• Safi Bello

FDA Permits Marketing Of First Newborn Screening System For Detection Of Four, Rare Metabolic Disord

U.S. Food & Drug Administration press release -- On Friday February 3, 2017 The FDA permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher and Fabry. It is the first newborn screening test permitted to be marketed by the FDA for these disorders. LSDs are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body's cells are not at normal levels or functioning properly. According to the U.S. Department of Health and Human Services' Advisory Committee on Heritable Disorders in Newborns and Children, MPS I, Pompe, Gaucher and Fabry occur in approximately 1 in 1,500 to no more than 1 in 185,000 newborns and children, depending on the disorder. If not detected and treated in a timely manner, these disorders may cause organ damage, neurological disability or death. To learn more about the FDA permitting marketing of first newborn screening system for detection of four, rare metabolic disorders click on the picture below to read the FDA release.

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