Luminex LX200 IVD System

The National Institutes of Health, through the Department of Health and Human Services, is seeking to award a firm-fixed-price purchase order for the Luminex LX200 IVD System under a sole source acquisition justified under FAR 6.302-1, as Luminex Corp is the only source capable of providing the system due to its proprietary xMAP multiplexing technology and compliance with 21 CFR Part 11 for electronic records and signatures. The system is required for the Clinical Trials Correlative Laboratory Core at the National Cancer Institute in Bethesda, Maryland, where it will perform high-throughput, multiplexed analysis of up to 100 biomarkers in small-volume clinical samples, supporting critical research with stringent data integrity standards. The solicitation, numbered 75N98026Q00289, was posted on April 29, 2026, with responses due by May 9, 2026, and no competitive evaluation or trade-off methodology is involved due to the exclusive nature of the technology. All performance, inspection, and acceptance activities are expected to occur at the designated place of performance in Bethesda, Maryland, and the system must meet regulatory requirements for in vitro diagnostic devices without alternative compliant offerings available. No contract clauses, packaging specifications, inspection criteria, or detailed evaluation factors are detailed in the notice, as the procurement operates under a non-competitive framework. The only point of contact for submissions is David Shen at david.shen@nih.gov, and no formal representations, certifications, or socioeconomic disclosures from the contractor are provided. Payment and invoicing procedures, accounting lines, contractor security or compliance credentials, and delivery terms such as FOB are not specified, and while the solicitation mentions a Notice of Intent as the sole attachment, no additional documentation or contractual conditions beyond the justification for sole sourcing and regulatory compliance are included. The agency will issue the purchase order shortly after the response deadline, and the procurement is not subject to any set-aside provisions or small business reservations, though small businesses are invited to submit general capability statements for informational purposes.