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UK's NICE to Accelerate Assessment of Genedrive Test

NEW YORK – The UK's National Institute for Health and Clinical Excellence has created a new program to evaluate innovative technologies and plans to assess Genedrive's MT-RNR1 test for antibiotics-induced hearing loss in infants via this new process, the company said on Monday.

NICE is part of the UK Department of Health and Social Care and publishes guidance for healthcare professionals. It has been assessing Manchester, UK-based Genedrive's test through its Diagnostic Assessment Program, which can take about 63 weeks to produce a report.

According to Genedrive, NICE has now established an Early Value Assessment program, the purpose of which is to "drive innovation into the hands of healthcare professionals" and which will have a six-month-long process, as opposed to the 14-month DAP timeline. According to Genedrive, a provisional consultation on its test will now take place in February 2023.

Genedrive CEO David Budd said in a statement that the EVA program might "allow clinicians and patients to benefit from the [MT-RNR1] test sooner."

Genedrive's test relies on a reverse-transcription loop mediated isothermal amplification approach to screen patients for MT-RNR1 m.1555A>G, a variant that predisposes carriers to hearing loss when prescribed gentamicin, a first-line antibiotic given to newborns admitted to intensive care units. The assay runs on the company's portable Genedrive System. Genedrive gained a CE-IVD mark for the test in 2019.

NICE is separately assessing Genedrive's CYP2C19 ID Kit through its DAP. The assay is one of several CYP2C19 genotyping approaches being assessed for how well they can determine how a patient suffering from ischemic stroke or a transient ischemic attack might respond to clopidogrel, an antiplatelet therapy.