FDA Grants EUA for CRISPR-Based SARS-CoV-2 Assay
The test aims to help CLIA labs boost testing capacity
Rachel Muenz is the managing editor of G2 Intelligence and was previously senior digital content editor at Lab Manager, a publication dedicated to teaching lab professionals the management skills they need to run their laboratories as effectively as possible. She has more than 10 years of experience as a writer, editor, and curator of both print and digital content, with the majority focused on laboratory topics. Rachel holds an honors bachelor of arts degree in English from the University of Toronto and a diploma in journalism from Centennial College. Rachel regularly contributes news and insights to Today's Clinical Lab.
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Short-staffed CLIA laboratories now have another high-throughput tool at their disposal in the fight against COVID-19. On January 24, Mammoth Biosciences announced that its CRISPR-based SARS-CoV-2 assay, developed through a partnership with Agilent Technologies, recently received emergency use authorization (EUA) from the U.S. FDA.
The platform combines Mammoth’s DETECTR BOOST® SARS-CoV-2 Reagent Kit with Agilent’s Bravo BenchCel DB liquid handling platform to detect SARS-CoV-2 RNA in oropharyngeal, mid-turbinate nasal, anterior nasal, and nasopharyngeal swab specimens from people suspected of having COVID-19.
According to Mammoth’s website, clinical labs will be able to perform thousands of these tests per day, saving big on labor. The company adds that the high throughput assay performs just as well as current gold-standard PCR tests for SARS-CoV-2.
To learn more about CRISPR-based diagnostic platforms, download our free infographic.
“Mammoth’s DETECTR BOOST® SARS-CoV-2 assay rivals best-in-class PCR performance and this emergency use authorization is another important step toward our mission to harness the full potential of CRISPR to improve lives,” said Janice Chen, PhD, co-founder and CTO of Mammoth Biosciences, in a statement.
This isn’t the first CRISPR-based SARS-CoV-2 test to receive emergency approval by the FDA. In July 2021, Mammoth received EUA for its SARS-CoV-2 DETECTR Reagent Kit and Sherlock BioSciences was the first company to receive FDA EUA for a CRISPR-based COVID-19 test when it received emergency authorization for its Sherlock CRISPR SARS-CoV-2 Kit in January 2021.
To learn more, and see other recent FDA EUAs and approvals, read the full article in Laboratory Industry Report, a publication from G2 Intelligence, Clinical Lab Manager’s sister brand.