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FDA Panel Supports Baebies' Seeker Newborn Screen Test

 
• By Sue Darcey

The US agency's Clinical Chemistry and Clinical Toxicology Devices panel showed support Aug. 10 for a de novo submission by Baebies Inc. on its Seeker System for newborn screening for lysomal storage disorders. Panelists said the need for the newborn screen outweighed the uncertainties in setting cutoff points and false-positive/false-negative rates.

Despite observing problems with the way cutoff points and false-positive and negative-rates were established in a pivotal study of Baebies Inc.'s Seeker System, a US FDA advisory panel decided that the medical need for the unique screening system outweighed its weaknesses.

Members of the Clinical Chemistry and Clinical Toxicology Devices panel discussed at length the precision of Baebies' screen in finding an exact cutoff point for determining if infants had lysomal...

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