NGS COVID-19 test receives FDA EUA

March 29, 2021

Twist Bioscience, which specializes in synthetic DNA, received emergency use authorization (EUA) from the from the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay, according to a news release.

The test uses proprietary analytical software for infectious disease diagnostics from Biotia, a company that leverages sequencing-based technology and proprietary AI-powered software to identify microorganisms and antimicrobial resistance.

The SARS-CoV-2 NGS Assay is an in vitro diagnostic test, a highly sensitive nucleic acid hybridization capture-based assay, intended for the detection of SARS-CoV-2 RNA.

The SARS-CoV-2 NGS Assay analyzes the entire RNA viral sequence, to determine the presence or absence of the virus. The company contends that that hybridization capture-based approach utilized in this assay maximizes the number of genetic variants identified, where other sequencing methods may miss mutations in certain regions.

New mutations in the SARS-CoV-2 virus continue to accumulate and circulate around the world, creating genetic variants of concern that may alter virus transmission or vaccine efficacy, including the most recent B.1.1.7, B.1.351, and P.1 lineages initially found in the United Kingdom, South Africa, and Brazil respectively.

“While there are many available high-throughput diagnostic tests available for COVID-19, our solution enables clinicians and researchers the ability to sequence and surveil the evolution of mutations in the virus over time and geography. This is especially significant at the moment as more variants are identified that are more contagious,” said Emily M. Leproust, PhD, CEO and Co-founder of Twist Bioscience. “Importantly, while many labs are conducting individual sequencing runs for each patient sample, this assay and the accompanying software provide a way to batch about 100 samples together, providing actionable information that can then be used to inform public health and clinical decisions.”

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