National Institute of Biomedical Imaging and Bioengineering (NIBIB) Innovation

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), posted through the NIH Office of Logistics and Acquisition Operations, seeks capability statements from qualified sources for a Clinical Validation Core supporting the NIH Rapid Acceleration of Diagnostics (RADx) Initiative, with responses due December 4, 2026 at 12:00 PM ET. The notice uses no set-aside, and it does not obligate the government to award a contract or compensate respondents for submitted information.

The core would provide analytical, clinical, technical, and human factors validation services for prototype diagnostic devices. Respondents must demonstrate established processes for developing diagnostic testing protocols, the ability to conduct at least 50 analytical and/or clinical validation studies within a 12-month period, access to BioSafety Level 2 or greater facilities, a network of clinicians across multiple specialties, prospective human clinical sample collection capabilities, and experience managing clinical sample repositories or biobanks. Respondents must also show up-to-date knowledge of FDA regulatory guidance for diagnostics, along with standard protocols, templated validation reports, laboratory equipment, IT data management systems, and legal services for NDAs and MTAs.

Capability statements are limited to five pages, excluding CVs and past performance appendices, and must use at least 12-point font. Each of the 12 capability statement requirements must be addressed separately. Submissions must include company information, GSA Schedule contracts if applicable, CVs of key personnel, and descriptions of facilities and equipment, delivered electronically in MS Word or PDF format to Noelle DeCenzo (noelle.decenzo@nih.gov) and Melanie Suarez (melanie.suarez@nih.gov). The procurement is classified under NAICS 541618 and PSC R410.