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(Alliance News) - Genedrive PLC on Thursday said the UK National Institute for Health & Care Excellence ratified and finalised its recommendation that Genedrive's hearing loss gene screening test MT-RNR1 ID kit can be used by the NHS.
Shares in Genedrive were down 8.0% to 33.81 pence each in London on Thursday late morning.
The MT-RNR1 ID kit test is used to screen infants for a genetic variant which causes lifelong hearing loss if those who carry it are dosed with certain antibiotics.
The Manchester, England-based point-of-care molecular diagnostics company said the review was conducted via NICE's early value assessment programme, which was designed to select and recommend new technologies that "will make a real difference to patients and provide the most value for the NHS".
It said the positive outcome was based on a number of conclusions, including the kit being able to "quickly and accurately identify babies with the MT-RNR1 genetic variant who may be at risk of hearing loss if given aminoglycoside antibiotics", and that "no other test is available to provide results quickly enough to inform decisions on antibiotic prescribing in emergency care".
Genedrive said these conclusions support and are a consequence of its strategy for the development of rapid molecular diagnostics for emergency care.
It added the NICE recommendation will support 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, while further guidance on data collection from NICE is expected in the coming months, Genedrive said.
"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," said Genedrive Chief Executive Officer David Budd.
"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."
On Monday last week, Genedrive said its MT-RNR1 ID Kit was set to roll out at two more hospitals in the UK's North West National Health Service.
Genedrive said it is working with Manchester Academic Health Science Centre Women & Children Domain, which falls under Health Innovation Manchester. It continues to work with HInM for the rollout across a further five neonatal sites in Greater Manchester.
"Once fully subscribed at this regional level, the test would be available when needed to circa 30,000 newborns over the next NHS fiscal year, of which 10-12% are modelled to be admitted to a regional neonatal unit," Genedrive said at the time.
The roll-out is part of the firm's implementation project, which will begin from April, following NICE's final recommendation.
By Greg Rosenvinge, Alliance News reporter
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