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Yale School of Public Health Granted EUA for COVID-19 Saliva Test

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The SalivaDirect test stands out because it doesn’t require a separate nucleic acid extraction step.

FDA has given emergency use authorization to a saliva-based test to detect COVID-19. The SalivaDirect COVID-19 diagnostic was developed by researchers at the Yale School of Public Health.

SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container. FDA noted the test doesn’t require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources.

“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen Hahn, M.D., said in a release. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America. FDA encourages test developers to work with the agency to create innovative, effective products to help address the COVID-19 pandemic and to increase capacity and efficiency in testing.”

This isn’t the first saliva-based test that has been granted EUA from FDA. In April, MD+DI reported a test developed by Rutgers’s RUCDR Infinite Biologics and collaborators won EUA.

Rutgers said the tests are available to the RWJBarnabas Health network, including Robert Wood Johnson University Hospital, University Hospital in Newark and many other facilities, including several county health departments.

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