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FDA Approves Newborn Screening Tests for Metabolic Disorders

FDA Approves Newborn Screening Tests for Metabolic Disorders
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MONDAY, Feb. 6, 2017 (HealthDay News) — A set of screening tests designed to detect four rare metabolic disorders in newborns has been approved by the U.S. Food and Drug Administration.

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, including 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 one of the four disorders in 73 of the screened newborns, the agency said.

The tests are produced by Baebies, based in Durham, N.C.

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