FDA OKs emergency approval for coronavirus test kit created by Massachusetts-based company

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The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for a rapid diagnostic, gene-editing tool in detecting the coronavirus.

The Cambridge, Mass.-based engineering biology company, Sherlock Biosciences, developed a “CRISPR SARS-CoV-2 kit” to detect the virus in about one hour.

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Sherlock Biosciences' co-founders include, from left, David Walt, Todd Golub, Rahul Dhanda, Feng Zhang and Deborah Hung. 

Sherlock Biosciences' co-founders include, from left, David Walt, Todd Golub, Rahul Dhanda, Feng Zhang and Deborah Hung.  (Sherlock Biosciences)

“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, co-founder, president and CEO of Sherlock Biosciences, in a company statement. “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.”

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The diagnostic, gene-editing tool first works to detect the virus through a nasal or oropharyngeal swab or fluid sampling from airways in the lungs. A CRISPR molecule is programmed to detect the genetic signature for SARS-CoV-2.

If the signature is found, the CRISPR enzyme activates and releases a detectable signal, the company said.

During public health emergencies, the FDA can use an EUA to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat or prevent serious or life-threatening diseases upon meeting certain criteria, the federal agency says.

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The FDA released a EUA late last month, for example, for a self-collected at-home coronavirus diagnostic test using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit.

"Throughout this pandemic, we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," Dr. Stephen Hahn, FDA Commissioner, previously said.

Fox News's James Rogers contributed to this report.