The U.S. Food and Drug Administration (FDA) granted Sherlock Biosciences an emergency use authorization (EUA) for its Sherlock CRISPR SARS-CoV-2 kit, according to the agency’s website.
Founded nearly 14 months ago, Sherlock Biosciences said its assay is the first FDA-authorized use of CRISPR technology to detect SARS-CoV-2, the virus that causes COVID-19.
The Sherlock CRISPR SARS-CoV-2 test kit, which delivers results in about one hour, is designed for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, the company said in a news release.
Based on the SHERLOCK method, which stands for Specific High-sensitivity Enzymatic Reporter unLOCKing, the kit works by programming a CRISPR molecule to detect the presence of a specific genetic signature in a nasal swab, nasopharyngeal swab, oropharyngeal swab or bronchoalveolar lavage (BAL) specimen. When the signature is found, the CRISPR enzyme is activated and releases a detectable signal, the company said.
Sherlock Biosciences, based in Cambridge, MA, also said it is developing a platform to create an instrument-free, handheld test to provide rapid detection of a genetic match of the SARS-CoV-2 virus.
