FDA Issues Authorization to Report Genetic Variants of SARS-CoV-2
California-based Twist Bioscience Corporation received expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay on August 2, 2022, for the qualitative detection, identification, and differentiation of SARS-CoV-2 lineages and identification of specific genomic mutations.
This expanded FDA authorization builds on the initial EUA issued in March 2021 for qualitatively detecting the SARS-CoV-2 virus.
With the expanded authorization, the reporting of the identified and differentiated SARS-CoV-2 genetic mutations and viral lineages (e.g., Delta, Omicron) to clinicians is now authorized.
The authorization also allows for the reporting of individual mutations in patient samples.
"We developed this assay in the early days of the pandemic and, while useful for detecting the presence or absence of the virus, the true value lies in receiving a comprehensive sequencing report with all identified mutations that are now available under the expanded EUA," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience, in a press release.
"We believe this assay will continue to be critical to monitor the sequence evolution of SARS-CoV-2 and is another example of our commitment to provide tools to fight the pandemic, even when it becomes endemic."
New mutations in the SARS-CoV-2 virus continue to accumulate and circulate the world, creating genetic variants of concern that may alter transmissibility or vaccine efficacy.
'The virus will continue to evolve, and we expect this capture-based assay to serve as an important new tool for viral identification, sequencing, and surveillance.'
'With this expanded EUA, we anticipate that these data will, for the first time, now enable the appropriate treatment of COVID-19,' stated the company.
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