Molecular diagnostics firm genedrive has secured approval from the NHS Health Research Authority and ethics committee to use the Antibiotic Induced Hearing (AIHL) test in hospitals trials.
This is believed to be the first ethical approval for a point-of-care genetic test relating to neonatal management in an acute setting.
The AIHL test will be trialled in the PALOH study, enrolling around 1,000 patients from two intensive care units in the UK.
The study will begin next month and will be carried out for approximately six months.
genedrive designed the MT-RNR1 screening assay for individuals with the m.1555A>G genotype. Estimates show that the genotype occurs in one out of 500 people.
In the UK, around 90,000 babies are treated with gentamicin each year for bacterial infections.
However, a baby with the m.1555A>G genotype treated with gentamicin may develop profound deafness. The AIHL test, meant for point-of-care use by nurses, is intended to help screen for this genotype.
The primary objective of the PALOH study will be to demonstrate the benefit of integrating Genedrive MT-RNR1 test platform into the existing neonatal emergency admissions process.
genedrive aims to validate the health economic benefits of the AIHL test to the NHS.
genedrive CEO 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.”
The AIHL test can be performed on the genedrive molecular platform and is said to deliver results within 30 minutes.