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NEW YORK – The US Food and Drug Administration announced Thursday it has authorized marketing for PerkinElmer's GSP Neonatal Creatine Kinase-MM kit to be used in newborn screening for Duchenne Muscular Dystrophy.

The kit is the first test to aid in newborn screening for DMD, a genetic disorder that causes progressive muscle deterioration and weakness. The test was reviewed through the FDA's de novo premarket review for low-to-moderate risk devices of a new type.

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