Genedrive – company wins NICE approval for its MT-RNR1 ID diagnostic kit for use in the NHS
The point of care molecular diagnostics company Genedrive (LON:GDR) has announced that the UK's National Institute for Health and Care Excellence (NICE) has given positive final guidance for its MT-RNR1 ID Test kit to be used by the NHS.
The NICE Early Value Assessment programme selects and recommends new technologies that will make a real difference to patients and provide the most value for the NHS.
The MT-RNR1 ID Kit rapidly and accurately identifies babies with the MT-RNR1 genetic variant who may be at risk of hearing loss if given aminoglycoside antibiotics.
It is stated that no other test is available to provide results quickly enough to inform decisions on antibiotic prescribing in emergency care.
Genedive has been developing and commercialising a point of need molecular diagnostic platform that is low cost, rapid, versatile, easy to use and robust.
It is needed for the diagnosis of infectious diseases and for the use in genotyping which is the patient stratification process, for detection of pathogen and other indications.
The AIM-quoted group has assays on the market for the detection of MT-RNR1, HCV, certain military biological targets, a high throughput SARS-CoV-2 assay and a point-of-care test for Covid-19.
It is also currently developing a genetic test for CYP2C19 metaboliser status.
NICE's recommendation on using the Genedrive® MT-RNR1 test in NHS England and Wales through its EVA program will support additional data generation requirements whilst the test is being used routinely within NHS sites. It is anticipated that this data collection process will be several years in duration.
CEO David Budd stated that:
"We are appreciative of the thorough review conducted by the NICE team. The final report issued today entirely reflects the preliminary conclusion published in February.
As we continue with commercial roll out and product adoption, the NICE EVA framework will give us the opportunity to support specific performance and impact data that NHS users and commissioners may look for in future guidance.
NICE, whose guidance is formally applicable to the NHS in England and Wales, is an internationally respected health authority and the tools and data supplied in its review will be relevant to the rest of the United Kingdom and to the other international markets which we are now accessing."
Prior to today’s news the £34m capitalised group’s shares closed 8% lower last night at 36.75p.