Tandem Mass Spectrometry System Screens Newborns

The NeoGram acids and acylcarnitines mass spectrometry kit has been cleared by the U.S. Food and Drug Administration (FDA).

Newborn screening for metabolic disorders is a widely accepted procedure in preventative pediatrics. From a single newborn heel-stick blood sample, genetic screening tools screen for a variety of metabolic disorders. Early detection increases treatment and management options, leading to an improved quality of life. The FDA clearance of the test was based on an epidemiologic study of blood samples analyzed by both current testing methods and the new tandem mass spectrometry kit.

"FDA clearance of this kit means there is a powerful new tool available to protect the health of newborns,” said Peter Coggins, Ph.D., president of PerkinElmer Life and Analytical Sciences (Boston, MA, USA), which developed the kit. "By testing for multiple disorders from a single sample, this technology provides a timely and very cost-effective approach to identifying newborns at risk for life-threatening metabolic disorders.”




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