LabCorp’s Innovative SARS-CoV-2 RNA Extraction Method Secures FDA Emergency Use Authorization

LabCorp Diagnostics (Burlington, NC, USA) has become the first commercial laboratory to receive an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a new, high-throughput method that uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing.

The latest authorization builds on a long line of testing firsts for LabCorp as a commercial lab, such as: first FDA EUA for RT-PCR testing (March 5), first FDA EUA for at-home collection (April 20), first online consumer-initiated antibody testing, first digital service for physician-initiated patient collection (LabCorp At Home, July 7), first FDA EUA for asymptomatic testing and matrixed pool testing (July 24), and first combined test for multiple respiratory infections including COVID-19 and flu (September 8).

The latest authorization will help the company improve the speed and efficiency of RT-PCR tests, considered the ‘gold standard’ for active infections. The innovative heat extraction process, which has comparable sensitivity to current extraction methods, traps viral particles, eliminating the need for RNA extraction reagents to capture and concentrate viral nucleic acid. This substantially improves testing efficiency and decreases LabCorp’s reliance on testing supplies - streamlining resources and further reducing the time needed to complete and report results for molecular tests. LabCorp has performed over 15 million molecular tests since first making the COVID-19 test available in March and is now able to process 200,000 tests per day with plans to increase capacity further.

“Innovation and scientific advancements will ultimately resolve this public health crisis,” said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. “We are constantly evaluating new technologies and methods to improve the testing process, and we are excited to pioneer and introduce RNA-extraction free methodology in our laboratories, and to the diagnostic community at large.”

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