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GSK, Biotech Partner on Crispr Covid-19 Test

Crispr genome edits illustration

(NIH.gov)

21 May 2020. A biotechnology company using gene editing for diagnostics is developing a fast, point-of-care Covid-19 test with drug maker GlaxoSmithKline. Financial and intellectual property details of the agreement between Mammoth Biosciences in South San Francisco, California and GSK’s consumer health care division in London were not disclosed.

Mammoth Biosciences applies the gene editing technology Crispr to medical diagnostics, treatments, and drug discovery. Crispr, short for clustered regularly interspaced short palindromic repeats, is a technique for editing genomes based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. The company is a spin-off enterprise from the lab of Crispr pioneer Jennifer Doudna at University of California in Berkeley, with Doudna as a co-founder.

As reported in Science & Enterprise in January, recent research in Doudna’s lab identified precise and efficient editing enzymes that Mammoth Biosciences licenses from UC-Berkeley for its diagnostics work. Those enzymes also emit signals when they make genome edits, with this property built into the company’s Detectr technology. Detectr searches for specific gene sequences in a specimen sample, and if found at the target gene location, the enzyme cuts the DNA and reads signals from the edited strand to confirm the genetic sequence as a biomarker.

When applied to Covid-19, Detectr inspects self-administered nasal swabs from the front of the nose, not nasopharyngeal swabs that require trained clinicians in full protective gear to collect specimens of secretions at the back of the throat. In a paper published last month in the journal Nature Biotechnology, researchers from Mammoth Biosciences and academic labs show a Detectr test for SARS-CoV-2 viruses can return results in about 40 minutes that agree 95 percent of the time with gold-standard reverse transcription – polymerase chain reaction, or RT-PCR, tests for positive readings, and 100 percent with negative results. The test is also self-contained, using disposable test strips that change color to indicate a positive reading.

Mammoth says it refined its Covid-19 test to now return results in 20 minutes. GSK and Mammoth envision their Covid-19 test will be used first by clinicians, and later packaged for home use and even sold over-the-counter. The companies say the test will be submitted for an emergency authorization by Food and Drug Administration by the end of 2020. The test’s earlier version described in the Nature Biotechnology paper is already under FDA review.

In a company statement released through WebWire, Trevor Martin, CEO and cofounder of Mammoth Biosciences, says its Detectr technology can be applied to a range of infectious diseases. “Covid-19 is, of course, a key focus right now, but as a society what we need is a foundational shift in diagnostics: a scalable means to widely address disease detection. With a Crispr-based diagnostic we can achieve a rapid and true point-of-need test without compromising the accuracy of molecular testing for all types of infectious diseases.”

Mammoth and GSK are competing with a similar fast, disposable, point-of-care Covid-19 test developed by Sherlock Biosciences in Cambridge, Massachusetts. That test uses Crispr to edit RNA rather than DNA, and received an emergency authorization from FDA earlier this month.

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