Genedrive COVID kit receives CE-IVD certification By Investing.com

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Genedrive COVID kit receives CE-IVD certification

Published Dec 08, 2021 12:43

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Genedrive COVID kit receives CE-IVD certification

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By Samuel Indyk

Investing.com – Shares in genedrive (LON:GDRG) shot higher before paring gains on Wednesday after the company announced that its rapid point of care Genedrive COV19-ID Kit had received CE-IVD certification under the European Communities Council Directive 98/79.

The kit is a diagnostic kit that can deliver positive results in under eight minutes and negative results in 17 minutes.

“This is an important milestone in the development of our new rapid molecular COVID19-ID test and we can now move forward with our commercial plans,” said genedrive CEO David Budd. “We have developed a very fast and easy to use Point of Care system that will allow immediacy and convenience in molecular testing, rather than waiting many hours or days for results from a central laboratory.”

The company reiterated that the product is being provided for review and evaluation to a range of potential commercial partners who have actively expressed interest in the product with regard to European opportunities.

Detection of Omicron

In the case of the new Omicron Variant of Concern, genedrive said there were approximately 650 Omicron genome sequences identified within the global reference database as of 7^th December and the company’s kit was 100% inclusive in detection.

“The newest Variant of Concern highlights that COVID is an ongoing and long-term global health issue and our ability to manage it better can be aided by rapid detection to prevent ongoing transmissions, using innovative products like the new Genedrive COV19-ID kit,” Budd added.

At 12:50GMT shares in genedrive were trading higher by 2.0% at 48.00 pence per share.

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