The Food and Drug Administration (FDA) has approved the GSP Neonatal Creatine Kinase-MM kit for use in screening newborns for Duchenne Muscular Dystrophy (DMD).

This approval allows laboratories to add the test to the newborn screening panel should there be a specific need for screening. The test is not intended for use in diagnosing DMD or screening for other forms of muscular dystrophies. 

The GSP Neonatal Creatine Kinase-MM kit test works by measuring the levels of creatine kinase-MM from dried blood samples collected through a heel stick 24 to 48 hours after birth. An elevated level of creatine kinase-MM may indicate the presence of DMD, although results should be confirmed using other testing methods (ie, muscle biopsies, genetic and other lab tests).

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A clinical study (N=3041) evaluating the GSP Neonatal Creatine Kinase-MM kit showed that the test was able to accurately identify 4 screened newborns with DMD-causing genetic mutations. Additional testing on samples from newborns with confirmed DMD (N=30) showed that the test correctly identified all of the samples. Moreover, to assess the risk of false negatives, the device manufacturer, PerkinElmer, performed genetic testing on a subset of patients identified as negative by the GSP Neonatal Creatine Kinase-MM kit; results from the study confirmed the negative screening results.

“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, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. Early screening can help identify individuals who need additional follow up or treatment.”

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