NOI to Sole Source to One Lambda, Inc.
Closed Pre-Solicitation Posted
- Solicitation number
- NOI-OD-26-000027
- Agency
-
Office of Logisitics and Acquisition Operations
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
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health intends to award a one-year sole source contract to One Lambda, Inc. for HLA typing and antibody screening reagents, with performance scheduled from June 2026 to May 2027. This acquisition is being conducted under FAR Part 13 Simplified Acquisition Procedures and does not require competitive solicitation; the NOI represents the formal notice of intent rather than a request for quotation.
One Lambda is the sole justified source because it is the only manufacturer of the specific LABType, LABScreen, and Secore HLA typing and antibody screening kits currently validated and in use by the NIH HLA Lab. The NIH Clinical Center has completed extensive validation testing on these reagents, documenting their accuracy, precision, and superior ability to resolve testing ambiguities compared to alternatives evaluated. Switching vendors would require approximately two months of re-validation testing, significantly disrupting the lab's ability to provide timely patient results for transplant protocols.
Place of performance is the NIH Clinical Center in Bethesda, Maryland. One Lambda will deliver reagents on an as-needed basis within one week of request unless otherwise specified during ordering, under a firm fixed price arrangement. The reagents support clinical diagnostic testing for transplant patients and protocol enrollment determination. NAICS 339112 (Surgical and Medical Instrument Manufacturing); PSC 6640 (Laboratory Equipment and Supplies).
Notice text
The purpose of this acquisition is to provide HLA typing and antibody screening reagents to the HLA Lab on a regular basis. One Lambda (vendor) will ship reagents included on the quote on an “as needed/requested” basis. Vendor will provide the reagents within 1 week, unless otherwise specified during ordering.
• Product Service Code: 6640 – Laboratory Equipment and Supplies
• NAICS Code: 339112 – Surgical and Medical Instrument Manufacturing
• Place of Performance: NIH Clinical Center, Bethesda, MD 20892 USA
POTS: 26-000027
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 one-year contract to One Lambda Inc., located at 22801 Roscoe Blvd, West Hills, CA 91304, on a firm fixed price sole source award basis for the purchase of Reagents for HLA Typing and Antibody Screening of NIH Transplant Protocols.
The proposed vendor, One Lambda Inc., is the only manufacturer of these specific HLA typing and antibody screening reagents. The HLA Lab currently uses these reagents to test our patients. The reagents provided by One Lambda have been previously tested in the lab and provide a greater ability to resolve testing ambiguities than other vendors tested. All validation testing has been completed for these reagents so there is laboratory documentation available to confirm the accuracy and precision of these reagents. A change in vendors/reagents would require extensive validation and would take approximately 2 months. This would greatly impact the ability of the HLA Lab to provide timely results.
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.
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 Huda Malik, Contract Specialist via email to huda.malik@nih.gov by May 27, 2026 by 10 am EST.
Files
| File | Type | Posted |
|---|---|---|
| JOFOC_FY26 One Lambda - Copy.docx | DOCX document |
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