Sherlock Biosciences, Cambridge, Mass, has received FDA emergency use authorization for its Sherlock CRISPR SARS-CoV-2 kit for detection of the virus that causes covid-19. The test provides results in approximately 1 hour.
“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 clustered regularly interspaced short palindromic repeats (CRISPR) technology, which will be used to rapidly identify the virus that causes covid-19,” says Rahul Dhanda, cofounder, president, and chief executive officer of Sherlock Biosciences. “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 Sherlock CRISPR SARS-CoV-2 test kit is designed for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high-complexity tests.
Based on the company’s namesake method—specific high-sensitivity enzymatic reporter unlocking (Sherlock)—the kit works by programming a CRISPR molecule to detect the presence of a specific genetic signature—in this case, the genetic signature for SARS-CoV-2—in a nasal swab, nasopharyngeal swab, oropharyngeal swab, or bronchoalveolar lavage specimen. When the signature is found, the CRISPR enzyme is activated and releases a detectable signal.
For more information, visit Sherlock Biosciences.