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Thermo Fisher Gets FDA Emergency Use Authorization for Pooled Sample SARS-CoV-2 Test Kit

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Thermo Fisher Scientific's TaqPath COVID-19 Pooling Kit.

The kit is designed to detect the ORF1ab, N, and S genes of SARS-CoV-2 in pooled samples containing up to five individual nasopharyngeal, oropharyngeal, anterior nasal, or mid-turbinate nasal swab specimens collected by healthcare providers. It runs on Thermo Fisher's Applied Biosystems QuantStudio 7 RT-PCR instrument and may be used by any lab that is CLIA-certified to perform high-complexity tests.

In April, Thermo Fisher received EUA from the FDA for a high-throughput, automated SARS-CoV-2 test kit, which is based on the Waltham, Massachusetts-based company's previously authorized Applied Biosystems TaqPath COVID-19 Combo Kit.