RADx® Tech Program Frequently Asked Questions

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Purpose of RADx® Tech II Program

What is RADx Tech II?

The Rapid Acceleration of Diagnostics Tech (RADx Tech) fast track program was established to support the development and commercialization of innovative technologies to significantly increase the U.S. testing capacity for SARS-CoV-2, the virus that causes COVID-19. The RADx Tech II program augments RADx Tech to further advance SARS-CoV-2 testing technologies in order to fill specific unmet national needs. 

What are the unmet needs?

There is an ongoing need for: innovative, cost-effective, and accessible home and point-of-care (POC) technologies for screening, surveillance, diagnosis, and prognosis; and for innovative methods and technologies that significantly advance SARS-CoV-2 variant testing capabilities given the ongoing spread of variants.

Description of Tests

Are these antibody tests?

No, these diagnostics will be developed to test for the presence of the SARS-CoV-2 virus or signatures of SARS-CoV-2 infection. Antibody tests are not within the scope of this solicitation. 

How will new tests be different than what is currently available?

RADx Tech II will support the development of new innovative technologies that have important capabilities that are not fully addressed by current technologies. 

Will these tests be cleared by the FDA?

Yes, new tests development through RADx Tech that require regulatory approval will be validated, proved clinically effective, and will need to obtain Emergency Use Authorization (EUA) and/or clearance through the FDA.

What are rapid diagnostic tests?

Rapid diagnostic tests (RDTs) are medical diagnostic tests that provide quick results and can be used in various settings. Results are typically indicated in an hour or less. Pregnancy testing is one example of an RDT, producing results within several minutes. RDTs have become a widely used method to detect a range of infections using blood, saliva, or urine samples. Examples of infections for which RDTs have been developed include malaria, strep throat, STDs, and HIV. Reliable and accurate COVID-19 RDTs are a goal of NIBIB’s Rapid Acceleration of Diagnostics Tech (RADx Tech) initiative.

Will POC technologies for detecting the presence and levels of the host's antibodies be considered? What if a project both directly measures the SARS-CoV-2 virus and also provides antibody results?

The RADx Tech solicitation is focused on developing tests that can accurately detect the presence of SARS-CoV-2, the virus that causes COVID-19, or signatures of SARS-CoV-2 infection in an individual. A combination test that detects virus or signatures of SARS-CoV-2 infection and also includes antibody testing for evidence of a previous SARS-CoV-2 infection will be considered if it meets the stated project criteria. Antibody testing alone will not be accepted as part of RADx Tech II.

Will RADx Tech II support antigen tests that detect the presence of SARS-CoV-2 virus?

Yes. If the proposed test can accurately detect the presence of SARS-CoV-2 in the intended use case setting then it will be considered by RADx Tech II.

Development Process

How will new tests be developed?

Projects will follow a staged approach for development. Ideas will be rapidly reviewed and assessed for support (within one to two weeks). Projects that are funded will also receive in-kind resources to maximally accelerate progress.  NIH will closely monitor progress of each funded project. 

What is POCTRN?

The RADx program leverages the resources and structure of POCTRN, the Point of Care Technology Research Network. POCTRN was established 13 years ago at the NIBIB, a part of the National Institutes of Health (NIH). POCTRN brings together researchers, clinicians, engineers, industry experts and entrepreneurs to create a network that accelerates technology development and drives commercialization and the creation of marketable products.

POCTRN is currently composed of five centers spread throughout the US: Emory University/Georgia Institute of Technology, Johns Hopkins University, Northwestern University, the University of Massachusetts Medical School, and the Consortia for Improving Medicine with Innovation Technology (CIMIT) at Harvard Medical School/Massachusetts General Hospital.

I have heard that this is a “shark tank” approach. Can you explain how that works?

Based on review of the applications, the projects with the most potential for success will be communicated to POCTRN leadership and selected projects will move to a "shark tank" like process for further review and the opportunity to move to a stage of scale-up and manufacturing. The “shark tank” process (known as a Deep Dive)  entails working with a team of healthcare commercialization and subject matter experts over a period of one to two weeks to do a “deep dive” into the details of the project.

