Baebies Announces CE Mark for Newborn Screening Assays for Galactosemia and Biotinidase Deficiency on SEEKER

Durham, N.C. – (May 27, 2020) – Baebies, a growth-stage company developing diagnostic products to provide a healthy start for children everywhere, announced today that it has met all requirements for CE mark under the IVD Directive (98/79/EC) for newborn screening assays on SEEKER® for galactosemia and biotinidase deficiency. Powered by digital microfluidics technology, SEEKER quantitatively measures the activity of galactose-1-phosphate uridylyltransferase and biotinidase enzymes from newborn dried blood spot specimens. Reduced activity of these enzymes may be indicative of classical galactosemia and biotinidase deficiency. These assays are now commercially available in Europe and other countries that recognize CE mark.

Galactosemia and biotinidase deficiency are genetic disorders that are currently screened for at birth in over fifty countries. Newborn screening enables early diagnosis and treatment, leading to better health outcomes. Treatment for these disorders is inexpensive and easily administrated through pharmaceutical or nutritional intervention that can be leveraged quickly after diagnosis.

While newborn screening for galactosemia and/or biotinidase deficiency exists in many countries, a large number of newborns are still not tested for these conditions and the current screening methods pose various challenges. These challenges include high complexity of workflow, long time to result, and qualitative versus quantitative assays. Baebies’ SEEKER features:

  • digital microfluidic technology
  • minimal hands-on time and no advanced training required
  • screening results in just two hours
  • fully quantitative assays
  • both tests from a single dried blood spot punch
  • expandable test menu on the same easy-to-use platform

“CE mark for additional newborn screening assays on SEEKER is an important milestone for our team,” said Richard West, Co-Founder and Chief Executive Officer of Baebies. “We look forward to partnering with more newborn screening programs around the world through this expansion of assays on SEEKER.”

In 2017, Baebies’ SEEKER was granted De Novo authorization from the U.S. FDA and CE mark for newborn screening of four lysosomal storage disorders including mucopolysaccharidosis type I (MPS I), Pompe, Gaucher and Fabry diseases. SEEKER is used to test thousands of babies each day around the world.

Newborn screening assays for galactosemia and biotinidase deficiency on SEEKER are not currently available for sale in the United States.

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