FDA Grants EUA to Genabio’s COVID-19 Test Kit

The FDA has granted Emergency Use Authorization (EUA) to Bedford, Mass.-based Genabio Diagnostics’ COVID-19 rapid antigen self-test kit.

The test is authorized for non-prescription home use for detection of antigens from the SARS-CoV-2 virus from anterior nasal swab samples. It is for use in symptomatic patients within the first seven days of the onset of symptoms and for individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection.

The EUA allows individuals 14 years and older to self-collect nasal swab samples, while samples for individuals two to 13 years old must be collected by an adult.

Under the EUA, the test must be administered twice, with 24-48 hours between each test.