By Joe Hoppe

 

Genedrive PLC said Monday that its point-of-care coronavirus identification kit has received approval, allowing it to be sold in the U.K.

The U.K.-based diagnostics company said that its Genedrive COV19-ID Kit was given coronavirus test device approval by the UK Medicines and Healthcare Products Regulatory Agency, after applying on Dec. 21.

The company said the kit is a rapid diagnostic test that delivers positive results in as little as seven-and-a-half minutes. Since the submission for approval, the product has gone through positive external validation, commercial partners have been engaged in specific countries, and product claims have been expanded to include the testing of asymptomatic patients, it said.

"The performance of the test has met CTDA standards in all regards, which positions Genedrive well to engage in opportunities as they develop going forwards in the U.K.," Chief Executive David Budd said.

 

Write to Joe Hoppe at joseph.hoppe@wsj.com

 

(END) Dow Jones Newswires

May 30, 2022 03:10 ET (07:10 GMT)

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