Bionano Genomics Launches CLIA-Certified Laboratory, First OGM-Based Test
Bionano Laboratories will offer services to clinical customers seeking to implement OGM for routine diagnostic use.
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.
Jan 28, 2019