Newborn Screening Platform for Lysosomal Storage Diseases Granted CE Mark in Europe

Newborn Screening Platform for Lysosomal Storage Diseases Granted CE Mark in Europe

Baebis recently announced that Seeker, the company’s novel newborn screening laboratory platform designed to measure the activity of lysosomal enzymes from newborn dried blood specimens, has been granted a CE Mark and is now available in Europe and in all countries that recognize CE Mark.

Reduced activity of lysosomal enzymes could be indicative of Gaucher disease, Fabry disease, Pompe disease, and mucopolysaccharidosis Type I (MPS I), which together form a group of diseases known as lysosomal storage diseases (LSDs).

LSDs are a consequence of malfunctioning enzymes that trigger the accumulation of toxins inside cells, resulting in a harmful accumulation, particularly in neurons, that might lead to learning, development and movement problems.

Even though the benefits of newborn screening for LSDs has not yet been completely proven, the practice has gained increasing interest in the recent years as treatment options and screening methods become more accessible.

Screening for LSDs could lead to early detection and, as a result, children would be able to receive appropriate treatment before the harm caused by the diseases is irreparable.

Baebies’ Seeker lab platform received de novo clearance from the U.S. Food and Drug Administration (FDA) in February 2017, after the agency reviewed clinical data on over 150,000 subjects with no known false negatives reported. Seeker was designed for ease of use, simple implementation and no daily maintenance.

A de novo classification offers an alternative pathway to classify novel types of medical devices of low-to-moderate risk. The FDA approved the system for the screening of the four LSDs mentioned above, making Seeker the first newborn screening test available for these disorders.

Seeker was also designed to be cost-efficient. The platform offers digital microfluidic technology that minimizes sample and reagent volumes, minimal equipment to make installation and training as easy as possible, and proprietary software that guides all skill levels.

“Seeker’s ease of use enables the platform to be used in virtually any newborn screening program,” Jerry Walter, founder and president of the National Fabry Disease Foundation, said in a press release. “More babies screened for LSDs means more babies identified and diagnosed through clinical follow-up.”

“As a company focused on newborn screening and pediatric testing, Seeker’s CE Mark allows Baebies to build on the mission that everyone deserves a healthy start by expanding access to newborn screening to all babies around the world,” added Jan Østrup, a member of the Baebies’ Scientific Advisory Board.

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