16th Dec 2020 11:04
Genedrive PLC - Manchester-based molecular diagnostics firm - Notifies US Food & Drug Administration of intention to import and distribute its Genedrive 96 SARS-CoV-2 Kit, prior to an Emergency Use Authorization determination.
FDA states that it does not object to a commercial manufacturer's development and distribution of SARS-CoV-2 test Kits for a period of time, where the test has been validated and while the manufacturer has made an Emergency Use Authorization request.
"Genedrive submitted its application to the FDA in May of this year but owing to the volume of applications received we are still waiting for EUA review. However, in order to support the Beckman Biomek system's transition into clinical use and exploit commercial opportunities, the product needs to be commercially available in the United States to end users," said Chief Executive Officer David Budd.
Current stock price: 52.50 pence, up 23% on Wednesday
Year-to-date change: more than 100% from 22.50p
By Dayo Laniyan; [email protected]
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