Independent Test Assessment Program (ITAP) for Multiplex POC and OTC Diagnostics for COVID-19 and Flu
Overview
In partnership with 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 innovative point-of-care (POC) and over-the-counter (OTC) multiplex tests that can detect at-minimum COVID-19, Flu A and Flu B. Tests that include additional respiratory targets (e.g., H5N1, RSV) 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 combination COVID-19, Flu A, and Flu B virus POC and OTC tests. NIBIB plans to provide support required to accelerate test validation and regulatory review of molecular and antigen-based POC and OTC tests.
Applicants are expected to self-fund all 510(k) analytical and clinical studies.
NIBIB will not consider applications for tests of past infection or immunity (e.g., antibody tests).
Evaluation Criteria
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to:
- Product must be design locked
- Preliminary analytical and clinical performance data indicates a high likelihood to meet
- FDA 510(k) acceptance criteria
- Applicant has an established quality management system (QMS)
- Demonstrated capacity for high volume manufacturing scale-up and distribution
- Robust commercialization strategy
- Reportable results (e.g., compliance and implementation of MARS standards)
Other factors considered for selection:
- <30 minutes time to result
- <$10 COGS per test or product suited for broad implementation in low-resource settings
- Improved usability / accessibility (e.g. reduced number of steps & components,
- minimal/no fluid transfer, use of recognizable tactile features, multi-modal results output,
- etc.)
- Path to ≥2-year shelf life
- Novel targets (e.g., H5N1)
- Compatibility with multiple sample types
- Shipping does not require controlled temperature
Begin your application here. Applications are due no later than April 17, 2025 by 11:59PM ET.
Questions? Please visit the FAQs page or send inquiries to itapnibib@mail.nih.gov.
Overview
In partnership with 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 innovative point-of-care (POC) and over-the-counter (OTC) multiplex tests that can detect at-minimum COVID-19, Flu A and Flu B. Tests that include additional respiratory targets (e.g., H5N1, RSV) 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 combination COVID-19, Flu A, and Flu B virus POC and OTC tests. NIBIB plans to provide support required to accelerate test validation and regulatory review of molecular and antigen-based POC and OTC tests.
Applicants are expected to self-fund all 510(k) analytical and clinical studies.
NIBIB will not consider applications for tests of past infection or immunity (e.g., antibody tests).
Evaluation Criteria
Organizations applying to ITAP will be evaluated for participation based on several criteria, including but not strictly limited to:
- Product must be design locked
- Preliminary analytical and clinical performance data indicates a high likelihood to meet
- FDA 510(k) acceptance criteria
- Applicant has an established quality management system (QMS)
- Demonstrated capacity for high volume manufacturing scale-up and distribution
- Robust commercialization strategy
- Reportable results (e.g., compliance and implementation of MARS standards)
Other factors considered for selection:
- <30 minutes time to result
- <$10 COGS per test or product suited for broad implementation in low-resource settings
- Improved usability / accessibility (e.g. reduced number of steps & components,
- minimal/no fluid transfer, use of recognizable tactile features, multi-modal results output,
- etc.)
- Path to ≥2-year shelf life
- Novel targets (e.g., H5N1)
- Compatibility with multiple sample types
- Shipping does not require controlled temperature
Begin your application here. Applications are due no later than April 17, 2025 by 11:59PM ET.
Questions? Please visit the FAQs page or send inquiries to itapnibib@mail.nih.gov.