British molecular diagnostic company Genedrive has created an emergency care test that could save hundreds of babies a year in the UK from life-long deafness.
Around 90,000 newborn babies contract infections such as sepsis during labour each year and are routinely prescribed the aminoglycoside antibiotic, gentamicin.
However, for the approximately 1 in 500 babies with an inherited “m.1555A>G” genetic variant, a single dose of this antibiotic will result in permanent hearing loss.
In new clinical trial results, Genedrive’s test was shown to effectively detect the presence of the genetic variant in less than half an hour, compared to traditional lab-based testing, which can weeks to deliver results.
NICE guidelines state that antibiotic therapy should be started within one hour of the decision to treat with antibiotics, as any delays could put the child’s life at risk.
Prior to the availability of the Genedrive test, clinicians had no way of knowing if their newborn had the m.1555A>G variant before prescribing life-saving antibiotics, with existing genotyping technology involving time-consuming lab testing at a specialist facility.
This meant that clinicians would have to make prescribing decisions without this genetic information.
Genedrive’s test and instrument has enabled testing prior to treatment which provides clinicians with genetic information in a clinically-relevant timeframe.
The measure has the potential to spare over 14,000 newborns from permanent hearing loss around the world every year.
Dr Ron Daniels, BEM, Executive Director: UK Sepsis Trust and Vice-President: Global Sepsis Alliance said:
“The field of novel diagnostics is developing at an incredible and encouraging rate, and we support any new technology which helps clinicians to prescribe the right antibiotic in a timely fashion whilst limiting selection pressure for antimicrobial resistance.”
A 2020 study assessed if the Genedrive test could be implemented into the neonatal process to quickly and accurately identify the MT-RNRI variant in time to administer alternative treatment.
Genedrive’s antibiotic induced hearing loss test is the first time a genetic-based molecular diagnostic has been used by the NHS in an urgent care situation for newborns.
The test kit consists of a compact benchtop instrument that can be used by nurses regardless of any prior molecular testing experience.
The use of buccal swabs provides a non-invasive DNA cheek cell sample which can then be analysed for the change in the gene in just thirty minutes.
David Budd, CEO of Genedrive, said:
“There is a significant drive within the NHS to alert healthcare professionals to the impact of antibiotic-related ototoxicity and encourage them to consider genetic testing prior to initiation of treatment”.
Genedrive’s MT-RNRI test is now being rolled out to NHS hospital trusts across UK and Ireland.