How are confidentiality and intellectual property handled?

The information contained within proposals is treated as confidential and all proposal reviewers sign a non-disclosure agreement when accessing the proposals. NIH retains the right to publicly share proposal summaries or abstracts; however, proprietary information will not be shared without the express written consent of the proposal submitter.

Proposals awarded under this solicitation are required to comply with all of the NIH Standard Award Terms and Conditions. Specifically, information on the management of intellectual property can be found in Section 8.2.4 of the NIH Grants Policy Statement. In brief, the Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212; Executive Order 12591; 37 C.F.R. 401 et al; updated April 14, 2018.) is applicable to RADx Tech funding recipients and provides incentives to promote the utilization of inventions conceived or reduced to practice in the performance of federally supported research and development. The Bayh-Dole Act also requires that the government be provided a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world. The Bayh-Dole Act applies to all NIH research and development funding granted to for-profit organizations regardless of size and all non-profit entities.

Technical Assistance

Does the applying project team need to do all the work to get tests to the market?

RADx Tech has assembled a national network of expert technical, clinical, manufacturing, and regulatory advisors who will provide individualized assistance to project teams. NIBIB will provide financial and in-kind support to accelerate scale-up and manufacturing. Project teams will be matched with technical, business, and manufacturing experts to increase the odds of success. To ensure that innovations are available to the public as quickly as possible, NIH will leverage established partnerships with federal agencies, such as ASPR/BARDA, FDA, CDC, and CMS, as well as commercial and private entities to propel technologies developed by RADx Tech into widespread use.

What levels of analytical performance are required for technologies developed under this program?

The levels of analytical performance required will vary depending on the context of use; therefore, NIH is not prescribing specific values. NIH expects that all tests receiving support will deliver a level of performance that is equal to or better than similar technologies that are currently on the market.

Is obtaining FDA clearance necessary before the test can be deployed?

Requirements for FDA clearance and approvals will figure prominently in defining project milestones that must be met for funding continuation and will be a key focus of the work conducted. Some products, such as those intended only for surveillance, do not require FDA clearance. For those products requiring clearance, it is anticipated that tests supported by RADx Tech II will seek Emergency Use Authorization (EUA) from the FDA to permit initial deployment. Projects are expected to continue pursuing the necessary clinical testing and fulfilling any other regulatory requirements for obtaining FDA approval.

Can applicants from outside the U.S. apply?

Yes. NIH encourages all innovators to submit their promising ideas on how to rapidly accelerate diagnostic testing.

Can diagnostic test components be manufactured outside the U.S.?

At this time there are no requirements that supplies and test components be manufactured exclusively within the U.S., however supply sources must be in compliance with current laws and policies. 

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.

We have done test validation in-house. Would you accept our test validation data or require further validation?

RADx Tech reviewers will review all information submitted in response to the solicitation and provide NIH with recommendations as to whether the proposed test may require independent validation.

Will NIH or POCTRN provide summary feedback as to why a proposal was not selected for funding?

Unfortunately no, NIH and POCTRN are not providing summary feedback to proposals that were not selected for the program. This is due to the sheer number that were submitted to the RADx Tech solicitation and the urgent need for NIH to focus its efforts on advancing selected proposals. Applicants who were not selected for RADx Tech support are encouraged to consider other NIH and NIBIB funding opportunities.

What is the feasibility sample size for product performance that would meet the solicitation requirements?

Testnig should be done with a minimum of 30 contrived, frozen, or fresh samples.

General Questions

How much will the new point-of-care tests cost?

Test costs should be competitive with similar products currently on the market. Applications must address materials and manufacturing costs, along with commercialization plans.

What is the source of funding for the RADx Tech II solicitation?

RADx Tech II is supported by the FY21 Coronavirus Response and Relief Supplemental Appropriations Act (PL 116-260).

Where can I get more information?

Information about this project and how to submit a proposal can be found on the POCTRN website.