LabCorp Heat Extraction COVID-19 Test Method Gets FDA's EUA

 | Oct 05, 2020 01:28AM ET

Laboratory Corporation of America (NYSE:LH) Holdings or LabCorp LH recently received a new Emergency Use Authorization (EUA) from the FDA for its new COVID-19 test that uses heat extraction process instead traditional reagents for RNA extraction in the testing method. This new, high-throughput method reduces the company’s supply chain dependency, improving the turnaround time and efficiency of its RT-PCR tests.

LabCorp claims to be the first commercial laboratory to receive a EUA for this kind of technique.

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According to LabCorp, this 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 significantly improves accuracy of the testing by streamlining resources and reducing the time to complete the testing procedure and report results. The method also adds to other existing LabCorp molecular tests, such as its short nasal swab for at-home collection. To note, LabCorp’s current average result delivery time for COVID-19 molecular tests is 24 hours.

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In the same press release, the company noted that as the first commercial laboratory, it received the FDA’s EUA for use of matrixed pooling on samples collected outside a healthcare setting via its Pixel by LabCorp and LabCorp At Home COVID-19 test collection kits. This latest EUA for matrixed pooling is an extension of the EUA issued in July. This enabled LabCorp to increase testing capacity at lower turnaround time.