The Food and Drug Administration gave market clearance for the Seeker System, a screening test designed to detect four metabolic disorders in newborns.
The system can detect Mucopolysaccharidosis Type I, Pompe disease, Gaucher disease and Fabry disease — a rare inherited disorder in which proteins in charge of eliminating unwanted substance's from the body's cells do not function properly.
To detect the diseases, the Seeker System measures the activity level of specific proteins in dried blood samples collected from the prick of an infant's heel up to 48 hours after birth, reports the FDA.
Durham, N.C.-based Baebies created the Seeker System, with the help of funding from the Small Business Innovation Research program in National Institutes of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development.
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