Notice of Intent to Sole Source – LGC Diagnostics 26-002116

This acquisition is for LGC HIV-1 and Hepatitis C Virus (HCV) validation panels for use in the analytical and clinical validation of the Roche cobas 5800 molecular diagnostic system. These panels are required to complete assay validation in accordance with regulatory, accreditation, and manufacturer requirements prior to implementation of patient testing at the National Institutes of Health (NIH) Clinical Center (CC). Product Service Code: 6515 Medical Instruments, Equipment, and Supplies NAICS Code: 339112 Surgical and Medical Instrument Manufacturing Place of Performance: Bethesda, MD 20892 USA POTS: 26-002116 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 fixed price purchase order to LGC Clinical Diagnostics Inc., on a firm fixed price sole source award basis to provide LGC HIV-1 and Hepatitis C Virus (HCV) validation panels to the National Institutes of Health. LGC is the only supplier able to provide HIV-1 and HCV panels that meet the technical and regulatory requirements necessary for validation of the Roche cobas 5800 system. The LGC panels consist of highly characterized and traceable viral materials that are commutable and appropriate for nucleic acid amplification testing. They 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. In addition, LGC provides comprehensive documentation, including certificates of analysis and stability data, which is required to support validation records and regulatory or accreditation review. Alternative commercial products were evaluated and determined to be unsuitable because they lack the level of characterization, traceability, documentation, or concentration range required for full assay validation. Some alternative materials are intended for routine quality control rather than validation, while others do not have demonstrated compatibility with the Roche cobras 5800 platform. Use of these alternatives would introduce unacceptable risk to the validation process and could necessitate repeat studies or result in noncompliance with regulatory standards. Failure to procure the LGC HIV-1 and HCV panels would delay validation and implementation of the Roche cobras 5800 system, negatively impacting laboratory operations, testing availability, and patient care. Based on these considerations, LGC is the only responsible source capable of providing HIV-1 and HCV validation panels that meet all technical, regulatory, and clinical requirements 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. Interested parties may identify their interest and capabilities in response to this posting. 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 Kristin Nagashima, Contract Specialist via email to Kristin.nagashima@nih.gov by March 10, 2026 at 9am EST.