The Food and Drug Administration on Thursday authorized the first test to detect the coronavirus using CRISPR technology.
The test, manufactured by genetic engineering company Sherlock Biosciences, provides results in approximately one hour. The test kit works by programming a CRISPR molecule to detect the presence of a genetic signature specific to SARS-CoV-2 in a nasal swab, nasopharyngeal swab, oropharyngeal swab, or broncho-alveolar lavage (BAL) specimen. When the signature is found, the CRISPR enzyme releases a detectable signal. The test is designed for use in high-volume CLIA laboratories and hospitals.
Sherlock is working to rapidly scale the production of the test kit and said it will share plans for distribution and availability in the coming weeks.
"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," Sherlock Bio Cofounder, President, and CEO Rahul Dhanda said in a statement. "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 company said it is also developing an instrument-free, handheld test that would provide rapid detection of the SARS-CoV-2 virus in a format similar to an at-home pregnancy test.
This story first appeared in our sister publication, Genomeweb.