BioPharma, Diagnostics

Mammoth Biosciences, GSK partner on CRISPR-based Covid-19 diagnostic

The companies plan to apply with the Food and Drug Administration for an emergency use authorization by the end of the year. Mammoth's technology is based on the research of CRISPR pioneer Jennifer Doudna.

dna, genomics

Two weeks after the Food and Drug Administration granted its first-ever authorization to a product based on CRISPR, in the form of a diagnostic test for SARS-CoV-2, another firm is partnering with a large drugmaker to develop a rapid test for the Covid-19 virus using the technology.

South San Francisco, California-based Mammoth Biosciences said Wednesday that it had entered a deal with British drugmaker GlaxoSmithKline’s consumer health division to develop a handheld, disposable test based on the former company’s CRISPR-based DETECTR platform. The test is designed to identify the presence of viral RNA strands from a nasal swab and deliver point-of-use results in less than 20 minutes. Financial terms of the deal were not disclosed.

On May 7, the FDA granted an emergency use authorization for Cambridge, Massachusetts-based Sherlock Biosciences’ CRISPR diagnostic test for Covid-19, marking the first time the agency had given any kind of authorization to a CRISPR-based product. Sherlock’s test is based on the research of Broad Institute scientist Feng Zhang, while Mammoth’s is based on the research of University of California Berkeley scientist Jennifer Doudna. Both are considered pioneers of CRISPR gene editing technology.

In a phone interview, Mammoth CEO Trevor Martin noted the company plans to file for an EUA for the test by the end of the year, but the companies plan to branch out beyond Covid-19 as well.

“Covid-19 is the urgent area where we hope we can have an impact, so that’s the initial focus,” Martin said. “We have the opportunity together to explore a variety of targets that this type of platform could be leveraged for.”

Other targets could include diseases common in developed countries as well as those prevalent in the developing world like Zika and Ebola viruses, Martin added.

Mammoth said it would initially develop the test initially for use in clinical settings, but eventually for consumers at home. Martin said use by consumers could come in the form of direct-to-consumer sales or having patients initially go into the doctor’s office.

“We definitely want to work closely with organizations like the FDA to make sure that this is something that’s easy to use and make sure that it’s validated,” he said.

DETECTR itself is under review for an EUA and was the subject of an April 16 paper in the journal Nature Biotechnology. Using samples from 36 patients with Covid-19 and 42 with other viral respiratory infections, researchers from Mammoth, the University of California San Francisco and the California Department of Public Health found that compared with industry-standard RT-PCR assays, DETECTR had 95% positive predictive agreement and 100% negative predictive agreement.

Photo: iLexx, Getty Images

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