As government and health care officials plead for expanded access to high-speed COVID-19 tests, health care companies across the country began mobilizing their resources to meet the growing demands with direct-to-consumer kits.
The benefits of such kits could be substantial, allowing everyday people to test themselves for COVID-19 in the privacy of their homes instead of visiting a hospital, potentially exposing health care workers and other healthy individuals. If the test came back negative, it could allow them to go back to work without fear of infecting others.
But the path to commercialization has been a bumpy one. On March 16, the Food and Drug Administration issued new, loosened guidelines meant to help accelerate the availability of different types of COVID-19 diagnostic tests. Under the new policy, laboratories approved by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA) were allowed to manufacture and distribute a validated COVID-19 test for 15 days before submitting official Emergency Use Authorization from the FDA.