FDA approves CRISPR-based COVID-19 test

Jan. 25, 2022

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Mammoth Biosciences for a high-throughput CRISPR-based COVID-19 test.

The test is the DETECTR BOOST SARS-CoV-2 Reagent Kit, and the FDA authorized it for labs that perform high-complexity testing.

The assay is designed to run on the DETECTR BOOST platform, which is a CRISPR-based molecular diagnostic system with automated liquid handling equipment. The high-throughput platform can perform “thousands” of tests per day, Mammoth, based in Brisbane, CA, said, “with PCR-equivalent performance and minimal hands-on time.”

This project is supported by the NIH Rapid Acceleration of Diagnostics (RADx) program of the National Institutes of Health (NIH) and has been funded in part with funds from the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health (NIH).

In January 2021, Mammoth Biosciences announced a co-marketing agreement with Agilent Technologies, based in Santa Clara, CA, to support the launch of the SARS-CoV-2 solution. The arrangement combines Mammoth’s DETECTR Boost assay with Agilent’s Bravo automated liquid handling workstation, including the Bravo BenchCel DB Workstation and BioTek plate readers.

Agilent was launched as a spinoff from Hewlett-Packard Company in 1999.

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