FDA Advisors Back Approval of Baebies’ SEEKER Analyzer for Newborns

An FDA advisory committee unanimously agreed that Baebies’ Seeker analyzer should be approved to detect lysosomal enzymes in newborns. After originally expressing concern about false positives and negatives, the committee ultimately decided that the benefits outweighed the risk.
http://baebies.com/fda-advisors-back-approval-baebies-seeker-analyzer-newborns/