PerkinElmer Inc. won 510(k) clearance from the Food & Drug Administration for its a device that screens newborn infants for genetic disorders.
The Waltham, Mass.-based diagnostics maker said the FDA approved its GSP Genetic Screening Processor. The device is designed to let testing labs perform multiple diagnostics from a single, small blood sample. So far, the FDA has only approved an assay for neonatal thyrotropin, a hormone secreted by the pituitary gland that helps regulate the thyroid. PerkinElmer said it’s working on several other assays for the device.
Third-quarter earnings slumped for the company, with slower sales and restructuring costs catching much of the blame for the decline.
Overall sales fell 9 percent to $437.1 million during the three months ended Sept. 30, down from $478.8 million a year ago. Net income was $13.6 million, or 14 cents per share, off $38.3 million from the $51.9 million, 35 cents-per-share profit reported for the third quarter of 2008.