Genedrive hearing loss test issued MIB from NICE

Genedrive shares gained 10% to 27.5p on Tuesday after the UK’s National Institute of Clinical Excellence (NICE) issued a new Medtech Innovation Briefing (MIB) on the Genedrive hearing loss test, MT-RNR1.

The near-patient molecular diagnostics company’s price rose despite Gendrive’s reported poor performance in their half-year results earlier today.

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Genedrive recently launched its new Genedrive System for Antibiotic Induced Hearing Loss (AIHL). The test will identify the cause of life-long hearing loss through screening for genetic mutation.

The trial for AIHL was CE marked in December 2019 and completed performance trials at Manchester University NHS Trusts in June 2021.

The company deployed the Genedrive MT-RNR1 test in the UK and Ireland earlier this month to Manchester University Hospital Trust for routine use.

Genedrive reported no revenues in H2 2021 compared to £0.4m in 2020 due to delays in product development.

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Genedrive saw an operating loss of £2.8m compared to £2.9m in 2020 with effective management of costs leading to a decline in R&D costs from £2.3m to £1.9m. The loss prevailed from the previous year due to the stockpiling of Genedrive96 SARS-COV-2 Kits.

The company incurred a cost of £14k due to interest charged for leasing the business’ principal premises.

The company noted a pre-tax loss of £2.8m in 2021 compared to £671k profits in 2020.

Genedrive is now debt-free and has a cash balance of £6.3m in 2021 compared to £3.8m in 2020, benefitting from £1.2m of R&D tax credit.

The company’s loss per share was 3.3p in 2021 compared to earnings per share of 1.9p in 2020.

David Budd, CEO, Genedrive, said, “We have achieved some key milestones in this period, namely the CE marking of our Genedrive POC COVID-19 test, which was closely followed by a number of distribution agreements with key territories.”

“We have also made significant further progress with our AIHL system, establishing initial installations and generating significant evidence and support to make commercial progress.”

Budd believes the company is “well positioned to deliver on shareholder value” as the company has carefully managed its cash position to continue expanding its portfolio.

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