FDA: The U.S. Food and Drug Administration today 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.