FDA Watch: Mammoth Biosciences Garners EUA for CRISPR-Based SARS-CoV-2 Test

A significant development in COVID-19 test development occurred on Jan. 24, when the US Food and Drug Administration (FDA) announced that it has granted Emergency Use Authorization (EUA) for a high-throughput assay that uses CRISPR technology to detect the SARS-CoV-2 virus. The CRISPR-based assay provides PCR-equivalence performance but on a much more scalable and rapid basis, potentially making it ideal for use in screening asymptomatic populations. 

The Mammoth Biosciences DETECTR Kit

The DETECTR Boost SARS-CoV-2 Reagent Kit assay performs simultaneous reverse transcription and isothermal amplification using loop-mediated amplification (RT-LAMP) for RNA extracted from oral or nasal swabs, with a total run time of 15 minutes. The test was developed by Mammoth Biosciences, a San Francisco-based biotech company founded in 2017 by CRISPR pioneer Jennifer Doudna and colleagues from the University of California, Berkeley.

The DETECTR test is the product of a year-long collaboration between Mammoth and Agilent. The strategy: Tailor Mammoth’s CRISPR enzymes for identifying genetic codes to react with and identify the SARS-CoV-2 virus genome while Agilent leverages its Bravo BenchCel DB workstation platform to deliver high-speed liquid handling hardware to develop a test that can process more than 4,000 samples per day.

Financing & Marketing

Mammoth raised $195 million in Series C and D financing rounds in Sept. 2021. The project has also received federal funding through the National Institutes of Health’s Rapid Acceleration of Diagnostics Initiative, as well as the Department of Health and Human Services.

Mammoth and Agilent will launch the test under a comarketing agreement signed last January “This partnership will help address the need for more widespread testing options for COVID-19, helping to fill the gap in the market as testing labs run into supply issues or reach capacity,” noted Mammoth CEO Trevor Martin in a statement issued when the comarketing deal with Agilent was announced.

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This article originally appeared in G2 Intelligence, Laboratory Industry Report, February 2022.