CLEVELAND (WYTV) – A first-of-its-kind COVID-19 testing method has been developed by a company in our region.
Cleveland medical clinic IdentifySensors Biologics has developed new technology for an at-home COVID-19 test.
The company said its saliva test is fast, accurate and inexpensive, and will soon go before the U.S. Food and Drug Administration for emergency approval.
Like the RT-PCR test, this test is molecular but uses a saliva sample instead.
“Ours is a self-test done at home without any of these other reagents,” said CEO Dr. Gregory Hummer. “You don’t need a machine, you don’t need a lab tech. It’s very inexpensive and it can be done daily as many times as you need to.”
A test reader with a sensor uses an electric current to detect COVID-19 from the sample. The test will use a Bluetooth signal to provide accurate results within minutes to users’ smartphones and to health agencies, as legally required.
“We’re expecting the accuracy to be the same as the gold standard, the RT-PCR test, which is 95% to 97% accurate,” Hummer said.
The company plans to seek emergency use authorization from the FDA within 30 to 60 days and with approval, the test may be available over the counter within six months.
IdentifySensors Biologics also plans to use the same technology to expand the test for other viruses, including influenza.