FDA Authorizes First COVID-19 Test Using Saliva Collected at Home

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only. To be clear, this isn't the first test the agency has authorized with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers' test previously had been added to FDA's high-complexity molecular-based LDT "umbrella" emergency use authorization to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDNA-1000 saliva collection device. Last month FDA authorized the first diagnostic test with a home-collection option, but that test uses a sample collected from the patient's nose with a nasal swab and saline. That authorization is for LabCorp's COVID-19 RT-PCR test using samples patients collect themselves with LabCorp's Pixel home collection kit. “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,” said FDA Commissioner Stephen Hahn, MD. “We will continue to work around the clock to support the developm...
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 IVD Source Type: news