Notice of Intent to Sole Source – LGC Diagnostics
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH) intends to award a fixed-price sole source purchase order to LGC Clinical Diagnostics Inc. for HIV-1 and Hepatitis C Virus (HCV) validation panels. This acquisition is crucial for the analytical and clinical validation of the Roche cobas® 5800 molecular diagnostic system at the NIH Clinical Center in Bethesda, MD. This is a Notice of Intent, not a request for quotation. Interested parties may submit their capabilities to challenge the sole source by March 10, 2026, at 9 AM EST.
Scope of Work
The requirement is for LGC HIV-1 and HCV validation panels. These panels must consist of highly characterized and traceable viral materials that are commutable and appropriate for nucleic acid amplification testing. They need to span clinically relevant viral load concentrations across the analytical measurement range of the Roche assays, allowing for accurate assessment of assay performance characteristics including sensitivity, linearity, and reproducibility. Comprehensive documentation, including certificates of analysis and stability data, is also required to support validation records and regulatory/accreditation review.
Justification for Sole Source
LGC is identified as the only supplier capable of providing panels that meet the specific technical and regulatory requirements for validating the Roche cobas® 5800 system. Alternative commercial products were evaluated and found unsuitable due to lacking the necessary level of characterization, traceability, documentation, or concentration range. Using alternatives would introduce unacceptable risk, potentially delaying validation, impacting laboratory operations, testing availability, and patient care.
Contract & Timeline
- Type: Notice of Intent to Sole Source (Fixed-Price Purchase Order)
- NAICS Code: 339112 – Surgical and Medical Instrument Manufacturing
- Product Service Code: 6515 – Medical Instruments, Equipment, and Supplies
- Place of Performance: Bethesda, MD 20892, USA
- Response Due: March 10, 2026, 9 AM EST
- Published: March 3, 2026
Action for Interested Parties
This acquisition is being conducted under FAR Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1). While a solicitation will not be issued, interested parties may identify their interest and capabilities in response to this posting. The government's determination not to compete this requirement is solely at its discretion.
Contact Information
For comments or inquiries, reference the posting number and contact Kristin Nagashima, Contract Specialist, via email at Kristin.nagashima@nih.gov.