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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.

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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