The U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) to Verily Life Sciences, a subsidiary of Alphabet, for a RT-PCR test to detect SARS-CoV-2 as well as for a pooled sampling technique, according to an approval letter from the FDA.
In its letter to Verily, the FDA said the EUA was for the qualitative detection of nucleic acid from SARS-CoV-2 in upper-respiratory specimens as well as for the pooled testing of up to 12 specimens collected by healthcare providers. The EUA is limited to testing at CLIA-certified Verily Life Sciences Laboratory in South San Francisco.
Verily said it verified the performance of the RT-PCR test in its lab with Thermo Fisher Scientific’s TaqPath test kit.
Verily, a sister company to Google, also has said the lab’s services will be primarily be focused on customers of Verily’s Healthy at Work program, which integrates SARS-CoV-2 testing, symptom screening, population analytics and ongoing safety controls to help companies manage the reopening of shared workspaces.
Earlier this year, Verily also launched the Baseline COVID-19 testing program in conjunction with the state of California, as an integrated solution combining symptom reporting, specimen collection, testing and reporting of results. Since then, the program has expanded to other states, including Connecticut, Delaware, Idaho, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Virginia and Washington.
