US drug regulating agency approves first CRISPR tests for coronavirus detection

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the first CRISPR-based diagnostic test kit to detect coronavirus in the country. This is the first time that a CRISPR test, which is based on gene-editing technology, has received FDA approval for use on patients. The new Sherlock™ CRISPR SARS-CoV-2 kit has been co-developed by CRISPR pioneer Feng Zhang at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts, and Sherlock Biosciences, an engineering biology company based in Cambridge, Massachusetts.

The CRISPR technology offers a fast and efficient way to find and link on to any genetic sequence in a specimen. In the new kit developed specifically for identifying COVID-19 cases, a CRISPR molecule has been programmed to search for the presence of the virus gene in a patient sample. Once it finds a virus gene, the CRISPR enzyme emits a fluorescent glow.

The US, which currently has the highest incidence of COVID-19 cases, has been conducting around 250,000 test per day on an average (according to not-for-profit The COVID Tracking Project). However, some believe that the scale of tests need to be increased exponentially for the country to be able to control the pandemic. Currently, the standard method being used for COVID-19 testing is slow and requires specialized equipment. Simple tests that provide results fast are the only way to scale up testing. The new CRISPR SARS-CoV-2 testing kit, which provides results in an hour, is expected to ease out this bottleneck.

“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,” says Rahul Dhanda, co-founder and CEO of Sherlock Biosciences. Currently, the test can be performed on patients only in certified clinical-test laboratories, but the company said in a press release that it is working to design a single-cartridge kit using the same technique that would not require the sample to be sent to a laboratory, but can be performed at home, in the manner of pregnancy test kits. However, none of the >60 diagnostic tests for SARS-COVID-2 that have received EUAs from the FDA to allow them to administer these tests and process the results in more local settings.   

References:

• First CRISPR test for the coronavirus approved in the United States
• FDA approves first CRISPR test for coronavirus detection
• FDA authorizes CRISPR-based test for COVID-19

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*Photo by Sharon McCutcheon on Unsplash