Visby Medical’s COVID-19 Rapid Test Gets Expanded EUA

The FDA has approved an expanded Emergency Use Authorization (EUA) for Visby Medical’s rapid polymerase chain reaction (PCR) COVID-19 test.

The new EUA allows the palm-sized test to be used by any organization that has a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. That means it can be used directly at the point-of-care.

Visby said that its rapid PCR test requires only a power plug and uses no additional instrument or reader to return results.