This federal Project Grant award from the National Institute of Child Health and Human Development (NICHD), under the Child Health and Human Development Extramural Research program (CFDA 93.865), will fund the design and preparation of diagnostic biomarker reference standards for mucopolysaccharidosis type I (MPS-I) and type II (MPS-II). These lysosomal storage disorders are included in newborn screening programs, but current first-tier enzyme activity screening has a high rate of false positives. The $272,872 award to Gelbchem, LLC will develop glycosaminoglycan (GAG) biomarker reference standards that meet FDA recommendations, enabling accurate discrimination of diagnosed newborns from the healthy reference range through second-tier screening. This will provide clinical diagnostic laboratories with the necessary materials to validate the endogenous GAG biomarker method for MPS-I and MPS-II.
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