Molecular diagnostics company Genedrive PLC (AIM:GDR) is seeking US regulatory approval for one of its key products.
The Company has begun filing with the U.S. Food and Drug Administration for its MT-RNR1 ID Kit, the world’s first rapid point-of-care test to screen infants in an emergency care setting for a genetic variant that is lifelong Carriers of the variant are given certain antibiotics.
Those who carry the variant can then be given alternative treatments after the test has detected the variant.
The company submitted the application through the FDA’s pre-submission process because there is not yet a fully comparable test on the market.
Chief Executive David Budd said: “The US is a particularly attractive market for this unique test given the potential to save hundreds of people from lifelong deafness and reduce litigation costs associated with the undesirable side effects of antibiotic use in carriers of the gene variant Um Marketing this test in the US requires either FDA 510(k) clearance or approval of a de novo submission. Ultimately, we believe the US market may be the most attractive market given its size and birth rates is , use of diagnostic tests and reimbursement structure.”
Its shares are up 12.27% on the news at 12.25p.
8:39 am: Omega Diagnostics is strengthened by a positive study report
Omega Diagnostics Group PLC (AIM:ODX) is on the rise after a positive report from the World Health Organization.
The company sold its CD4 business to Accubio Limited in August and will receive additional payments dependent on successful trials. It is expected to receive up to an additional £4m depending on the successful outcome of a clinical trial in Kenya, which is required to maintain the test’s WHO prequalification status
Now it is said that the WHO has issued a draft performance evaluation report for the Visitect rapid CD4 test for advanced diseases. This is an important milestone to complete the prequalification and release the deferred funds to the company.
Omega now has until November 3, 2022 to review and comment on the draft report and submitted findings.
Chief Executive Jag Grewal said: “We are very pleased with this draft report detailing that the test has demonstrated high diagnostic accuracy. Although we cannot see the WHO requirements for prequalification, it is encouraging to officially receive these positive results. If the [test] successfully meets all WHO pre-qualification requirements, it will continue to be offered for sale by Accubio and the company will receive the full £4m in deferred consideration. We look forward to informing shareholders of the result in due course.”
The news sent its shares up 17.39% to 2.7p.
Elsewhere, Vertu Motors (AIM:VTU) rose 10.75% to 49.9 pence after the car dealer said full-year profits are now expected to come in above market forecasts following a strong performance in the key month of September, despite ongoing supply constraints.
Meanwhile, half-year revenue rose to £1.99 billion from £1.9 billion, although adjusted profit before tax fell to £28.2 million from £51.8 million.
It said government measures on energy costs and social security rates would benefit the group in the second half.
It added it has a strong pipeline of possible acquisitions from franchised dealerships.
