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Revvity Nabs CE-IVD Mark for Molecular Newborn Screening Platform

NEW YORK – Revvity said on Monday it has received a CE-IVD mark for a molecular testing platform that can be used to screen newborns for spinal muscular atrophy and severe combined immunodeficiency.

The Eonis Q platform includes the Eonis Q96 instrument — a real-time PCR instrument that analyzes dried blood spot samples and provides results in about three hours — and the Eonis SCID-SMA kit, which is designed for use on that instrument to identify SMA and SCID. Revvity said the Eonis Q workflow reduces hands-on time compared to conventional wet qPCR assays by eliminating wash steps and requiring fewer pipetting and centrifuging steps. It also uses fewer consumables and less plasticware, the firm said.

"Helping children get a healthier start to life is at the heart of our work, and making molecular testing for inherited conditions like SMA and SCID more accessible can help further that aim," Petra Furu, general manager of reproductive health for Revvity, said in a statement. "Without compromising quality, speed, or test result accuracy, the Eonis Q system is designed to break down some of the common barriers that prevent newborn screening labs from adopting these tests."

The firm noted that the advocacy organization European Alliance for Newborn Screening in Spinal Muscular Atrophy is pushing for universal SMA screening in Europe by 2025. Authorities in many European countries have been developing national screening programs or conducting pilot programs. About 98 percent of infants born in the US are screened for SMA through state public health programs.