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FDA Oks COVID Test Using Gene-Editing Technology

dna molecules illustration

May 8, 2020 - The FDA has granted emergency use authorization for a coronavirus-detection test that uses CRISPR gene-editing technology.

Emergency authorization means the test fills an unmet need in the market but does not mean the FDA has reviewed the test or approved its use.

Sherlock BioSciences Inc. of Cambridge, Massachusetts, the company marketing the CRISPR SARS-CoV-2 Kit, says it will provide results in about an hour. CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats.

The Sherlock webpage says the kit works by programming a CRISPR molecule to detect the genetic signature of COVID-19 in a nasal swab or specimen drawn from a person.

When the genetic signature is found, the CRISPR enzyme is activated and releases a signal to show that the person is infected with the coronavirus, Sherlock said.

Sherlock says this is the first FDA-approved use of CRISPR technology.

“We think this has a lot of potential. The test doesn’t require any complicated or expensive equipment,” said Feng Zhang, a leader of the research team and a co-inventor of CRISPR, according to The Washington Post.

The emergency authorization allows the test to be used in laboratories, but Zeng said it could eventually be used by nonprofessionals for rapid diagnosis, as in a workplace setting to screen employees.

The Post said the test was developed by researchers at the Massachusetts Institute of Technology, Harvard University, the Ragon Institute, and the Howard Hughes Medical Institute.

WebMD Health News Brief Reviewed by Michael W. Smith, MD on May 11, 2020

Sources

FDA.gov, “Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020.”

Sherlock Biosciences Inc., “Sherlock Biosciences Received FDA Emergency Use Authorization for CRISPR SARS-COV-2 Rapid Diagnostic.”

The Washington Post, “FDA Gives Emergency Authorization for CRISPR-Based Diagnostic Tool for Coronavirus.”

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