An FDA advisory panel on Aug. 10 will review a de novo classification petitionfrom Baebies Inc. for its newborn screening device to detect lysomal storage disorders, and the advisors are expected to focus closely on the false-positive rate for the test seen in a pivotal study.
Specifically, the firm's Seeker Systemand Seeker Reagent Kitwasdeveloped to detect reduced levels of multiple lysomal enzymes in infants based on...
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