Jump to questions about...
Purpose of RADx Tech
The Rapid Acceleration of Diagnostics Tech (RADx Tech) fast track program supports 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.
More tests are needed to provide the public with information that will help them make decisions about returning to normal activities and to help reduce the risk of future outbreaks. RADx Tech will support innovative approaches that introduce new test platforms as well as strategies for solving problems that limit current tests.
Description of Tests
No, these diagnostics will be developed to test for the presence of the SARS-CoV-2 virus. Antibody tests reveal if you have antibodies to the virus, indicating you may have been infected in the past.
RADx Tech will support the development of new tests with improved technical performance and convenience, such as point-of-care and home devices, as well as innovations that make current lab tests faster, more efficient, and more widely accessible.
Yes, new tests development through RADx Tech will be validated, proved clinically effective, and obtain Emergency Use Authorization (EUA) and/or clearance through the FDA.
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 initiative is focused on developing tests that can accurately detect the presence of SARS-CoV-2, the virus that causes COVID-19, in an individual. A combination test that detects virus 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 this RADx Tech initiative
The National Cancer Institute (NCI) intends to publish a Funding Opportunity Announcement (FOA) as a Request for Applications (RFAs) to solicit applications to establish Serological Sciences Centers of Excellence of collaborating investigators and an RFA for research projects. Specifically, both the Centers and the projects will identify and advance research opportunities to characterize the immune responses elicited by SARS-CoV-2 viral infection, especially as it relates to cancer patients. See NOT-CA-20-066 for more information
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.
Research teams 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 have specific milestones that need to be met before moving on to the next stage of review. The goal is to have three stages of review and several new tests available by late summer/fall 2020. The timeline may vary based on the risk and readiness level of each technology.
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.
Researchers will present their ideas to a panel of experts in the fields of infectious disease, diagnostics, engineering, manufacturing, and regulatory affairs. The experts will rapidly evaluate projects on a rolling basis. The projects with the most potential for success will be communicated to POCTRN leadership and move to a "shark tank" like process for further review and the opportunty to move to the next stage. Some advanced technologies may be able to skip the "shark tank" process.
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.
Does the applying project team need to do all the work to get the SARS-CoV-2 detection test in widespread use by the Fall?
RADx Tech has assembled a national network of expert technical, clinical, manufacturing, and regulatory advisors who will provide individualized assistance to project teams for project development and commercialization. NIBIB will provide financial and in-kind support to accelerate the entire product life cycle, from design to market, for projects that meet milestones successfully. 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.
Will only the projects that can meet the Project Review Criteria by late summer 2020 or soon thereafter be considered?
RADx Tech is committed to providing all selected projects with the necessary resources and support to meet the Project Review Criteria as quickly as possible to achieve the main objective of helping return America to normal during this unprecedented global pandemic. The timelines to complete expected milestones will be set according to the Proposed Solution Category; either “new”— innovative solutions that have the potential to meet the main objective of periodically testing all Americans, or “scale-up”— solutions that enable a significant increase in the throughput capacity of a test that is already in use (cleared by, or given Emergency Use Authorization by the FDA) and can be deployed before September. Project teams proposing “new” solutions are asked in the solicitation to identify the biggest risks in making the solution available in the fall of 2020 in a scalable way and how those risks can be managed.
The levels of analytical performance required will vary depending on the context of use, e.g., hospital settings vs. monitoring for new cases in the general population; therefore, NIH is not prescribing specific values. NIH expects that all tests receiving support will deliver a level of performance that is sufficient for decision-making under conditions in which the tests will be used.
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. It is anticipated that tests supported by RADx Tech 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.
Yes. NIH encourages all innovators to submit their promising ideas on how to rapidly accelerate diagnostic testing.
At this time there are no requirements to manufacture test components exclusively within 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 and move us directly into Work Package 2?
RADx Tech reviewers will review all information submitted in response to the solicitation and provide NIH with recommendations as to whether the proposed test can move directly to Phase 2. NIH may require independent validation of the test.
How can we have a plan to submit an EUA for a home-based test when the FDA does not have an EUA process yet for home-based SARS-CoV-2 detection tests?
NIH is actively working in partnership with the FDA to provide regulatory guidance to RADx Tech initiative project teams as necessary. If an EUA pathway is not available for a particular type of SARS-CoV-2 diagnostic test at the time the test has successfully completed the validation step, then the test will need to seek FDA clearance through established pathway(s).
It is too early to put a figure on the cost of each test. Applications for COVID-19 test designs must address materials and manufacturing costs, along with commercialization plans.
RADx Tech is supported by The Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139) enacted on April 24, 2020.
Information about this project and how to submit a proposal can be found on the POCTRN website.