Audere’s COVID-19 Test Gets FDA’s Emergency Use Authorization

Audere has received an Emergency Use Authorization from the FDA for its HealthPulse@home Fusion test for COVID-19.

The collection kit is authorized for collection of anterior nasal swab specimens at home or in a healthcare setting when determined to be appropriate by a healthcare provider.

The test is for use by individuals age 16 and up, as well as children age two to 15 with adult assistance, whether or not they have symptoms of COVID-19.

The collected samples can be transported at ambient temperature for analysis at a laboratory that is certified to perform high-complexity tests, the agency said.