First home-collected saliva sample kit for COVID-19 testing gets FDA nod

First home-collected saliva sample kit for COVID-19 testing gets FDA nod

Just a few hours ago the FDA greenlighted the first home-collected saliva sample for COVID-19. Rutgers Clinical Genomics Laboratory, which already landed an EUA in mid-April for its test, can now expand its efforts to include test kits for home collection.

Patients do so using a specially designed collection device. This sample is then sent off to the Rutgers Clinical Genomics Laboratory in a sealed package.

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” FDA Commissioner Dr. Stephen M. Hahn, said in a release. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”




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