• FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy

    • December 16, 2019
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    Today, the U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness.

    “Diagnostics that can safely and effectively screen newborns can help health care professionals identify and discuss potential treatment options with parents and caregivers before symptoms or effects on a baby’s health may be noticeable,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This authorization reflects our commitment to fostering innovation in devices to help inform and provide options to patients and their caregivers. Early screening can help identify individuals who need additional follow up or treatment.”

    The GSP Neonatal Creatine Kinase-MM kit authorized today is intended to aid in screening newborns for DMD. Newborn screening is a series of tests to help health care professionals identify serious diseases and conditions shortly after birth. As part of this screening, a newborn screening card is used to collect a small amount of blood from a prick of an infant’s heel, sometimes called a heel stick. The collected, dried blood samples are used to test for a variety of diseases and conditions.


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