Notice of Intent to Sole Source – Roche Diagnostics Corporation

The National Institutes of Health Clinical Center intends to sole source a one-year automated molecular diagnostic testing platform contract to Roche Diagnostics Corporation, with contract performance from August 18, 2026 through August 17, 2027 and a comment deadline of August 16, 2026 at 12:00 PM EST.

This is a reagent rental arrangement structured as firm-fixed-price and valued at $350,000 for the base year. The procurement is conducted under FAR Part 13 Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), which exempts the acquisition from FAR Part 6 competition requirements. The contracting officer determined that Roche is the only source reasonably available to meet the Government's operational requirements.

Performance occurs at the NIH Clinical Center, where the Roche cobas 5800 platform will consolidate molecular diagnostic testing currently distributed across multiple systems (Hologic Panther Fusion, bioMerieux EMAG, and Thermo Fisher QuantStudio). The system will support clinical testing for Cytomegalovirus, Epstein-Barr Virus, BK Virus, respiratory viruses including SARS-CoV-2, Influenza A and B, and Respiratory Syncytial Virus, with future expansion to Adenovirus testing. The contract includes instrumentation, reagents, controls, calibrators, consumables, technical and maintenance support, operator training, and warranty coverage.

The justification for sole source cites workflow consolidation, reduction of manual processing, FDA-cleared methodology transition, continuity of operations through instrument redundancy with existing Roche cobas systems, laboratory space compatibility, and future testing expansion needs. No formal solicitation will be issued. Comments should be directed to Ryssa Nix, Contract Specialist, at ryssa.nix@nih.gov.