FDA approves the first SARS-CoV-2 test kit based on CRISPR tech

COVID-19 test kit

Credits: Sherlock Biosciences

Sherlock Biosciences, an Engineering Biology company, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its “Sherlock CRISPR SARS-CoV-2 test kit.” This is the first time when the FDA has allowed the use of a CRISPR-based tool, which poses both massive potential and ethical issues for patients with Coronavirus. The innovation provides the results in approximately one hour.

The new CRISPR SARS-CoV-2 test kit has the potential to be very useful in quickly identifying patients infected with Coronavirus. The kit works by programming a CRISPR molecule to detect the presence of a specific genetic signature of the virus in the sample. If this molecule finds the signature – in a nasal swab, nasopharyngeal swab, oropharyngeal swab, or bronchoalveolar lavage (BAL) specimen – for which it is trained, the CRISPR enzyme is activated and releases a detectable signal.

The standard COVID-19 testing method, known as PCR, also looks for tiny bits of the virus gene in samples collected from the patient. However, this method is slow and requires special equipment to work. The new test approved by the FDA is relatively fast and requires only basic equipment normally found in most laboratories.

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

In a press release, Sherlock Biosciences claims to work on rapidly scaling the production of its SHERLOCK test kit and will share plans for distribution and availability in the coming weeks.

In addition to this CRISPR test, the company is also studying the creation of an instrument-free, handheld test, similar to a home pregnancy test, which uses the Sherlock Biosciences’ Synthetic Biology platform to provide rapid detection of a genetic match of the SARS-CoV-2 virus.