Mammoth Biosciences has announced a collaboration with GSK Consumer Healthcare to develop an accurate, easy-to-use, fully disposable, rapid and handheld test that consumers and healthcare providers in clinics can use to detect active SARS-CoV-2, the novel coronavirus that causes COVID-19. The collaboration will use Mammoth Biosciences’ CRISPR-based DETECTR™ platform that can identify and signal the presence of viral RNA strands obtained through a simple nasal swab.
The new test will have the quality and reliability of the proprietary and patented DETECTR platform, which has peer-reviewed validation demonstrating the system’s potential to deliver diagnostic results for SARS-CoV-2 in a simple, consumer-friendly handheld format, while retaining gold standard sensitivity and specificity. The test, which has the potential to deliver point-of-use results in less than 20 minutes, will not require a complex laboratory setting with large equipment and time-consuming multi-step processes. It will be a disposable and easily distributable diagnostic which, subject to regulatory review, will be available first in the clinical setting and ultimately by consumers at home.
Beyond COVID-19, the platform has potential diagnostic applications spanning a variety of infectious diseases. Currently under EUA review, DETECTR recently received peer-reviewed validation demonstrating its diagnostic power, published in Nature Biotechnology.
“Our mission at Mammoth has always been to redefine the relationship that consumers have with their health, and through our collaboration with GSK Consumer Healthcare, we’ll be able to do just that,” offered Trevor Martin, CEO and cofounder of Mammoth Biosciences. “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.”
Brian McNamara, CEO of GSK Consumer Healthcare, said: “We are committed to helping our consumers stay healthy during this pandemic and believe access to quality and accurate testing is a critical need. We are excited to be working with Mammoth Biosciences and contributing our consumer insights and commercial expertise to develop a disposable rapid test that consumers can use to detect active COVID-19. We look forward to bringing the power of testing out of the lab and into people’s homes.”
Mammoth and GSK Consumer Healthcare have begun work on the COVID-19 test and are aiming to have a device submitted for FDA Emergency Use Authorization (EUA) review before the end of 2020. The test will then be made available to US healthcare facilities that diagnose or treat COVID-19, and are eligible to use EUA-approved tests, with the goal of having it subsequently available over-the-counter to consumers. Following the development of a COVID test, both companies intend to explore how they can use the DETECTR™ technology platform to develop other types of diagnostics for consumer use.
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