(Alliance News) - Genedrive PLC on Monday said its antibiotic induced hearing loss test has been given ethics approval by the UK National Health Service for in-hospital trials.
The Genedrive MT-RNR1 screening test targets those with a certain genotype, which is present in an estimated 1 in 500 people. When a baby with this genotype is given the antibiotic gentamicin it can result in profound deafness.
Within the UK, approximately 90,000 babies are treated with gentamicin every year to treat bacterial infections and would be candidates for the screening test.
The AIHL test was granted "full ethics approval from the NHS Health Research Authority and ethics committee". Gene drive noted this is the "first ever research ethics approval for a neonatal point of care genetic test".
The test will be used in the six-month Paloh study, which will include around 1,000 patients at "two large UK intensive care units", and is set to begin in November. It is "performed on the Genedrive molecular platform" and can take less than 30 minutes to give a result.
The main goal of the Paloh study is to assess "how well the Genedrive MT-RNR1 test platform can be implemented into the current neonatal emergency admissions process".
Genedrive will try to show the "health economic benefits of the test to the NHS" so the test will be adopted.
Genedrive Chief Executive David Budd said: "This type of test fits very well with our strengths - single use, low complexity, cost effectiveness and rapid speed to result. The opportunity to bring the power of molecular testing in a point of care acute setting will undoubtedly significantly improve the lives of patients both in this trial and in future adoption of MT-RNR1 testing."
Shares in Genedrive were untraded at 17.50 pence in London late on Monday morning.
By Anna Farley; annafarley@alliancenews.com
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