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US FDA Grants de Novo Clearance for Baebies' Lysosomal Storage Disease Newborn Screening Platform.

M2 PHARMA-February 8, 2017-US FDA Grants de Novo Clearance for Baebies' Lysosomal Storage Disease Newborn Screening Platform

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- US-based newborn screening and pediatric testing company Baebies has received de novo clearance from the US Food and Drug Administration for its Seeker platform, the company said.

Seeker quantitatively measures the activity of lysosomal enzymes ?-L-iduronidase, ?-D-glucosidase, ?-glucocerebrosidase and ?-D-galactosidase A from newborn dried blood spot specimens.

Reduced activity of these enzymes may be indicative of lysosomal storage diseases Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry, respectively.

Newborn screening, widely recognised as one of the most successful public health programmes in the US, ensures that all babies are screened for certain serious conditions at birth.

This programme started more than 50 years ago and has since expanded to include more than 30 metabolic and genetic diseases.

The recent addition of Pompe disease and MPS I to the Recommended Uniform Screening Panel have brought more recognition to the benefit of early detection through newborn screening for LSDs.

Baebies' sole focus is to advance newborn screening and other pediatric testing worldwide.

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Publication:M2 Pharma
Date:Feb 8, 2017
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