FDA Grants EUA to Predicine’s Pooled COVID-19 Test

The FDA has granted an Emergency Use Authorization (EUA) for Predicine’s SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) test.

The test can be used for pooled samples containing up to eight individual anterior nasal swab specimens collected dry from individuals with or without symptoms or other reasons to suspect SARS-CoV-2.

The EUA allows for self-collection — including at home — of samples by people aged 18 years and older, self-collection under adult supervision in individuals 14 years and older, and collection with adult assistance in individuals two years and older.

Analysis of the samples is limited to Predicine’s Hayward, Calif. laboratory.