FDA approves marketing of test to screen newborns for Duchenne

The FDA Dec. 12 approved the marketing of a device used to detect Duchenne Muscular Dystrophy in newborns. 

The device, made by PerkinElmer, a Waltham, Mass.-based company that specializes in detecting health issues, is designed to allow healthcare providers to discover Duchenne in patients at an earlier age. 

Duchenne is a rare genetic disorder that causes progressive muscle deterioration and weakness. People typically notice the first symptoms of it in infants between the ages of 3 and 5, and symptoms worsen over time. 

Patients with Duchenne lose the ability to perform activities independently and often require a wheelchair by their early teens. As the disease progresses, life-threatening heart and respiratory conditions tend to occur. 

A typical life expectancy for someone with Duchenne is 20 to 30 years. Early diagnosis of the disease could lead to more personalized care for patients, which could extend life expectancy. 

PerkinElmer's device, called the GSP Neonatal Creatine Kinase-MM kit, works by measuring an infant's blood's concentration of a protein called CK-MM, which enters the bloodstream in increased amounts when there is muscle damage. Elevated levels of the protein could indicate Duchenne, but must be confirmed by other testing methods. 

Read the full news release here

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