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The US Food and Drug Administration (FDA) has authorized the marketing of the first newborn screening test for Duchenne muscular dystrophy (DMD), the agency announced.
The GSP Neonatal Creatine Kinase-MM kit (PerkinElmer) measures levels of creatine kinase (CK) from dried blood samples collected from a draw from an infants heel 24 to 48 hours after birth. Although high levels may indicate the presence of DMD, the FDA notes that the findings would still need to be confirmed with other testing methods, such as muscle biopsies or genetic tests… (Medscape)