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(Alliance News) - Genedrive PLC on Monday said that its Genedrive MT-RNR1 test has been accelerated by the UK's National Institute for Health & Clinical Excellence.
Genedrive is a Manchester-based molecular diagnostics company.
NICE has transferred the evaluation of the test to a new Early Value Assessment Programme. EVA is a new review process created to drive innovation by actively drawing in digital products, medical devices and diagnostics that address national unmet needs.
The EVA programme means a report will be published on the technology in a six-month timeframe instead of the initial 14 months. NICE has published a provisional schedule which says the consultation process will occur in February 2023.
The Genedrive MT-RNR1 assay is the "world's first" rapid point-of-care test to screen infants for a genetic variant that will cause life-long hearing loss when they are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection by the Genedrive test.
Chief Executive Officer David Budd said: "We are grateful to NICE for their engagement and interest in our innovative technology and pleased that the Genedrive MT-RNR1 test has been fast tracked via their new EVA programme, which may allow clinicians and patients to benefit from the test sooner. This is a testament to our technology and our ability to address this unmet need."
Shares in Genedrive were trading 2.1% at 12.00 pence each in London on Monday afternoon.
By Chris Dorrell; chrisdorrell@alliancenews.com
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