Labcorp nabs EUA for new COVID-19 molecular test

By staff writers

October 5, 2020 -- The U.S. Food and Drug Administration (FDA) has awarded Labcorp emergency use authorization (EUA) for a new, high-throughput method that uses heat and technology to extract RNA from COVID-19 samples.

The method will improve the speed and efficiency of reverse transcription polymerase chain reaction (RT-PCR) tests, which are considered the gold standard. The heat extraction process traps viral particles and eliminates the need for RNA extraction reagents to capture and concentrate viral nucleic acid, which improves testing efficiency and cuts down on testing supplies.

The firm also announced it received an FDA EUA for the use of matrixed pooling on samples collected outside a healthcare setting via its Pixel by Labcorp and Labcorp At Home COVID-19 test kits. The matrixed pooling authorization for at-home collection is an extension of the FDA EUA issued on July 24.

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Last Updated ls 6/22/2021 4:11:17 PM