COVID-19Regulatory

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

May 8, 2020 / By Kayla Rivas | Fox News

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.

“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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Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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