FDA Approves Newborn Screening Tests for Metabolic Disorders

Share this content:
FDA Approves Newborn Screening Tests for Metabolic Disorders
FDA Approves Newborn Screening Tests for Metabolic Disorders

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.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions


Sign up for myCME e-newsletters


More in Home

Aspirin, Rivaroxaban Similar After Total Hip, Knee Arthroplasty

Aspirin, Rivaroxaban Similar After Total Hip, Knee Arthroplasty

Extended prophylaxis with aspirin no different from rivaroxaban for preventing venous thromboembolism

Odds of ARDS Up After Cardiac Surgery During Flu Season

Odds of ARDS Up After Cardiac Surgery During ...

Cardiac surgery during flu season is independent risk factor for acute respiratory distress syndrome

In A-Fib Patients, Stroke Risk Higher for Blacks Than Whites

In A-Fib Patients, Stroke Risk Higher for Blacks ...

Higher risk of ischemic stroke seen before, after atrial fibrillation diagnosis compared with whites

is free, fast, and customized just for you!

Already a member?

Sign In Now »