Sources_Sought_Notice-_Validation_Center___11022026_1.pdf

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), cross-reactivity, human factors, engineering design, clinical sensitivity and specificity.

4. Demonstrate the ability to conduct at least 50 analytical and/or clinical validation studies during a 12-month period.

5. Demonstrate access to and experience with BioSafety Level 2 (or greater) facilities.

6. Demonstrate access to a network of clinicians across a broad range of specialties related to medical diagnostics.

7. Demonstrate ability to prospectively collect human clinical samples and other relevant measurements.

8. Demonstrate experience with managing and overseeing a clinical sample repository or biobank.

9. Demonstrate up-to-date knowledge of FDA regulatory guidance for the diagnostic industry.

10. CVs detailing the professional qualifications of technical and medical experts, entrepreneurs and business experts, and other personnel as it relates to the above outlined requirements,

11. A description of general and specific facilities and equipment currently available, including computer equipment and software (i.e., detail what equipment/software/internet backbone is on hand to complete this task), and

12. Any other information considered relevant to this program.

13. General Information

a. Please provide your Company Name, Company Address, Company Website, Point of Contact Name, Point of Contact Email, and Point of Contact Phone Number.

b. What are your current GSA Schedule Contracts as applicable to this RFI?

c. What type of Company are you responding for, as shown in SAM?

d. What is your UEI (formally DUNS) number?

Project Requirements for Clinical Validation Core

• Provide standard processes to develop protocols for conducting analytical and clinical validation studies of diagnostic devices.

• Provide templated validation reports that give critical feedback to device developers.

• Provide technical and clinical expertise in diagnostic device evaluation, as well as laboratory capabilities.

• Provide all required laboratory equipment to complete analytical and clinical validation studies.

• Provide BioSafety Level 2 (or greater) facilities.

• Provide sites for collection of human clinical samples, usability and human factors testing, and/or related measurements.

• Provide facilities and resources for storage of human clinical samples.

• Provide IT systems and support for data management and reporting.

• Provide legal services to support non-disclosure agreement (NDA) and material transfer agreement (MTA) policies.

The capability statement must not exceed 5 pages in length, excluding CVs and past performance (include as an Appendix), and using a 12-point font size minimum.

The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non- responsive. When submitting this information, please reference the sources sought notice number.

All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Noelle DeCenzo, Contract Specialist, at noelle.decenzo@nih.gov and Melanie Suarez, Contracting Officer, at melanie.suarez@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by December 4, 2026, at 12PM ET. All responses must be mailto:noelle.decenzo@nih.gov mailto:melanie.suarez@nih.gov received by the specified due date and time in order to be considered.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.

Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's capabilities.