MicroGEM granted EUA for Covid-19 PCR Saliva test

The MicroGEM Saliva test is the first point of care PCR saliva test for Covid-19 delivering results in minutes

MicroGEM has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, which provides polymerase chain reaction (PCR) results at the point of care in 27 minutes.

The MicroGEM Sal6830 SARS-CoV-2 Saliva 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 MicroGEM Saliva Test has proven to be robust through the viral mutations that have occurred.

"The MicroGEM Saliva Test will be an essential testing tool in our ongoing efforts to get our nation's communities and businesses back to regular operations," said MicroGEM CEO Jeff Chapman. "The introduction of the MicroGEM Sal6830 Point of Care PCR System marks a historic step in our mission to democratize molecular diagnostics by moving ultra-fast, high-performance testing out of laboratories and closer to people at the point of need, thus allowing decisions to be made in real time."

"The MicroGEM Saliva Test will be an invaluable tool for testing children without scaring them with a stick up their nose." said Vanessa Mills, RN, BSN, MPH and COO of Care 4 U (C4UCHC), a Miami, Florida-based community health center providing primary medical care including HIV/STD screening, Covid-19 testing and vaccines, and other medical services regardless of ability to pay or insurance status. "The ability to reliably and quickly test all patients who present with Covid-19 symptoms is a game-changer for our clinics, allowing us to ensure care for people at the moment they need it."