Genedrive PLC’s MT-RNR1 ID kit has received a final recommendation from the UK's National Institute for Health and Care Excellence (NICE) meaning it can be used by the NHS.
The AIM-listed point of care molecular diagnostics company said the review was conducted through 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.
In February, shares in the firm jumped after it received preliminary approval from NICE.
The positive outcome was based on a number of key conclusions, including that the kit can 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.
These conclusions support, and are a consequence of, the company's strategy for the development of rapid molecular diagnostics for emergency care, Genedrive said in a statement.
Genedrive chief executive David Budd said: “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.”
NICE's recommendation 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.
The company expects further guidance on data collection from NICE in the coming months.