SAM #26-010014

Sole Source Laboratory Testing Services – clonoSEQ Assay by Adaptive Biotechnologies for NIH Clinical Center

This notice announces the NIH Clinical Center's intent to award a sole source contract for specialized laboratory testing services. - Agency: National Institutes of Health (NIH) Clinical Center, Department of Health and Human Services - Service: clonoSEQ Assay Laboratory Testing for Minimal Residual Disease (MRD) - Used for immunocompromised patients and those with advanced hematologic malignancies - Vendor: Adaptive Biotechnologies Corporation - Identified as the only source capable of providing the proprietary clonoSEQ Assay - Procurement Type: Sole source, firm fixed price award - Conducted under FAR Part 13 Simplified Acquisition Procedures - No solicitation or quotations requested - Place of Performance: Bethesda, MD - NAICS Code: 339112 (Surgical and Medical Instrument Manufacturing) - Product Service Code: 6515 (Medical Instruments, Equipment, and Supplies) - NIH Department of Laboratory Medicine lacks in-house capability, equipment, and reagents for this testing - Commercial opportunity is limited due to sole source justification

Key Details: - Only Adaptive Biotechnologies can provide the required MRD testing services - No competing vendors or products identified - Service is critical for patient care in advanced hematologic malignancies

Description

The primary purpose of this non-competitive acquisition is to secure a new, specialized reference laboratory testing services agreement with Adaptive Biotechnologies Corporation for the proprietary clonoSEQ® Assay. The National Institutes of Health (NIH) Clinical Center (NIH CC) maintains a large, highly vulnerable patient population consisting of individuals who are immunocompromised or diagnosed with advanced hematologic malignancies. Currently, the Department of Laboratory Medicine (DLM) does not possess the in-house capabilities, equipment, or reagents required to offer Minimal Residual Disease (MRD) testing.

•             Product Service Code: 6515 – Medical Instruments, Equipment, and Supplies

•             NAICS Code: 339112 – Surgical and Medical Instrument Manufacturing

•             Place of Performance: Bethesda, MD 20892 USA

POTS: 26-010014

Description:

This is a notice of intent, not a request for a quotation.  A solicitation document will not be issued and quotations will not be requested.

The National Institutes of Health (NIH) intends to award a fixed price purchase order to Adaptive Biotechnologies Corporation, located at 1165 Eastlake Ave E, Seattle, WA, on a firm fixed price sole source award basis to provide laboratory testing services to the National Institutes of Health.

The proposed vendor, Adaptive Biotechnologies Corporation, is the only source available to review and provide accreditation to healthcare organizations nationwide.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Kristin Nagashima, Contract Specialist via email to Kristin.nagashima@nih.gov by September 25, 2026 at 9am EST.

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