Developmental Delays

FDA clears new lab test to help screen newborn infants for congenital disease

Published in Medical Letter on the CDC and FDA, September 26th, 2004

The U.S. Food and Drug Administration (FDA) has cleared for marketing a new laboratory blood test that will help doctors screen newborn infants for a variety of inherited diseases.

The test is done on blood from newborn heel-stick samples - the same kind of sample used for state-mandated newborn screening tests. The blood sample is measured for levels of amino acids and substances called free carnitine and acylcarnitines.

While small amounts of these substances are found in everyone, abnormally high amounts, or abnormal patterns, may indicate different disease states called inborn errors of metabolism. They include, but are not limited to,...

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Source: Medical Letter on the CDC and FDA (2004-09-26)

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