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Mammoth Biosciences, GSK Developing CRISPR-Based SARS-CoV-2 Diagnostic for Home Testing

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NEW YORK – Mammoth Biosciences said on Wednesday that it has signed a collaboration deal with the consumer healthcare arm of pharmaceutical company GlaxoSmithKline to develop a CRISPR-based SARS-CoV-2 diagnostic test for use by consumers at home and healthcare providers in clinics.

The partners plan to use Mammoth's DNA Endonuclease-Targeted CRISPR Trans Reporter (DETECTR) platform, which can identify and signal the presence of viral RNA in a sample obtained through a nasal swab.

Mammoth has been developing its DETECTR disease detection platform since it came out of stealth mode in 2018, using Cas12 and Cas13 to look for DNA and RNA to detect various diseases. It delivers results on lateral flow strips, similar to at-home pregnancy tests.

Last month, the biotech company — which was cofounded in 2018 by University of California, Berkeley CRISPR researcher Jennifer Doudna — published a study in collaboration with the University of California, San Francisco's Charles Chiu describing the DETECTR-based SARS-CoV-2 test.

At the time, the researchers said their CRISPR-Cas12-based lateral flow assay could be run in 30 to 45 minutes and demonstrated 95 percent positive predictive agreement and 100 percent negative predictive agreement with qRT-PCR tests. They validated their method using contrived reference samples and clinical samples from patients in the US.

The test is a faster alternative to most PCR-based tests, which can take four to six hours to run — including the US Centers for Disease Control and Prevention SARS-CoV-2 real-time RT-PCR assay — and provides a visual readout, they noted.

The assay has yet to receive approval for clinical use from the US Food and Drug Administration, but in April, UCSF researchers said they were clinically validating it in an effort to fast-track the approval process through Emergency Use Authorization.

Mammoth's test will not be the first CRISPR-based SARS-CoV-2 assay on the market. Genetic engineering company Sherlock Biosciences earlier this month received FDA EUA for its Sherlock CRISPR SARS-CoV-2 kit for the detection of the virus, which provides results in approximately one hour.

However, whereas Sherlock's test is designed for use in high-volume CLIA labs and hospitals, Mammoth's test may be the first CRISPR-based SARS-CoV-2 diagnostic on the market for use in the home and the doctor's office. It will be offered to consumers in a simple, user-friendly, handheld, disposable format, delivering results in less than 20 minutes.

"We're constantly improving the chemistry, and we have improved versions of it with even faster turnaround times" than 20 minutes, Mammoth CEO Trevor Martin said. "Obviously, we're always looking to optimize sensitivity and specificity, [though] it's already extremely high and comparable to PCR, but we're definitely continuing to work on that."

In terms of the device itself, Martin likened it to a modern, digital home pregnancy test. "What makes it unique is that it would be fully disposable," he said. "So, there's no machine that you have to always have or that's super expensive. Whether it's saliva or some sort of nasal swab, you take that, you put it into the disposable, you get the answer, and then you're done."

There would likely be a phone app consumers or doctors could use to get the results, Martin added. Other than making results clearer for people to read, an added advantage of an app would be that data could also be integrated into what he called "the larger health ecosystem," becoming part of patients' electronic health records, or becoming more accessible to other medical professionals who might need those results.

Martin declined to comment on the possible price of the device, though he did say that the companies plan to make it "accessible" to consumers.

The partners also don't yet have a timeline for when the test will be available to consumers. They plan to have an EUA submission ready by the end of 2020 for review by the FDA for a version of the test that would be used in healthcare facilities. The at-home version of the test would likely require a second EUA submission, Martin said.

Importantly, he added, Mammoth has the potential to develop many more similar tests based on the DETECTR technology, such as an at-home disposable test for the flu.

"COVID19 is, obviously, what's most urgent now. But you can imagine this exact same platform being used for many different infectious diseases, and beyond," Martin said. "I think that's what's exciting — it's not just this one-trick pony. This really can usher in a new type of diagnostic that just doesn't exist, and we've suffered from its lack of existence."

The current deal Mammoth has with GSK covers SARS-CoV-2 as a primary target, he added, but the two companies have the potential to cover additional applications.

In a statement, GSK Consumer Healthcare CEO Brian McNamara said the company will be contributing its "consumer insights and commercial expertise" to help develop the test.

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