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Genedrive plc (AIM: GDR), a leader in point-of-care pharmacogenetic testing, has announced the receipt of Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Genedrive® MT-RNR1 ID Kit. This designation accelerates the pathway for the MT-RNR1 ID kit to potentially revolutionize infant healthcare by screening for a genetic variant linked to lifelong hearing loss.
Innovation in Infant Care
The Genedrive® MT-RNR1 ID Kit is the first rapid point-of-care test designed to identify infants carrying a genetic variant that can lead to permanent hearing loss when exposed to certain antibiotics. By detecting carriers early in urgent care settings, healthcare providers can promptly administer alternative antibiotics, potentially saving thousands of children from lifelong disabilities.
Healthcare Impact and Economic Benefits
The breakthrough designation underscores the kit's potential to significantly improve patient outcomes and reduce healthcare costs associated with lifelong disabilities. With an estimated 1,000 babies per year at risk in U.S. Neonatal Intensive Care Units (NICUs), the MT-RNR1 ID Kit addresses a critical need in infant care, particularly for premature infants vulnerable to aminoglycoside-induced hearing loss.
FDA Breakthrough Devices Program
Under the FDA's Breakthrough Devices Program, devices like the MT-RNR1 ID Kit undergo expedited development, assessment, and review processes. This program aims to ensure timely access to medical innovations that address life-threatening or irreversibly debilitating conditions where no approved alternatives exist.
Regulatory Pathway and Market Entry
Genedrive intends to pursue FDA De Novo classification to enter the U.S. market, leveraging the pathway to establish new standards for device performance and safety. This approach allows the MT-RNR1 ID Kit to fill a critical gap where traditional predicate devices are lacking, positioning it as a pivotal advancement in infant healthcare diagnostics.
