Baebies Announces CE Mark for SEEKER, an Innovative Newborn Screening Platform for Lysosomal Storage Diseases
DURHAM, N.C., July 31, 2017 – Baebies is pleased to announce that SEEKERTM, a high throughput newborn screening laboratory solution, now has CE Mark and available in Europe and other countries that recognize CE Mark. SEEKER quantitatively measures the activity of lysosomal enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry disease.
Newborn screening for lysosomal storage diseases (LSDs) has gained interest worldwide with the increasing availability of effective treatment options and accessible screening methods. In addition, several recent studies have highlighted higher incidence rates for certain LSDs than previously reported. “SEEKER’s ease of use enables the platform to be used in virtually any newborn screening program,” says Jerry Walter, Founder and President of the National Fabry Disease Foundation. “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,” says Jan Østrup, a pioneer in neonatal screening product development and a member of the Baebies’ Scientific Advisory Board.
"We are delighted to announce CE Mark for SEEKER," said Richard West, Co-Founder and Chief Executive Officer of Baebies. "There is a tremendous interest in SEEKER outside the US due to its simple implementation and we are actively engaged with several customers," added West.
As countries start or expand newborn screening programs, labs are challenged to find easy and cost-efficient ways to implement new assays. To address these needs, Baebies delivers SEEKER, a reliable, fast and easy to use solution for high throughput newborn screening. The pioneering platform features:
- Digital microfluidic technology which minimizes sample and reagent volumes.
- Minimal, easy to use equipment making installation and training quick and simple.
- All electronic workstation with no required daily maintenance so the platform is always up and running.
- Proprietary software that guides all skill levels through the minimal hands-on workflow.
Baebies’ SEEKER received U.S. FDA authorization in February 2017 after a thorough review that included a clinical study of over 150,000 subjects, with no known false negatives reported. For more information on Baebies’ SEEKER platform, visit www.baebies.com.
SEEKER is a high throughput laboratory solution that quantitatively measures the activity of lysosomal storage enzymes from newborn dried blood spot specimens. As the first newborn screening platform for lysosomal storage disorders authorized by the U.S. FDA, SEEKER is designed for ease of use, simple implementation and no daily maintenance.
At Baebies our sole focus is to advance newborn screening and other pediatric testing worldwide. Baebies is guided by the vision that “everyone deserves a healthy start”. Baebies delivers innovative products and services to make life better for millions of babies. By bringing new technologies and new tests to the healthcare community, Baebies is providing hope to parents and the chance at a better life to newborns. Baebies SEEKER is the only newborn screening platform for authorized by the U.S. FDA for lysosomal storage diseases. For more information visit www.baebies.com.