genedrive PLC (LON:GDR) said it had made refinements ahead of the launch of the MT-RNR1 assay that detects the mutation that can lead to antibiotic-induced hearing loss (AIHL) in newborns.
The changes have been made following “extensive feedback” from 150 nurses who were part of a trial involving 750 babies at the Manchester and Liverpool Hospitals.
The company said improvements have been made to the cartridge and instrument interface and data management options, as well as the results transmission capability.
The new Genedrive system has a seven-inch integrated touch screen, replacing the separate smartphone configuration that was used in the trial.
This avoids the issue of a misplaced phone or the complication of users trying to run multiple units from a single smartphone.
The graphical user interface menus, meanwhile, have been streamlined and larger data fields capture with parameters specific to the patients and clinical environment.
The size of the Genedrive system has also been increased to support the new screen, while the assay cartridge has also been modified with a clip mechanism to ensure an auditory ‘click’ when the cartridge is fully inserted and engaged in the instrument.
Finally, the cartridge now has a radio frequency identification electronic lock to prevent the use of expired reagents.
The group is seeking CE mark clearance for the new Genedrive system in the coming weeks and prior to the commercial launch of the assay, investors were told.
Chief executive David Budd said: “It has been very rewarding to see the positive effect of point of care AIHL testing, and the feedback and engagement of the NHS teams has been a tangible benefit to the company and will ultimately be a key driver of adoption in the marketplace.
“Following this refinement of the overall AIHL system, we are looking forward to the impending commercial launch and the improved healthcare outcomes it will offer as an innovative point of care test in a NICU care setting.
“Many children every year will be able to live profoundly different lives as a result of this successful development collaboration.”
The company said there are around 90,000 babies admitted to neonatal intensive care units each year who could benefit from the screening test.