests - Start date: after award; end date: five years from start

Description

NOTICE OF INTENT TO AWARD SOLE SOURCE: The Department of Veterans Affairs (VA) Regional Procurement Office East (RPOE), Network Contracting Office 4 (NCO 4) intends to award a sole source contract pursuant to RFO FAR 6.103-1 to Adaptive Biotechnologies Corporation located at 1165 Eastlake AVE E, Seattle, Washington 98109. Simplified acquisition procedures will be used, and the resulting contract will be firm priced for a five-year period.

The Pittsburgh VA Medical Center requires a contractor to provide clonoSEQ Measurable Residual Disease (MRD) Testing. This service shall be provided for the Department of Veterans Affairs, Pittsburgh VA Medical Center, located at University Drive, Pittsburgh, PA 15240. The clonoSEQ assay is provided exclusively by Adaptive Biotechnologies and is a proprietary, FDA-cleared, patented molecular test developed and performed exclusively by Adaptive Biotechnologies for MRD detection in bone marrow from patients with multiple myeloma and B-cell acute lymphoblastic leukemia (B-ALL), and in blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). It is also a CLIA-validated laboratory developed (LDT) test for diffuse large B-cell lymphoma (DLBCL) and other lymphoid malignancies. 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 the VA facility s needs.

Line Item Description Annual Quantity 1 ClonoSEQ MRD Testing 100

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES; however, any responsible firm that believes it can meet the requirement shall give written notification and capability statements prior to the response due date and time. Vendors shall indicate if they are the direct supplier or service provider of the items and/or authorized reseller/distributor. Supporting evidence shall be furnished in sufficient detail to demonstrate the ability to perform the requirement and shall include relevant experience along with the applicable contract number(s), total contract dollar amount, contract period of performance, details of the relevant supply and/or services, and customer point of contact with corresponding telephone number and email address.

Responses shall include following information: 1. Company Name 2. SAM UEI Number 3. Company s Address 4. Point of Contact Information (title, phone number and email address) 5. Business Size

Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based on responses to this notice is solely within the discretion of the Government. Information provided will not be returned. Responses are due by Monday, 8/10/2026 at 8:00 AM Eastern Standard Time. No submissions will be accepted after this date and time. Responses shall be submitted via email to Mrs. Mickeya Linzie at mickeya.linzie@va.gov.

The NAICS code for this acquisition is 621511 (Medical Laboratories) and the size standard is $41.5 million. Additional Links:Wilmington VA Health Care

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