FAQs - RADx Tech High Performance Tests
Frequently Asked Questions
General application questions
Question: How will redesigned or new tests be developed?
Answer: Projects will follow a staged, milestone-driven approach for development. Ideas will be rapidly reviewed and assessed for support. Projects that are funded will also receive in-kind resources to maximally accelerate progress. NIH will closely monitor progress of each project, and future support will be dependent upon achieving stated milestones.
Question: Is the goal of the program to facilitate authorization/clearance of improved COVID-19 tests by the U.S. Food and Drug Administration (FDA)?
Answer: Yes, the ultimate goal is to have new or redesigned tests meet the regulatory requirements to obtain Emergency Use Authorization (EUA) and/or 510(k) clearance through the U.S. Food and Drug Administration (FDA).
Question: Is obtaining FDA clearance necessary before the test can be deployed?
Answer: Yes. FDA authorization/clearance is required for tests to be marketed in the U.S.
Question: How are confidentiality and intellectual property handled?
Answer: 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 applies to all NIH research and development funding granted to for-profit organizations regardless of size and all non-profit entities.
Question: Can applicants from outside the U.S. apply?
Answer: Yes. NIH encourages all innovators to submit their promising ideas on how to improve tests.
Question: Can diagnostic test components be manufactured outside the U.S.?
Answer: At this time there are no requirements that test supplies and components be manufactured exclusively within the U.S.
Question: Do plans for marketing have to include the U.S.?
Answer: Yes, project teams must plan to market and deploy the test within the U.S.
Question: Does my device have to be a COVID-19 test? Can it be a component/reader etc.?
Answer: There is no provision for components in this solicitation. If you have a component product that you’d like to develop we might suggest partnering with an assay developer and applying as a team.
Question: Can companies developing a multiplex test apply?
Answer: Yes, but the test must detect COVID-19 and meet the other submission criteria.
Question: Will funding be supported for clinical testing/trials?
Answer: Yes, limited funding for clinical testing/trials will be available as part of the work packages developed by projects that reach this stage. For example, funds could be used to support a small clinical trial to support an EUA submission to the FDA. Larger trials required for a 510(k)-clearance submission are expected to be supported by the applicants themselves.
Question: Does an applicant have to be a current RADx company to apply?
Answer: No, this is an open solicitation.
Question: If my company is already in the RADx portfolio, can I still apply?
Answer: Yes, current and past RADx awarded companies may apply to the new solicitations.
Question: Can companies apply to both the RADx High Performance Test program and RADx Tech Accessible Test program.
Answer: Yes, companies can submit a separate application to each program. Solutions should address defined unmet needs for each solicitation.
Questions Specific to Development of Accessible Tests
Question: What is the RADx Accessible Tests Program?
Answer: The RADx Accessible Tests program was established to accelerate the development of over-the-counter (OTC) COVID-19 diagnostic technologies that can be used independently by people with disabilities (e.g., blindness, low vision, fine motor skill difficulties, and aging-related disabilities).
Question: What are the unmet needs?
Answer: Throughout the pandemic, there has been an increased focus on the development and production of COVID-19 diagnostic tests for at-home use to help combat the spread of the virus. However, home users can have a large range of physical and sensory challenges that should be considered in the test design. Currently, most tests on the market make heavy use of visual information with no alternative modalities such as auditory or haptic feedback available, inhibiting independent use by people with no or low vision. Many tests use small components, require precise manipulations, and/or require significant force for one or more steps, creating additional challenges for users with fine motor control impairments or reduced hand strength. As a result, independent use of OTC tests for people with disabilities can be challenging or impossible. New or redesigned OTC tests to support accessible use are needed. Please find additional resources about the inaccessibility of current, at-home COVID-19 tests.
Question: What would be an example of a proposal that meets accessibility needs for the RADx Tech Accessible Test program?
Answer: A product that incorporates design elements and functionality that allows greater usability for individuals with disabilities including but not limited to blind/low vision, fine motor skill impairments, and aging populations.
Applications that highlight a product that does not rely on smart technology (i.e., smart phones, computers, expensive readers) are strongly encouraged as many users do not have smart technology or cannot use smart technology. Applications that highlight a product that increases accessibility across various disabilities are also encouraged.
Question: Are these tests intended to be produced only for people with disabilities?
Answer: New and redesigned products should be easier to use for everyone. While the objective is to create tests that are accessible to people with disabilities, these design improvements will also benefit the non-disabled population using them. For example, a test with fewer, easier-to-manipulate parts, or simplified instructions with larger print could improve the test experience for all users.
Question: How much will the new or redesigned OTC tests cost?
Answer: Test costs should be competitive with similar products currently on the market. Applications must address materials and manufacturing costs, along with commercialization plans.