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Print Edition StoriesThursday, November 5, 2009
PerkinElmer newborn screening platform gets FDA clearance
By Mass High Tech staff
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Waltham-based lab and research gear provider PerkinElmer Inc. has been granted 510K clearance from the U.S. Food and Drug Administration for its GSP Genetic Screening Processor, part of newborn screening programs.
The GSP, used in public health laboratories, tests infants for genetic, metabolic or hematologic disorders. It analyzes samples on the spot, rather than in batches, allowing for faster results.
PerkinElmer officials have said that the company is working on other newborn screening assays, though its GSP Neonatal TSH assay is the first to land FDA clearance.
PerkinElmer (NYSE: PKI) reported revenue of approximately $2 billion in 2008. It has some 8,500 employees with customers in over 150 countries. The company makes instruments and consumables for pharmaceutical and biomedical companies.
In September, PerkinElmer announced it had expanded its prenatal and neonatal diagnostic offerings globally by acquiring Shanghai-based diagnostics supplier SYM-BIO Lifescience for about $63.7 million.
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