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PerkinElmer's Muscular Dystrophy Screening Kit Receives FDA Marketing Authorization

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.

The test measures the concentration of the CK-MM protein, which enters the blood stream in increased amounts when there is muscle damage, from dried blood samples collected from a newborn's heel 24 to 48 hours after birth. Elevated levels may indicate the presence of DMD, but the kit isn't intended for DMD diagnosis or for screening of other forms of muscular dystrophies.

FDA authorization allows labs to add the test to their newborn screening panel, a series of tests to help clinicians identify serious diseases shortly after birth. Though the US Department of Health and Human Services has a list of core and secondary conditions for screening newborns, called the Recommended Uniform Screening Panel, PerkinElmer's FDA authorization isn't a recommendation for DMD to be added to the uniform screening panel.