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LabCorp Receives FDA Emergency Use Authorization for SARS-CoV-2 RNA Extraction Method

NEW YORK – Laboratory Corporation of America said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for an RNA extraction method for use in SARS-CoV-2 testing.

According to the Burlington, North Carolina-based company, the method uses heat to trap viral particles, which eliminates the need to use RNA extraction reagents to capture viral nucleic acid for testing, improving turnaround time and reducing reliance on extraction reagents, which have proved a supply chain bottleneck at points in the pandemic.

LabCorp also said the FDA reissued an EUA for the use of matrixed pooling of samples collected via its Pixel by LabCorp and LabCorp at Home COVID-19 test collection kits. The move is the reissuance of an earlier reissued EUA In July allowing LabCorp to pool samples collected by a healthcare professional.

"Innovation and scientific advancements will ultimately resolve this public health crisis," Marcia Eisenberg, chief scientific officer of LabCorp Diagnostics, said in a statement. "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."

The company noted it has performed more than 15 million molecular tests for SARS-CoV-2 and can process 200,000 tests per day. It plans to increase capacity further, it added.