HealthDay News — The US Food and Drug Administration has approved a set of screening tests designed to detect four rare metabolic disorders in newborns.
The “Seeker” system of diagnostics is designed to screen for Mucopolysaccharidosis Type 1, Pompe, Gaucher and Fabry. These are the first tests approved to screen for the inherited disorders, the FDA said in a news release.
Some states now require screening of these disorders, the agency said.
These include Arizona, Illinois, Kentucky, Michigan, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania and Tennessee.
The newly approved tests require blood samples collected from the prick of a newborn’s heel within 48 hours of birth. The FDA said it reviewed data from a clinical study of more than 154,000 infants in Missouri.
The system identified at least 1 of the 4 disorders in 73 of the screened newborns, the agency said.
The tests are produced by Baebies, based in Durham, NC.
FDA Permits Marketing of First Newborn Screening System for Detection of Four, Rare Metabolic Disorders [press release]. Silver Spring, MD: US Food and Drug Administration; February 3, 2017.