Truvian Sciences, a healthcare company at the intersection of diagnostics and consumer tech, has received federal emergency approval for its COVID-19 antibodies.
Truvian's Easy Check can test for COVID-19 antibodies in under 10 minutes and has agreements with U.S.-based manufacturers to produce its Easy Check COVID-19 kits at mass scale.
"Truvian's Easy Check performed exceptionally well, with a robust sample set, in both our own studies, as well as the studies conducted by independent laboratories," said Jeff Hawkins, President and Chief Executive Officer, Truvian Sciences. "With its consistent reproducibility, we are confident our testing solution, backed by the FDA's EUA, will set a higher bar for COVID-19 antibody testing."
The test was validated by UC San Diego, the University of Chicago and the Frederick National Laboratory for Cancer Research.
It exceeded the FDA accuracy requirements by correctly detecting the presence of COVID-19 antibodies in 98.44 percent of positive samples and correctly finding no antibodies in 98.9 percent of negative samples.
FDA Emergency Use Authorization will allow the test to be performed in healthcare labs. Truvian is also seeking a second authorization that will enable Easy Check to be used outside of centralized medical facilities such as workplaces and pop-up testing sites. Cost is $15 per test.