genedrive PLC (AIM:GDR), a British molecular diagnostics company, saw its shares plunge on Wednesday after its full-year loss widened.
The company reported an annual loss of £5.2 million in the fiscal year ending 30 June 2023, slightly higher than the previous year’s loss of £4.7 million, though yearly spending on research and development stayed at £3.9 million.
It reported hitting several new milestones in pharmacogenetic testing, an area in which it offers personalised medicine based on the patient’s genetic profile, rolling out testing kits in the UK to prevent hearing loss in newborns, and taking steps to enter the American market.
The company’s Genedrive MT-RNR1 ID Test, which detects a genetic mutation that predisposes newborns to antibiotic-induced hearing loss (AIHL), received a positive final recommendation from NICE’s Early Value Assessment programme.
A rollout of the testing kit is underway in Greater Manchester hospitals, and the pharmaceuticals company has secured further commercial distribution agreements in several countries in Europe as well as Saudi Arabia, Kuwait and Turkey.
Genedrive said it is also in the pre-submission process with the US Food and Drug Administration (FDA) to enter the American market for AIHL testing.
The company said it has achieved UK Conformity Assessment (UKCA) marking for its new Genedrive CYP2C19 pharmacogenetic test, which determines how stroke patients metabolise the antiplatelet drug clopidogrel, designed to prevent fatal clots.
The test is expected to benefit from a £1.2 million multi-partner grant for validation in time-critical NHS settings.
Draft guidance by the UK’s National Institute for Health and Care Excellence (NICE) has recommended CYP2C19 genotyping for clopidogrel treatment as a clinically and cost-effective option. “This year has been both challenging and rewarding, the road to commercialisation of groundbreaking innovative products is long and challenging, due to the collection of data required and the sheer size of the NHS and funding complexities of Integrated Care Systems,” said chairman Ian Gilham.
Genedrive’s cash position nearly halved to £2.6 million at the end of the year, compared to £4.6 million in 2022.
Its share price had fallen by 14.89% to 6.49 pence per share by 11.30 am on Wednesday morning, after hitting a nadir of about 5.04p.