PerkinElmer’s Screening Kit Receives the FDA’s Approval as the First Test to Aid in Newborn Screening for Duchenne Muscular Dystrophy

PerkinElmer's Screening Kit Receives the FDA’s Approval as the First Test to Aid in Newborn Screening for Duchenne Muscular Dystrophy

Shots:

  • The US FDA has granted De Novo marketing authorization to PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit based on the clinical study evaluating 3,041 newborns whose dried blood samples showed genetic mutations linked to DMD and the test clinically confirmed 30 samples to have DMD
  • The test act by measuring the level of CK-MM from the dried blood samples collected from the prick of a newborn’s heel 24-48 hrs. after birth. Elevation in CK-MM level indicates the presence of DMD
  • 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. The test can provide false negatives, so any results must be confirmed via muscle biopsies/ genetic or lab tests

Click here to­ read full press release/ article | Ref: FDA | Image: PerkinElmer