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LabCorp Gets First FDA Greenlight for SARS-CoV-2 Differentiation Test

by | Jun 14, 2022 | Articles, News, Open Content

For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.

Multianalyte lab tests capable of identifying and differentiating the SARS-CoV-2 virus that causes coronavirus from other respiratory viruses have become common. But now for the first time, the FDA has granted emergency use authorization (EUA) for a test to differentiate strains of the SARS-CoV-2 virus.

The test, Laboratory Corporation of America’s VirSeq SARS-CoV-2 NGS Test, runs on the PacBio Sequel II NGS system using samples from patients that test positive for SARS-CoV-2 using LabCorp’s COVID-19 RT-PCR Test or SARS-CoV-2 & Influenza A/B Assay.

In announcing the EUA on June 10, the FDA noted that the purpose of the VirSeq SARS-CoV-2 NGS Test is not to aid in primary diagnosis or confirm the presence of SARS-CoV-2. Nor is the test designed to identify new genetic mutations of SARS-CoV-2. Rather, its objective is purely to determine which strain of the virus the patient has.   


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