RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis C Virus (HCV) RNA Point-of-Care (POC)* Diagnostics FAQs
What is the RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis C Virus (HCV) RNA Point-of-Care (POC) Diagnostics?
In collaboration with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC)* tests for hepatitis C virus (HCV) RNA detection and quantitation.
Test manufacturers with existing technologies for HCV RNA detection and quantitation that can quickly enter production and meet the U.S. Food and Drug Administration's (FDA’s) performance/quality standards are encouraged to apply. ITAP will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA POC diagnostics. While priority will be given to HCV tests, proposals may also include hepatitis B virus (HBV) qualitative DNA POC tests given the importance of knowing the presence of detectable HBV DNA in a patient undergoing treatment for hepatitis C.
What technologies will be considered?
ITAP will consider applications from test manufacturers with existing technologies that can quickly enter production and can meet the FDA’s performance/quality standards for authorization.
Because status of HBV infection is necessary prior to initiating hepatitis C treatment (as well as HIV and pregnancy for which POC tests already exist), in addition to POC tests for HCV RNA Detection and Quantitation, ITAP will also consider applications that include POC tests for the detection of HBV Qualitative DNA.
ITAP will not consider applications for tests for HCV antibodies.
How will these technologies be assessed?
Organizations applying to ITAP will be evaluated based on several criteria, including but not strictly limited to:
Demonstrated capacity for manufacturing and distributing high-quality in-vitro diagnostics, AND at least one of the following:
- An existing technology adapted for POC detection and quantitation of HCV RNA, at design lock, with analytical and clinical performance data available
- May include detection of HBV DNA for diagnosis of individuals undergoing HCV therapy
- An existing HCV RNA test kit, available for POC diagnostic use in international markets
- May include detection of HBV DNA for diagnosis of individuals undergoing HCV therapy
- An existing HBV DNA test kit, available for POC diagnostic use in international markets
Can applicants from outside the U.S. apply?
Yes, applicants from all geographies are encouraged to apply.
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 February 26, 2023, 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 Point of Care Technologies Research Network (POCTRN) website.
*Point-of-care (POC) 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. POC 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).
What is the RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis C Virus (HCV) RNA Point-of-Care (POC) Diagnostics?
In collaboration with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC)* tests for hepatitis C virus (HCV) RNA detection and quantitation.
Test manufacturers with existing technologies for HCV RNA detection and quantitation that can quickly enter production and meet the U.S. Food and Drug Administration's (FDA’s) performance/quality standards are encouraged to apply. ITAP will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA POC diagnostics. While priority will be given to HCV tests, proposals may also include hepatitis B virus (HBV) qualitative DNA POC tests given the importance of knowing the presence of detectable HBV DNA in a patient undergoing treatment for hepatitis C.
What technologies will be considered?
ITAP will consider applications from test manufacturers with existing technologies that can quickly enter production and can meet the FDA’s performance/quality standards for authorization.
Because status of HBV infection is necessary prior to initiating hepatitis C treatment (as well as HIV and pregnancy for which POC tests already exist), in addition to POC tests for HCV RNA Detection and Quantitation, ITAP will also consider applications that include POC tests for the detection of HBV Qualitative DNA.
ITAP will not consider applications for tests for HCV antibodies.
How will these technologies be assessed?
Organizations applying to ITAP will be evaluated based on several criteria, including but not strictly limited to:
Demonstrated capacity for manufacturing and distributing high-quality in-vitro diagnostics, AND at least one of the following:
- An existing technology adapted for POC detection and quantitation of HCV RNA, at design lock, with analytical and clinical performance data available
- May include detection of HBV DNA for diagnosis of individuals undergoing HCV therapy
- An existing HCV RNA test kit, available for POC diagnostic use in international markets
- May include detection of HBV DNA for diagnosis of individuals undergoing HCV therapy
- An existing HBV DNA test kit, available for POC diagnostic use in international markets
Can applicants from outside the U.S. apply?
Yes, applicants from all geographies are encouraged to apply.
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 February 26, 2023, 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 Point of Care Technologies Research Network (POCTRN) website.
*Point-of-care (POC) 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. POC 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).