The US Food and Drug Administration (FDA) has approved a COVID-19 test that uses the gene-editing tool CRISPR. The approval, which the organization announced on May 7, comes as the nation grapples with widespread test shortages.
Previous CRISPR Concerns
The CRISPR tool involves singling out specific genes in a DNA sequence. In the past, CRISPR has been at the center of some suspicion and controversy. In 2018, Chinese scientist He Jiankui made headlines by announcing that he had created two genetically edited babies using CRISPR. By singling out and disabling the gene CCR5, He claimed to be able to produce immunity to HIV in the babies.
The move seemed to underscore the scientific community’s misgivings about CRISPR. At the time, National Institute of Health (NIH) Director Francis Collins said that He’s work “represents a deeply disturbing willingness by Dr. He and his team to flout international ethical norms.”
CRISPR vs. COVID
However, some scientists and researchers working to develop tests for the COVID-19 pandemic have come to embrace the technology. Parentology previously reported that the University of California, San Francisco (UCSF) and Mammoth Biosciences had collaborated on a CRISPR-based coronavirus test. The test was reportedly six times faster than tests administered by the Centers for Disease Control and Prevention (CDC).
The CRISPR test that’s getting FDA approval was developed by Sherlock Biosciences. The engineering biology company has received an Emergency Use Authorization (EUA) from the FDA for use on patients.
“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,” said Rahul Dhanda, president and CEO of Sherlock, in a statement.
Meanwhile, the FDA said in an official correspondence with Sherlock that the test will be limited to use in authorized laboratories and that the EUA will be in effect for the duration of the coronavirus emergency.
FDA CRISPR — Sources:
Stat – “Are scientists’ reactions to ‘CRISPR babies’ about ethics or self-governance?”
Stat – “Claim of CRISPR’d baby girls stuns genome editing summit”
US Food and Drug Administration