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(Alliance News) - Genedrive PLC on Monday said its antibiotic induced hearing loss test, the Genedrive MT-RNR1 ID kit, has obtained CE marking.
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
The molecular diagnostics company said Genedrive MT-RNR1 ID kit will be used in critical care settings to screen babies for a genetic mutation, which if present, can cause lifelong deafness when they are given certain antibiotics.
"We are very pleased to have achieved this important milestone, pioneering the availability of the first genetic acute care test for infants. CE marking of our RNR1 test allows for the next phase, with implementation evaluation by our NHS partners in Manchester and Liverpool," said Chief Executive David Budd.
Genedrive's RNR1 test is believed to be the first example of a commercial genetic screening test designed for use in an infant emergency care environment, it said. The current genetic tests that check the risk of hearing loss associated with gentamicin treatment typically take three to five days to return results, which does not meet the one hour requirement of an urgent care setting.
In comparison, the Genedrive test allows patients to be screened for the mutation upon admission in less than 30 minutes, and those that are found to have the gene mutation can be prescribed an alternative, safer treatment.
"We are planning to deploy use of the test across Manchester and Liverpool for the next six to eight months, to show how it can be successfully implemented in an NHS environment," said William Newman, clinical head of division in Genomic Medicine Manchester University NHS Foundation Trust.
Genedrive shares were trading 12% higher in London on Monday at 20.75 pence each.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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