FDA Authorizes First CRIPSR Test Kit for COVID-19

The hourlong test programs a CRISPR molecule to detect specific signature for SARS-CoV-2 in a series of differing test samples.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the Sherlock CRISPR SARS-CoV-2 kit for the detection of the coronavirus 2019 (COVID-19)-causing virus.

The Sherlock Biosciences device, which provides results in approximately one hour, is the first authorized test to use CRISPR technology.

The new test kit is designed for laboratory use under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. The kit programs a CRISPR molecule to detect specific signature for SARS-CoV-2 by nasal, nasopharyngeal, or oropharyngeal swabs, or by bronchoalveolar lavage (BAL) specimen.

Once a signature is found, the CRISPR enzyme activates and releases a detectable signal for the tester. Sherlock Biosciences is currently developing a new platform that is instrument-free and handheld—similar to that of an at-home pregnancy test, according to the company.

James J. Collins, Sherlock co-founder, board member, and Termeer Professor of Medical Engineering and Science for MIT’s Institute for Medical Engineering and Science (IMES) and Department of Biological Engineering, recalled the company’s initial collaboration with Dr. Feng Zhang and colleagues to develop SHERLOCK.

The team, Collins said, believed the CRISPR-based diagnostic method in the kit would significantly impact global health.

“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,” Collins said in a statement.

David R. Walt, PhD, fellow Sherlock co-founder and board member, and co-leader of the Mass General Brigham Center for COVID Innovation, added that rapid diagnostics access is a critical and primary focus of the company during the pandemic.

“SHERLOCK enables rapid identification of a single alteration in a DNA or RNA sequence in a single molecule,” Walt said. “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.”

The company is working to rapidly scale the production of its test kit, and will share plans for distribution and availability in the coming weeks.