First CRISPR test for the coronavirus approved in the United States
A nurse practitioner takes swab samples from a person in Los Angeles, California
More than 60 coronavirus tests have been approved for emergency use in an effort to keep pace with the pandemic.Credit: Al Seib/Los Angeles Times via Getty
The US drug regulator has granted its first emergency-use approval for a new coronavirus test that takes advantage of the gene-editing technology CRISPR.
The US Food and Drug Administration’s (FDA) emergency-use authority allows it to make tests and drugs available faster than usual in a public-health emergency. The new diagnostic kit is based on an approach co-developed by CRISPR pioneer Feng Zhang at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts. It will be used to test for the novel coronavirus behind the ongoing pandemic, SARS-CoV-2, in laboratories that are certified to provide clinical-test results.
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Although the United States has ramped up testing in the past week — averaging nearly 250,000 tests per day, according to the non-profit organization The COVID Tracking Project — there are test shortages in some places. Widespread use of the new FDA-approved kit could help to alleviate backlogs and increase testing, says Mitchell O’Connell, a biochemist at the University of Rochester in New York, who was not involved in developing the test. But O’Connell cautions that it remains to be seen how well the test performs in real-world conditions, such as hospitals, compared