PerkinElmer’s EONIS Screening Assay Gets CE-IVD Clearance

PerkinElmer’s EONIS newborn screening assay has won a CE mark certification in Europe to screen for spinal muscular atrophy (SMA), severe combined immunodeficiency (SCID) and X-linked agammaglobulinemia (XLA).

SMA is one of the most common deadly genetic conditions and is associated with significant motor disability and respiratory problems. SCID, also known as “Bubble Boy” disease, and XLA are rare conditions in which the immune system is unable to fight off infections.

The EONIS system uses five steps to identify the three disorders, including sample collection, punching, DNA extraction, amplification and data analysis using dedicated software.