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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...

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• By Natasha Barrow

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• By Brian Bossetta

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• By Elizabeth Orr

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FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

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More from North America

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Bone Surgery Startup Surgify Medical Raises $7.9m

 
• By Natasha Barrow

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German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.