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Baebies gets FDA nod for metabolic disorders screening system in newborns

Published 06 February 2017

Baebies has secured approval from the US Food and Drug Administration (FDA) to market its newborn screening system for detection of four lysosomal storage disorders (LSDs).

The system has been designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher and Fabry disorders, where enzymes (proteins) that usually eliminate unwanted substances in cells do not function normally.

If the disorders are not detected at an early stage, it can lead to organ damage, neurological disability or even death.

The US Department of Health and Human Services’ Advisory Committee Heritable Disorders in Newborns and Children says that these disorders can be found, 1 in 1500 to not more than 1 in 186,000 newborns and children, depending on the disorder.

At present, several states in the US including Arizona, Illinois, Kentucky, Michigan, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania and Tennessee have made it mandatory to screen all newborns for LSDs. However, until now, there were no FDA-approval devices to detect these disorders.

The Seeker System features LSD Reagent Kit- IDUA|GAA|GBA|GLA and it works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth.

The FDA reviewed the system through a clinical study consisting of 154,412 newborns, whose dried blood samples were tested for protein activity associated with MPS I, Pompe, Gaucher and Fabry.

Efficacy was determined because the system was able to accurately identify at least one of each of these four LSDs in 73 of the screened newborns. However, the FDA has also noted that the system can sometimes be prone to false negatives.

FDA Center for Devices and Radiological Health, In Vitro Diagnostics and Radiological Health Office director Alberto Gutierrez said: “The Secretary of HHS recently added Pompe and MPS I to the list of routine recommended newborn screening programs and it is anticipated that additional states will begin requiring use of screening tests to detect these disorders.

“Accurate screening tests will help with early detection, treatment and control of these rare disorders in newborns, before permanent damage occurs. That’s why availability of LSD screening methods that have been assessed for accuracy and reliability by the FDA are so important.”

The Seeker System was developed with funding from the Small Business Innovation Research program in National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development.