genedrive PLC (AIM:GDR) shares jumped 32% after it received Breakthrough Device Designation from the US Food & Drug Administration for its Genedrive MT-RNR1 ID kit.
This diagnostic is the first rapid point-of-care test to screen infants for a genetic variant that can cause lifelong hearing loss if certain antibiotics are administered.
Identifying carriers of the variant allows for the use of alternative antibiotics, potentially saving thousands of children from hearing loss and benefiting healthcare systems financially. Genedrive plans to pursue the FDA De Novo regulatory pathway to enter the U.S. market.
In early trading, the stock was up 0.9p at 3.7p.