PerkinElmer Inc.'s kit to screen for a rare genetic disorder has been approved by the U.S. Food and Drug Administration, the first of its kind to test for Duchenne muscular dystrophy in newborns.
The U.S. regulator said the GSP Neonatal Creatine Kinase-MM kit can now be used by laboratories as part of a newborn screening panel to test for Duchenne muscular dystrophy, according to a Dec. 12 release.
Duchenne muscular dystrophy is characterized by progressive muscle degeneration and weakness, and is caused by the absence of a protein called dystrophin. The disease, which mainly affects boys, shows its symptoms in early childhood.
PerkinElmer's test measures the concentration of a specific protein in the blood called CK-MM, which increases when muscle damage occurs.
Higher levels of CK-MM may indicate the presence of Duchenne muscular dystrophy, the FDA said. The kit cannot be used for a definitive diagnosis of the disorder and results must be confirmed through other methods such as muscle biopsies and genetic tests.
The kit was evaluated under the FDA's de novo premarket review pathway, which allows submission for regulatory approval of novel, low-to-moderate-risk devices of a new type. The agency also established criteria outlining requirements for the verification, design validation and labeling for tests of this type.
Waltham, Mass.-based PerkinElmer provides solutions to the diagnostics, life sciences and applied services markets worldwide.