The Rapid Acceleration of Diagnostics (RADx®) Independent Test Assessment Program (ITAP) solicitation for near-patient and lab-based MTB diagnostics went live on 9/29/2026.
In collaboration with the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB) 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.
NIBIB is mobilizing and expanding the focus of the RADx Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable tests for M. tuberculosis complex and drug resistance. NIBIB plans to provide support required to accelerate test validation and regulatory review. NIBIB will consider applications from test manufacturers who are incorporated in and maintain a place of business in the United States and have existing products that can quickly scale production and demonstrates high performance.
The NIBIB RADx Tech Program is a fast-track national initiative launched by the National Institutes of Health (NIH) on April 29, 2020, to rapidly develop, validate, and commercialize innovative diagnostic testing technologies. It is managed by the NIBIB in conjunction with the Point-of-Care Technology Research Network (POCTRN) and CIMIT. For more information, see the CIMIT announcement here.
