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PerkinElmer Newborn Metabolic Testing Kit Cleared by FDA

NEW YORK (360Dx) – PerkinElmer announced today that the US Food and Drug Administration has cleared its NeoBase 2 Non-Derivatized MSMS kit for testing newborns for metabolic disorders with a single dried blood spot.

The in vitro diagnostic kit is for use with a mass spectrometer and quantitatively measures and evaluates traditionally screened amino acids and acylcarnitines, succinylacetone, free carnitine, nucleoside, and lysophospholipid concentrations. It measures up to 51 analytes, including markers for screening of X-linked adrenoleukodystrophy and adenosine deaminase severe combined immunodeficiency.

Waltham, Massachusetts-based PerkinElmer said the NeoBase2 kit enables labs to use a three-step assay workflow, compared to the 12 steps that a derivatized assay typically requires.

"Earlier detection can lead to faster treatment of patients, and this is especially critical for the millions of babies around the world," PerkinElmer General Manager of Mass Spectrometry Naren Bhat said in a statement. "Laboratories, therefore, face increasing pressure to accurately detect disorders faster — and need a solution that will expand their screening capabilities and reduce false positive rates without adding extra equipment or expending resources. PerkinElmer’s FDA-cleared NeoBase 2 kit offers shorter extraction time, incubation time and run time, to help laboratories detect potential health risks sooner."