Are the tests FDA approved?

BASE10’s COVID-19 tests are FDA validated with testing performance that consistently exceeds FDA performance requirements.

The FDA’s rigorous validation process includes four clinical studies with more than 500 patients in three different countries. All BASE10 COVID-19 tests were tested in an FDA lab and have been independently confirmed through BASE10’s collaboration with the FDA and other federal research labs, acquiring the high complexity CLIA lab certificate for test performance.