CRISPR Coronavirus test gets approval | Daily News


 

CRISPR Coronavirus test gets approval

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 on 6 May.

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 developed by CRISPR pioneer Feng Zhang at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts. It will be used to test for SARS-CoV-2 in laboratories that are certified to provide clinical-test results.

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 with standard tests.

The CRISPR-based diagnostic kit has been developed by Sherlock Biosciences, a biotechnology company also based in Cambridge. It works by programming the CRISPR machinery to detect a snippet of SARS-CoV-2 genetic material in a nose, mouth or throat swab, or in fluid from the lungs. If the virus’s genetic material is found, a CRISPR enzyme generates a fluorescent glow. The test can return results in about an hour, according to the company.

Researchers led by Zhang first described the basis of the test approach in 20171, and showed that it could detect low levels of Zika and Dengue virus. (Nature)


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