SAM #NOI-OD-26-008338

NIH Sole Source for Laboratory Genetic Testing Services to PreventionGenetics LLC

The National Institutes of Health (NIH) Clinical Center is announcing its intent to sole source laboratory genetic testing services to PreventionGenetics LLC. - Government Buyer: - Agency: National Institutes of Health (NIH) - Sub-agency: Clinical Center - Office: Office of Purchasing and Contracts - OEM/Vendor: - PreventionGenetics LLC (sole source provider) - Services Requested: - Laboratory genetic testing services - CLIA-certified testing - TNXB gene analysis - CAH-X characterization - Comprehensive EDS (Ehlers-Danlos Syndrome) genetic testing - Continuity with historical patient samples and proprietary testing databases - Unique/Notable Requirements: - Access to proprietary historical testing databases and retained patient samples - Established, proprietary testing methodologies required for ongoing clinical research integrity and continuity - Only PreventionGenetics LLC can meet these technical and continuity requirements - Period of Performance: - One-year base period with four one-year option periods (up to five years total)

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.

This procurement is for a one-year base period and four one-year option periods of laboratory genetic testing services with PREVENTIONGENETICS LLC. Based on the department's review of available testing capabilities and the unique technical requirements of the protocol, no other source has been identified that can provide the combination of CLIA-certified testing, historical sample continuity, TNXB gene analysis, CAH-X characterization, and comprehensive EDS genetic testing required to meet the Government's needs. Consequently, Prevention Genetics is the only responsible source capable of providing the required services without substantial duplication of cost, disruption to ongoing research activities, and unacceptable risk to the integrity of long-term clinical research data. Due to the proprietary nature of the contractor's historical testing database, retained patient samples, and established testing methodology used throughout the study, the Government is unable to overcome the barriers to competition without incurring substantial duplication of cost and compromising the continuity and validity of ongoing research efforts.

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.

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 Ryssa Nix, Contract Specialist via email to Ryssa.nix@nih.gov by close date.

Notice Type: Notice of Intent

NAICS Code: 621511

PSC Code: Q301

Posted Date: 07/30/2026

Close Date: 08/13/2026 12pm EST

End User IC: Clinical Center

POC Name: Ryssa Nix

Email Address: Ryssa.nix@nih.gov

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