Genedrive (GDR) , the near patient molecular diagnostics company, announced on Monday that its antibiotic induced hearing loss test, the Genedrive® MT-RNR1 ID kit, had received CE marking.
The genetic screening test could prevent thousands of infants from needlessly going deaf by screening for genetic mutation in critical care settings.
Some infants are born with a mutated MT-RNR1 gene, making lifelong hearing loss a possibility if given the frontline antibiotic gentamicin.
Currently, existing genetic tests that check the risk of hearing loss associated with gentamicin treatment typically take 3-5 days to return results, failing to meet the one hour requirement of an urgent care setting.
The genedrive test allows patients to be screened for mutation in less than 30 minutes, with those found to have the mutation given an alternative, safer treatment.
The company say they believe the test is the first example of a commercial genetic screening test designed for use in an infant emergency care environment.
Chief Executive of genedrive, David Budd, described today’s news as an “important milestone” in pioneering the availability of this kind of test for infants. He commented:
“CE marking of our RNR1 test allows for the next phase, with implementation evaluation by our NHS partners in Manchester and Liverpool. At the same time, we will look to the opportunities outside of the UK where CE marking gives us market entry."
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