Sherlock’s CRISPR SARS-CoV-2 Rapid Diagnostic Gets FDA Emergency Use Approval

Sherlock’s CRISPR SARS-CoV-2 Rapid Diagnostic Gets FDA Emergency Use Approval
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CRISPR engineering biology company Sherlock Biosciences today announced today that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Sherlock CRISPR SARS-CoV-2 test kit for the detection of the virus that causes COVID-19.

“While it has only been a little over a year since the launch of Sherlock Biosciences, today we have made history with the very first FDA-authorized use of CRISPR technology, which will be used to rapidly identify the virus that causes COVID-19,” said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences in a press release. “We are committed to providing this initial wave of testing kits to physicians, laboratory experts and researchers worldwide to enable them to assist frontline workers leading the charge against this pandemic.”

The kit, which provides results in roughly one hour, is the first FDA EUA for the use of CRISPR technology in a diagnostic. While the test kits are not currently available, the company said it is scaling up production and will announce its plans for distribution of the kits in the coming weeks.

The diagnostic has been designed to be used in CLIA certified laboratories and is based on the technology—Specific High-sensitivity Enzymatic Reporter unlocking (SHERLOCK)—that gives the company its name. The test works via the programming of a CRISPR molecule designed to detect the genetic signature of the SARS-CoV-2 virus, using specimens obtained via a nasal swab, nasopharyngeal swab, oropharyngeal swab or bronchoalveolar lavage. If the signature is found, the CRISPR enzyme is activated and releases a detectable signal.

“When our lab collaborated with Dr. Feng Zhang’s team to develop SHERLOCK, we believed that this CRISPR-based diagnostic method would have a significant impact on global health,” said James J. Collins, co-founder and board member of Sherlock. “Development of the SARS-CoV-2 test kits has shown that SHERLOCK technology is not only faster than what we’re seeing with real-time PCR test kits; it is more precise, providing true positive and true negatives with 100 percent accuracy in patient samples. During what is a major healthcare crisis across the globe, we are heartened that the first FDA-authorized use of CRISPR will aid in the fight against this global COVID-19 pandemic.”

Access to rapid diagnostics is critical for combating this pandemic and is a primary focus for Sherlock Biosciences co-founder and board member, David R. Walt, Ph.D., who co-leads the Mass General Brigham Center for COVID Innovation.

“SHERLOCK enables rapid identification of a single alteration in a DNA or RNA sequence in a single molecule,” said Dr. Walt. “That precision, coupled with its capability to be deployed to multiplex over 100 targets or as a simple point-of-care system, will make it a critical addition to the arsenal of rapid diagnostics already being used to detect COVID-19.”