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BioWorld - Thursday, April 23, 2026
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Home » FDA gives nod to first newborn screening test for Duchenne muscular dystrophy
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FDA gives nod to first newborn screening test for Duchenne muscular dystrophy

Dec. 13, 2019
By Meg Bryant
Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.
Medical technology Regulatory Diagnostics Neonatal/pediatrics

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