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FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for an RT-PCR-based SARS-CoV-2 test developed by Northeastern University's Life Sciences Testing Center.

The Life Sciences Testing Center COVID-19 Test is designed to detect the SARS-CoV-2 N, ORF1ab, and S genes in anterior nasal specimens self-collected using the Life Sciences Testing Center COVID-19 Home Collection Kit.

The test uses the authorized Thermo Fisher Scientific TaqPath COVID-19 Combo Kit and runs on Thermo Fisher's Applied Biosystems 7500 Fast Dx system. The test may only be used by the Life Sciences Testing Center, according to the FDA.