The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT).
The action allows the testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19,” FDA Commissioner Stephen M. Hahn said. “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. We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic.”
Hahn said the FDA has authorized more than 80 COVID-19 tests and noted adding more options for at-home sample collection is an important advancement in diagnostic testing during the pandemic.
The testing process, per the FDA, involves patients collecting a saliva sample and returning it to the Rutgers Clinical Genomics Laboratory in a sealed package for testing.
The Rutgers Clinical Genomics Laboratory test is currently the only authorized COVID-19 diagnostic test that uses saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19. The test remains prescription only.