Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more