UK-based pharmacogenetic testing company Genedrive PLC (AIM: GDR) announced on Monday that it has received Breakthrough Device Designation from the U.S. FDA for its Genedrive MT-RNR1 ID Kit. This point-of-care test screens infants for a genetic variant that can cause lifelong hearing loss if certain antibiotics are administered. Identified carriers can be given alternative treatments, potentially saving thousands of children from hearing impairment and reducing healthcare costs.

The FDA's Breakthrough Devices Program accelerates the development and review of medical devices that provide more effective treatment or diagnosis for life-threatening conditions. Devices must meet stringent safety and effectiveness standards for marketing authorisation.

Genedrive intends to pursue the FDA De Novo regulatory pathway for U.S. market entry, allowing the establishment of new predicate devices reflecting modern performance and safety standards. The company estimates that approximately 1,000 infants annually in U.S. Neonatal Intensive Care Units are at risk of aminoglycoside-induced hearing loss, underscoring the critical need for this test.

Genedrive is focused on developing rapid, cost-effective point-of-care solutions. Its flagship products, the Genedrive MT-RNR1 ID Kit and Genedrive CYP2C19 ID Kit, enable quick genetic diagnosis to inform treatment decisions, particularly in emergency healthcare settings. The company's commercial strategy includes maximizing in-market sales, geographic expansion and strategic M&A.