Sources Sought Notice- Validation Center 1

National Institute of Biomedical Imaging and Bioengineering (NIBIB) Innovation Funnel Clinical Validation Core Sources Sought Notice

This is a Sources Sought notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.
Background
In response to the 2019 pandemic, the NIH Rapid Acceleration of Diagnostics (RADx) Initiative was created to speed innovation in the development, commercialization, and implementation of technologies. Operating with an innovation funnel model, RADx was designed to compress the customary technology development timeline, helping technologies reach the marketplace 2-5x faster. This was accomplished by employing, in parallel, expert teams to address technical, regulatory, clinical, and commercialization requirements. Leveraging this infrastructure, it is envisioned that innovations in diagnostic technologies will enable preparedness for future pandemics, as well as provide advances to the current healthcare paradigm.
The program hopes to continue efforts to support the acceleration of novel, diagnostic and monitoring technologies for use across a broad range of clinical indications and use settings. To support rapid technology development, technical, analytical, human factors, and clinical validation services are required to assess the performance of prototype diagnostic devices and to recommend optimizations and improvements. Independent third-party validation of performance criteria is key benchmark in determining technological feasibility, as well as the foundational support for regulatory filings. Capability Statement Requirements for the Clinical Validation Core Sources that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. Capability Statements will be evaluated based on the following requirements:
1. The capabilities statement must specifically address each project requirement separately. 2. Documented experience with similar large-scale project requirements in which the organization and proposed personnel have participated (provide list of projects for the past three years). 3. Demonstrate an established process to collaborate with the inventor(s) and regulatory experts to develop and implement diagnostic testing protocols, including limit of detection (LOD), crossreactivity, human factors, engineering design, clinical sensitivity and specificity.