New saliva COVID-19 test receives Emergency Use Authorization from FDA

CHARLOTTESVILLE, Va. (WVIR) - A new type of COVID-19 test is hitting the market, and could change how we detect the virus.
MicroGEM, a Virginia-based molecular biology company with a Charlottesville office, is using its new saliva test to track COVID-19.
“It doesn’t require a technician who’s training to take a nasal swab, and it’s a more pleasant sample to contribute. It’s a non-invasive sample type,” MicroGEM VP Corporate Strategic Development and Investor Relations Peter Lee said Tuesday, April 19.
The company now has emergency-use authorization for its MicroGEM Sal6830 SARS-CoV-2 Saliva Test, which provides polymerase chain reaction (PCR) results at the point of care.
“There’s a lot of literature now that demonstrates that the saliva is also beneficial as a sample type, because the virus presents in a certain saliva sample earlier than it does in a nasal swab. And so if you’re trying to detect people who are potentially transmissible earlier, then saliva is really a great sample for that,” Lee said.
Lee says the PCR test remains the gold standard: “PCR tests are really what you want to use when you want a really confirmatory test that tells you not just... you’re more likely than than not, but that really it’s a diagnostic that will tell you close to definitively whether or not you’re infected,” he said.
This saliva test takes 27 minutes to get your results.
“We want them to be comfortable,” MicroGEM Sr. Director of Corporate Communications Lianne Landers said. “So if it’s a routine saliva test that makes it really easy for people to say, ‘yeah, I can embrace that.’ It’s so much easier.”
The company plans to roll out this test nationwide and hopes to apply the saliva test to other diseases down the road.
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