Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.
Roughly 10% of newborns require some form of assistance at birth, and 1% need major resuscitative efforts. The time to help one of these babies can be measured in minutes, so having the right specialist on hand can have a huge impact on the child's outcome. Six-and-a-half years ago, the Mayo Clinic launched the Newborn Resuscitation Telemedicine Program (NRTP) to offer telemedicine consults to community hospitals within its health system during high-risk neonatal resuscitations. The program has been successful in reducing unnecessary transfers and growing the number of patient referrals to Mayo Clinic.
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