PerkinElmer Receives FDA Clearance for World’s First Tandem Mass Spectrometry Newborn Screening System
PerkinElmer, Inc., a leading provider of drug discovery, life science research and analytical solutions, today announced that it has received clearance from the U.S. Food and Drug Administration for its NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit. PerkinElmer now has the world’s first kit cleared by the FDA for use in the global standardization of Metabolic Screening with Tandem Mass Spectrometry.
— Kit Screens for Metabolic Disorders; Enables Early Detection and Intervention
— Analyzes More Than 40 Disease Markers with a Single Blood Sample
Newborn screening for metabolic disorders has become one of the most widely accepted procedures in preventative pediatrics. From a single newborn heel-stick blood sample, PerkinElmer genetic screening tools are used to screen for a variety of metabolic disorders. Early detection increases treatment and management options, leading to an improved quality of life.
“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. “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. Early intervention and treatment can improve health, lower healthcare costs and save lives.”
The FDA cleared the test based on an epidemiological study of blood samples analyzed using both current testing methods and the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit.
PerkinElmer is the world’s leading supplier to newborn screening laboratories. Every baby screened in the United States today is tested using PerkinElmer’s genetic screening tools. Approximately 20 percent of the world’s infants currently receive some type of newborn screening, and approximately 65 percent of those are screened using PerkinElmer genetic screening products. www.perkinelmer.com
