Accelerated review pathway helps bring pair of at-home COVID-19 tests to U.S. market

Two new COVID-19 home tests are now available to consumers in the U.S. Tests from SD Biosensor and Siemens in December gained Food and Drug Administration emergency use authorization, in part driven by the Department of Health and Human Services’ accelerated pathway to support FDA’s review of tests with potential for large-scale manufacturing. 
 
The SD Biosensor COVID-19 At-Home Test is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 or older, or adult-collected anterior nasal swab samples from individuals aged 2 or older. It should be noted that SD Biosensor’s test does not differentiate between SARS-CoV and SARS-CoV-2. The Siemens CLINITEST Rapid COVID-19 Antigen Self-Test for qualitative SARS-CoV-2 detection is designed for home use using self-collected anterior nasal swabs from individuals age 14 and older who are within the first seven days of COVID-19 symptom onset. The test is also authorized for those between the ages of 2 and 13 when an adult collects the nasal sample. Test results are available within 15 minutes of administration.