EUA builds on early approval for home nose swab test

WASHINGTON — The FDA has issued an emergency use authorization (EUA) for a home Covid-19 saliva test to Rutgers Clinical Genomic Laboratory.

The authorization is limited to tests performed at Rutgers’ lab “using their molecular [laboratory developed test (LDT)] Covid-19 authorized test for saliva specimens collected using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device,” the agency explained in a statement.

The home option enables patients to collect their saliva sample and then return it to the lab in a sealed package for testing. Rutgers’ lab is the only lab authorized to use saliva samples to test for SARS-CoV-2 thus far. In order to get the tests, patients must have a doctor’s prescription.

“It is important to note that this is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home,” the agency wrote.

Last month, the agency authorized the first home testing option to LabCorp for its RT-PCR nasal swab test.

“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 M. Hahn, MD.

Hahn noted that, so far, the FDA has granted EUAs to more than 80 tests for Covid-19 and adding home testing options “is an important advancement in diagnostic testing during this public health emergency.”

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,520,926,192,927,151,725,928,925,934