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Exact Sciences Receives FDA EUA for SARS-CoV-2 Diagnostic

NEW YORK – Exact Sciences has received a letter from the US Food and Drug Administration granting it Emergency Use Authorization for an in vitro diagnostic assay for the detection of SARS-CoV-2.

The SARS-CoV-2 RT-PCR assay test, which will be performed at Exact's CLIA-certified lab, is a real-time PCR assay intended for the qualitative detection of the virus' nucleic acids in nasal, nasopharyngeal, and oropharyngeal patient swabs.

According to the FDA, the assay uses Seegene's Allplex 2019-nCoV Assay Kit real-time reverse transcription polymerase chain reaction kit. The primer and probe sets are designed to detect the virus's E, N, and RdRP genes. RNA extraction is conducted using Promega's Maxwell RSC Viral Total Nucleic Acid Purification Kit on the Maxwell RSC 48 Instrument for nucleic acid extraction, and the test is designed to run on the Thermo Fisher Scientific Applied Biosystems QuantStudio 5 real-time PCR system for cDNA synthesis and PCR amplification of the target sequences.

At the end of March, Exact joined Promega and other institutions in a public-private partnership initiated by the State of Wisconsin to increase its laboratory testing capacity for COVID-19. At the time, Exact Chairman and CEO Kevin Conroy said that the company was repurposing some of its existing equipment and reconfiguring areas of its laboratory space to help scale up Wisconsin's COVID-19 testing capabilities. The company said in an email that it was planning to be able to process hundreds of tests in the near term, ramping up to thousands of tests in the coming weeks.