MICROGEM GRANTED EMERGENCY USE AUTHORIZATION FROM FDA FOR FAST POINT OF CARE PCR COVID-19 SALIVA TEST

The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is the nation's first point of care PCR saliva test for COVID-19 delivering results in minutes

CHARLOTTESVILLE, Va., April 19, 2024 /PRNewswire/ -- 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 the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, which provides polymerase chain reaction (PCR) results at the point of care in 27 minutes.

For instructions on how to use Sal6830, please click here.

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

The MicroGEM Sal6830 SARS-CoV-2 Saliva Test will bean 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 Systemmarks 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 Sal6830 SARS-CoV-2 Saliva Testwill 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.