muscular dystrophy
Ortho Clinical Diagnostics, Hangzhou AllTest Biotech, Others Obtain FDA Clearances in January
Ortho got the green light for a reagent pack used to measure creatine kinase myocardial band on the firm's Vitros 3600 Immunodiagnostic System.
Brigham and Women's Hospital Partners With CureDuchenne on Newborn Screening Program
Brigham and Women's will offer at no cost a blood test that detects elevated levels of an enzyme associated with Duchenne muscular dystrophy.
PerkinElmer Newborn Screening Assay Receives CE-IVD Mark
The company's Eonis assay, which leverages RT-PCR technology, can be used to simultaneously tests for SMA, SCID, and XLA in newborns.
PerkinElmer is providing its recently FDA-approved test for the program, which has identified one baby, so far, as positive for DMD.
PerkinElmer's Muscular Dystrophy Screening Kit Receives FDA Marketing Authorization
The company's GSP Neonatal Creatine Kinase-MM kit measures the CK-MM protein and is the first test to help in newborn screening for Duchenne Muscular Dystrophy.Â