The Karius Test® Molecular Diagnostic Testing
Closed Pre-Solicitation Posted
- Solicitation number
- NIH-CC-OPC-25-008008
- 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
- 621511 Medical Laboratories
- PSC
- Q301 Reference Laboratory Testing
- Place of performance
- Bethesda, Maryland 20892, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Health Clinical Center intends to award a sole-source firm fixed-price contract to Karius, Inc. of Redwood City, California for specialized molecular diagnostic testing services known as The Karius Test. This testing involves liquid biopsy procedures to detect over 1,000 pathogens non-invasively and rapidly, supporting clinical management and patient monitoring at the NIH Clinical Center's Department of Laboratory Medicine. The agency has determined that Karius, Inc. is the only vendor capable of providing this specialized testing from their CLIA-certified laboratory facility. However, the agency is soliciting capability statements from other potential vendors to determine whether competitive procurement should be pursued instead of the planned sole-source award. Interested companies must submit capability statements including their SAM UEI, company information, GSA schedules or appropriate NAICS codes, and detailed capability information to Kimala Winfield or Malinda Dehner by the June 30, 2025 deadline. The procurement falls under FAR Part 13 Simplified Acquisition Procedures and is classified under NAICS code 621511 for Medical Laboratories.
This procurement does not utilize any set-aside designations and is open to all qualifying vendors who can demonstrate equivalent capabilities to the incumbent Karius, Inc. The contract structure includes a base period of twelve months from the date of award, followed by three additional one-year option periods, potentially extending the total contract duration to four years. The acquisition is being conducted under the simplified acquisition threshold, allowing for streamlined procurement procedures and exemption from standard competition requirements under FAR Part 6. This is specifically a Notice of Intent rather than a formal solicitation, meaning no quotations are being requested at this time and the final decision to proceed with sole-source or competitive procurement remains at the government's discretion. The contract will support the Microbiology Service's continued need for uninterrupted pathogen detection capabilities to guide patient care decisions at the Clinical Center.
Notice text
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 Institute of Health/Clinical Center/Office of Purchasing and Contracts intends to award a firm fixed-price contract to KARIUS, INC. Redwood City, California 94065 to procure The Karius Test® for Molecular Diagnostic Testing in the Department of Laboratory Medicine (DLM) at the NIH Clinical Center.
KARIUS, INC. is the only vendor that can provide the specialized testing. The testing will be performed by liquid biopsy to detect various pathogens and is only available from this CLIA-certified laboratory. Karius, Inc. is a laboratory that performs specialized molecular diagnostic testing to detect over 1,000 pathogens non-invasively and rapidly screen patients from liquid biopsy specimens. The continued utilization of this vendor by the Microbiology Service will ensure the uninterrupted acquisition of data, which aids in guiding clinical management and monitoring of patient progress at the Clinical Center. Period of Performance shall be for a base year of twelve (12) months from the date of award with three (3) one year option periods.
The North American Industry Classification System (NAICS) for this procurement 621511.
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.
This notice of intent to award is not a request for competitive quotations. Interested concerns capable of providing the same products or services as described in this notice may submit a capability statement outlining their capabilities. No solicitation is available. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.
Each response should include the following Business Information:
a. SAM UEI.
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Capability Statement
Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Kimala Winfield, kimala.winfield@nih.gov or Malinda Dehner, dehnerm@cc.nih.gov by the due date and time marked in this notice.
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