MicroGEM US Inc., a Virginia-based molecular biology company, has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for its MicroGEM Sal6830 SARS-CoV-2 Saliva Test, which provides polymerase chain reaction (PCR) results at the point of care in 27 minutes.
With this authorization, MicroGEM will begin manufacturing the test kits at its large production facility in Ogden, the company said.
MicroGEM said the new test is the first FDA emergency use-authorized saliva test for SARS-CoV-2 using PCR directly at the point of care where people can wait for fast results after providing a sample. Clinically tested during both the Delta and Omicron waves of the pandemic, the test has proven to be accurate through the viral mutations that have occurred.