CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Nov. 16, 2022—PerkinElmer announced that the FDA has authorized the marketing of its Eonis SCID-SMA assay kit for in vitro diagnostic use by certified laboratories for the detection of spinal muscular atrophy and severe combined immunodeficiency in newborns. This is the first FDA-authorized assay for SMA screening in newborns in the United States, the company says, and is part of the company’s Eonis platform. The Eonis platform is a robust, flexible system that uses real-time PCR technology to screen for SMA and SCID using a single dried blood spot sample.