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January 25, 2022

FDA grants EUA to Mammoth Biosciences’ Covid-19 molecular assay

The new test kit has the capability to perform thousands of tests a day with minimal user interaction.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) to Mammoth Biosciences’ new CRISPR-based SARS-CoV-2 molecular assay, named DETECTR BOOST SARS-CoV-2 Reagent Kit.

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Together with the Agilent Bravo BenchCel DB liquid handling platform, the new kit is designed to detect SARS-CoV-2 RNA from anterior nasal, nasopharyngeal, mid-turbinate nasal or oropharyngeal swab samples.

It is intended for use by individuals who are suspected of having contracted Covid-19 by their healthcare providers.

The DETECTR BOOST SARS-CoV-2 Reagent Kit is claimed to be the first CRISPR-based high-throughput Covid-19 test that combines CRISPR with laboratory automation in order to test for the SARS-CoV-2 virus.

The company stated that the test is carried out in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA).

The new test kit has the capability to perform thousands of tests a day with minimal user interaction.

Mammoth Biosciences chief technology officer and co-founder Janice Chen said: “Mammoth’s DETECTR BOOST SARS-CoV-2 assay rivals best-in-class PCR performance and this EUA is another important step towards our mission to harness the full potential of CRISPR to improve lives.

“We are proud of the team, our partners and sponsors for their commitment to developing novel testing solutions to address the Covid-19 pandemic.”

The company said that the new test project is supported by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) programme.

It has been partly funded with federal funds obtained from the NIH, Department of Health and Human Services, and National Institute of Biomedical Imaging and Bioengineering.

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Navigate your business through the ‘new normal’

COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
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