RADx® Tech Independent Test Assessment Program for Mycobacterium Tuberculosis Complex Near-patient* and/or Lab-based Diagnostics

Overview

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.

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. 

Evaluation Criteria

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

*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).