FDA authorizes Mammoth Bio's high-throughput CRISPR test for COVID-19

Mammoth Biosciences has secured an emergency authorization from the FDA for its high-throughput COVID-19 test, which is powered by CRISPR gene-editing enzymes.

The company—born out of the work by CRISPR pioneer and Nobel laureate Jennifer Doudna, Ph.D.—has been working for the past year with Agilent to develop a ready-to-use laboratory system that aims to provide screening accuracy rivaling gold-standard PCR tests but at much faster speeds.

While Mammoth has focused on tailoring its reagents to react with the coronavirus’s genome, Agilent has worked to deliver high-speed liquid handling hardware with its Bravo BenchCel DB workstation platform.

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The project has received support from the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative, with federal funding for its evaluation and scale-up. The lab test is designed to work with both nose and mouth swabs and aims to process thousands of samples per day.

The green light for the company’s automated DETECTR Boost diagnostic kit comes on the heels of a massive deal with Bayer, granting the drugmaker access to its CRISPR R&D tools in return for $40 million upfront and milestone options that could top $1 billion in payouts. That agreement followed a similarly structured $650 million contract with Vertex Pharmaceuticals last October.

RELATED: Vertex signs another Mammoth-sized CRISPR deal with $650M in biobucks on the line

Meanwhile, CRISPR test developer Sherlock Biosciences—which counts gene-editing patent rival Feng Zhang, Ph.D., among its team of co-founders—has been working to automate its COVID-19 rapid test, which received an FDA authorization in May 2020. 

That diagnostic is designed to supply a result in about an hour without requiring specialized lab equipment. In mid-2021, Sherlock reported it was working with NorDx Laboratories to study a high-throughput version of its test.

Both Sherlock's and Mammoth’s tests use the ability of CRISPR enzymes to identify genetic code specific to the coronavirus and then snip that code out of the sample through chemical reactions that can be read as a positive result.