A new blood test approved Wednesday by the Food and Drug Administration could identify newborns with diseases linked to developmental delays, seizures, mental retardation and death.
Each state already screens the blood of newborns. The new lab test would use those heel-stick samples to screen for worrisome levels of amino acids and other diagnostic substances. Abnormally high amounts of the targeted substances can hint at a cluster of problematic diseases. Treating those diseases even earlier could improve the newborn's quality of life.
FDA approval came after a large, multicenter epidemiological study of blood samples from more than 200,000 babies. The new test, NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, is manufactured by Norton, Ohio-based PerkinElmer Life and Analytical Sciences.
