announced on Tuesday that its Antibiotic Induced Hearing Loss assay kit (Genedrive® MT-RNR1) demonstrated high clinical accuracy in a case-control clinical validation.
Genedrive’s kit targets the m.1555A>G mutation genotype, which if carried by a baby that is given gentamicin, a common treatment for bacterial infections, it can cause lifelong deafness.
About 90,000 babies in the UK are treated with gentamicin each year who could potentially benefit from genedrive’s screening test, which can detect the mutation down to levels of 10% in cells.
David Budd, Chief Executive Officer of genedrive plc, said: "We are extremely pleased with the performance of the test and very excited about the impact the test could have in emergency settings.”
Shares were trading 9.3% higher at 23.5p during Tuesday morning trading
The Genedrive kit achieved a diagnostic sensitivity of 100% and a specificity of 100% on a cohort of 303 samples, unaffected by common bacteria and interfering substances usually expected in patients.
Mr. Budd said: “The next step will be to undertake our implementation study in Manchester and Liverpool hospitals, where the goal is not only to replicate the analytical performance outcomes, but also to ensure the test can be implemented in an NHS environment.”
“By doing so we aim to maximise uptake at admission and ensure test results can be obtained quickly and acted upon in the relevant clinical time window.”
The test uses a single-use disposable cartridge, delivering a genetic result in 30 minutes, which allows for treatments to be altered within the one hour treatment window under NICE treatment guidelines.
The test is CE marked, which Mr. Budd said will allow Genedrive to start establishing commercial opportunities across targeted areas of the EU.
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