Genedrive to seek CE mark clearance for MT-RNR1 assay
Molecular diagnostics company Genedrive said on Tuesday that it will soon launch its MT-RNR1 assay, used for the detection of antibiotic-induced hearing loss in newborns.
Genedrive stated the MT-RNR1 assay will target the m.1555A>G mutation genotype, which if a baby carrying the mutation is given the antibiotic gentamicin, can cause lifelong deafness.
The AIM-listed firm said a large-scale implementation trial of the MT-RNR1 assay was performed on 750 newborns by Manchester and Liverpool Hospitals, representing the world's first use of a genetic point of care test in a neonatal intensive care setting and leading the firm to make improvements to the test's cartridge, instrument interface and data management options.
Genedrive will be seeking CE mark clearance for the new system in "the coming weeks" prior to commercial launch.
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 market place.
"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."
As of 1335 BST, Genedrive shares were up 3.26% at 47.50p.