RADx® Tech ITAP for Mycobacterium Tuberculosis Complex Near-patient* and/or Lab-based Diagnostics
General
What is the RADx® Tech Independent Test Assessment Program (ITAP) for Mycobacterium tuberculosis Complex Near-patient* and/or Lab-based Diagnostics?
In collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and the FDA, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Rapid Acceleration of Diagnostics (RADx®) Tech program is soliciting proposals to accelerate the validation, 510(k) submission, and commercialization of near-patient and/or lab-based molecular tests that can detect, at-minimum, Mycobacterium tuberculosis complex. Ideally, the diagnostic test would also include targets for detection of mutations associated with resistance to at least rifampicin with a desire for additional targets covering other drugs/drug classes including isoniazid and fluoroquinolones. Tests that include at-minimum these additional targets, or have reflex tests that include these additional targets, are encouraged.
What technologies will be considered?
Test manufacturers with existing technologies for detection of Mycobacterium tuberculosis complex and targets associated with drug resistance that can quickly enter production and meet the FDA’s performance/quality standards are encouraged to apply. ITAP will help accelerate the validation, 510(k) submission, and commercialization of select diagnostics.
How will these technologies be assessed?
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to:
- Product must be at or near design lock
- Preliminary analytical and clinical performance data indicates high sensitivity and specificity for the detection of Mycobacterium tuberculosis and targets associated with drug resistance with equal or better performance than existing devices, when applicable
- Applicant has an established quality management system (QMS)
- Demonstrated capacity for manufacturing scale-up and distribution
- Robust commercialization strategy
- At-minimum sputum-based diagnostic; tests that also include non-sputum sample types are encouraged
- Reportable results for both M. tuberculosis identification and resistance-associated targets
- Preference of <2 hours test time to result
Can applicants from outside the U.S. apply?
Yes, applicants from all geographies are encouraged to apply. Preferably, test manufacturers will be incorporated in and maintain a primary place of business in the United States.
Can diagnostic test components be manufactured outside the U.S.?
Yes. At this time there are no requirements that test supplies and components be manufactured exclusively within the U.S.
Do plans for marketing have to include the U.S.?
Yes, project teams must plan to market and deploy the test within the U.S.
How will the submission process be administered?
The registration and submission portals are administered by Cimit serving as the RADx Tech Coordination Center and operating under a contract with the NIH.
When can proposals be submitted?
Proposals may be submitted until October 29, 2026, at 11:59 PM ET. The link to the current solicitation can be found here.
Will NIH provide summary feedback as to why a submission was not selected?
No, NIH does not intend to provide innovators with individual reviews or summaries of reviewer feedback in any phases of the program. This is due to the sheer number of anticipated submissions and the urgent need for NIH to focus its efforts on advancing selected proposals. Innovators who were not selected for RADx Tech support are encouraged to consider other NIH funding opportunities.
Where can I get more information?
Information about this project and how to submit a proposal can be found on the Cimit solicitation website.
*Also termed “point-of-care" (POC), near-patient typically refers to patient care settings where testing can be completed near the patient, such as at the bedside in a hospital or at a health clinic, physician office, or pharmacy. Near-patient settings performing clinical testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS).
Deadline
October 29, 2026
11:59PM ET