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NIH is investing $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with the FDA. NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing.

The NIH RADx initiative announced today that it has issued contract awards totaling $77.7 million to develop and manufacture 12 new rapid diagnostic tests for SARS-CoV-2, the virus that causes COVID-19. The home and point-of-care testing platforms target the need for high-performance, low-cost home tests and point-of-care tests that can potentially detect multiple respiratory infections.

NIBIB selected three winning teams for designs that excel according to four criteria: the significance of the problem being addressed; the impact on clinical care; the innovation of the design; and the ideation process or existence of a working prototype.

In a study that compares rapid antigen and laboratory PCR approaches for COVID-19 serial screening, researchers affiliated with the NIH RADx initiative reported results from 43 people infected with the virus.

NIH researchers report that the prevalence of COVID-19 in the United States during spring and summer of 2020 far exceeded the known number of cases. For every diagnosed COVID-19 case in this time frame, the researchers estimate that there were 4.8 undiagnosed cases, representing an additional 16.8 million cases by July alone.

The CDC, in collaboration with the NIH, has launched an innovative community health initiative called “Say Yes! COVID Test.” Up to 160,000 residents in two US communities will have access to free, rapid antigen tests that they can administer themselves to use three times a week for one month.

An NIH-funded research team has launched a study to assess performance and usability of a smartphone app paired with the Quidel QuickVue At-Home COVID-19 Test, which received FDA emergency use authorization for use with a prescription.

The FDA granted emergency use authorization today for an innovative COVID-19 viral antigen test developed with support from the NIH RADx Initiative.

The COVID-19 Testing Impact Calculator is a free resource that shows how different approaches to testing and other mitigation measures, such as mask use, can curb the spread of the virus in any organization.