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Newborn Screening Assay Will Get Questions On False-Positive Rates By FDA Panel

 
• By Sue Darcey

FDA's Clinical Chemistry and Clinical Toxicology Devices Panel will meet Aug. 10 to address Baebies Inc.'s submission for its Seeker newborn screen to detect lysomal storage disorders. One issue on the US agency's mind in the lead-up to the meeting is how false-positive rates were determined.

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 dried blood samples. There is currently no screening test that has been cleared in the US to screen babies with lysomal storage disorders, and Baebies' offering might fill an important medical gap

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