Sherlock Biosciences has announced that the US FDA has granted them Emergency Use Authorization (EUA) for its Sherlock™ CRISPR SARS-CoV-2 kit for the detection of the virus that causes COVID-19, that can provide results in approximately one hour.

The Sherlock™ CRISPR SARS-CoV-2 test kit is designed for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

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 this case, the genetic signature for SARS-CoV-2 – 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 Sherlock CRISPR SARS-CoV-2 kit has been designed to detect fragments of the Open Reading Frame (ORF1ab, “O”) gene and the Nucleocapsid (“N”) gene of SARS-CoV-2.

An included third target is the human RNase P POP7 gene (“RP”) which serves as a control for the extraction of the clinical sample in the absence of a positive SARS-CoV-2 result.

A dedicated instrument platform (e.g., thermal cycler) is not required. Amplification can be performed using a heat block, and CRISPR complex activation and reporter cleavage can be run in a standard microplate reader capable of fluorescence detection.

The entire reaction from RT-LAMP amplification to CRISPR-based detection of the target analytes can be performed in approximately one hour.

In addition to SHERLOCK, the company is also developing its INSPECTR™ platform to create an instrument-free, handheld test – similar to that of an at-home pregnancy test – that utilizes Sherlock Biosciences’ Synthetic Biology platform to provide rapid detection of a genetic match of the SARS-CoV-2 virus.

Also, earlier this year, Cepheid and Sherlock Biosciences announced a research collaboration between the two companies to explore the development of new cutting-edge molecular diagnostic tests to run the SHERLOCK CRISPR-based tests on the Cepheid's GeneXpert® Systems.