Notice of Intent to Sole Source – Cepheid

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Contract Opportunity

This procurement is for testing kits from vendor Cepheid for the continued provision of clinical testing at the National Institutes of Health (NIH) Clinical Center (CC) Department of Laboratory Medicine (DLM) with existing instrumentation and established assays.

• 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: 26-001331

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 Cepheid, located at 904 East Caribbean Drive, Sunnyvale, CA, 94089, on a firm fixed price sole source award basis to provide testing kits to the National Institutes of Health.

The proposed vendor Cepheid is the sole manufacturer, vendor and service provider for existing instrumentation in the DLM (i.e., GeneXpert 4-drawer and 12-drawer). These instruments provide rapid,

efficient, and sensitive detection of nucleic acid (DNA) from clinical samples, which allows for timely identification of the presence of infectious agents and hastens treatment. As sole developer and

manufacturer of these instruments, Cepheid is the only vendor from which purchase of testing kits associated with this existing instrumentation can be made.

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 March 3, 2026 at 11am EST.

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