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(Sharecast News) - Molecular diagnostics company Genedrive has notified the United States Food and Drug Association (FDA) of its intention to import and distribute its 'Genedrive 96 SARS-CoV-2 Kit' prior to an emergency use authorisation (EUA) determination, it announced on Wednesday.
The AIM-traded firm said notification was made on 25 November and acknowledged on 15 December.
It said the current claims of the product covered high-throughput testing on a variety of third-party RT-PCR platforms for upper respiratory tract specimens.
"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," said chief executive officer David Budd.
"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.
"We are confident in the performance claims of our assay and have generated independent evaluation data in the United States at non-automated sites and our automated Biomek installations which confirm our product claims."
Genedrive said that in light of the increasing numbers of Covid-19 cases throughout the US and the need to expand capacity for testing during the public health emergency, the FDA had stated that it did not object to a commercial manufacturer's development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time, where the test had been validated and while the manufacturer had made an emergency use authorisation request, where the manufacturer gave the appropriate notification of validation to FDA, and where the manufacturer provided instructions for use of the test and posted data about the test's performance characteristics on its website.
The product would bear a label stating that 'validation of this test had not been reviewed by FDA - review under the EUA program is pending'.
At 1215 GMT, shares in Genedrive were up 18.57% at 50.75p.
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