Notice of Intent to Sole Source – Cepheid
Closed Special Notice Posted
- Solicitation number
- 26-001331
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339112 Surgical and Medical Instrument Manufacturing
- Place of performance
- California 94089, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center's Department of Laboratory Medicine has published a Notice of Intent to Sole Source a purchase order to Cepheid for clinical testing kits. Posted on February 24, 2026, this special notice indicates the NIH's intention to award a firm fixed price sole source contract to Cepheid for the provision of testing kits compatible with the agency's existing laboratory instrumentation. The procurement falls under the simplified acquisition procedures outlined in Federal Acquisition Regulation Part 13, which permits single-source awards when circumstances deem only one source reasonably available. This is a notice of intent rather than a formal request for quotation, and no competitive solicitation will be issued. The clinical testing kits will support the continued operations of the Department of Laboratory Medicine at the NIH Clinical Center in Bethesda, Maryland.
Cepheid is identified as the sole manufacturer and developer of the GeneXpert 4-drawer and 12-drawer instruments currently in use at the NIH Clinical Center, making them the only authorized vendor for compatible testing kits. These instruments provide rapid detection of nucleic acids from clinical samples, enabling timely identification of infectious agents and facilitating expedited patient treatment. The Notice of Intent is posted with a due date of March 3, 2026, allowing interested parties an opportunity to submit comments or protests regarding the sole source justification. No set-aside provisions apply to this procurement, and no specific eligibility criteria exist for participation since this is not a competitive solicitation. Contractors seeking information should reference POTS number 26-001331 and note that this acquisition is exempt from the competition requirements outlined in FAR Part 6 due to its status as a simplified acquisition procedure award.
Notice text
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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