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