PerkinElmer Gets FDA 510K OK for Newborn Screening Platform

PerkinElmer, Inc., a global company focused on the health and safety of people and the environment, announced that the Company has received 510K clearance from the U.S. Food and Drug Administration for its GSP Genetic Screening Processor, which is used by public health laboratories worldwide as part of newborn screening programs.

In a release, the Company noted that in newborn screening programs, infants are tested for a range of genetic, metabolic or hematologic disorders. When identified within the first few days of life, these disorders are often easily managed, but if left untreated, could lead to serious illness or even death. The testing process begins with the collection of a few drops of blood from a heel prick.

The Company said that the GSP system makes it much easier for labs to analyze newborn blood samples by providing the capability to run more than one test at once on very small samples. The GSP is an automated platform able to quantitatively and qualitatively analyze blood spot samples for irregularities associated with metabolic diseases that when detected early, can often be easily treated. With multi-analyte analysis capability and a two-fold capacity over prior systems, the GSP system delivers increased efficiency and flexibility over other methods, while reducing the risk of errors associated with manual processing of samples.

"FDA approval of PerkinElmer's GSP system provides laboratories in the U.S. with a next-generation system that can help address the staffing and workflow needs of today's demanding environment," said Ann-Christine Sundell, president, Genetic Screening, PerkinElmer. "This achievement reflects our ongoing commitment, as the global leader in newborn screening, to improving medical outcomes by developing the highest quality newborn screening solutions."

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