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Verily Life Sciences Coronavirus Test Gets FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for Verily Life Science's molecular SARS-CoV-2 test.

The Verily COVID-19 RT-PCR Test is designed to detect the ORF1ab, N, and S genes of SARS-CoV-2 in upper respiratory specimens and can be used with pooled samples containing up to 12 individual specimens collected by healthcare providers.

The test is a modified version of Thermo Fisher Scientific's authorized TaqPath COVID-19 Combo Kit that uses a matrix 2D-pooling strategy for which samples are pooled in a 96-well plate and includes procedural modifications that compensate for sample dilution during the pooled testing, according to the FDA.

RNA extraction is performed using Thermo Fisher's MagMax Viral/Pathogen Nucleic Acid Isolation Kit and KingFisher Flex Magnetic Particle Processor, and the test runs on Thermo Fisher's Applied Biosystems 7500 Dx Fast Real-Time PCR System or Applied Biosystems QuantStudio 5 Real-Time PCR System.

The test may be performed only by South San Francisco-based Verily, a sister company to Google. Both firms are owned parent company Alphabet.