Genedrive’s Rapid Test Wins FDA Breakthrough Status

Genedrive (GB:GDR) has released an update.

Genedrive PLC has received the coveted FDA Breakthrough Device Designation for its Genedrive MT-RNR1 ID Kit, the first rapid point-of-care test to help prevent aminoglycoside-induced hearing loss in infants. This pioneering test, which identifies genetic variants linked to hearing loss, aims to improve patient outcomes and reduce healthcare costs by avoiding expensive malpractice litigation. The designation expedites the device’s development and review, potentially speeding up its entry into the lucrative U.S. market.

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