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Baebies Newborn Screening Assays for Galactosemia, Biotinidase Deficiency Get CE Mark

NEW YORK – Newborn and pediatric testing company Baebies said on Wednesday that its newborn screening assays for galactosemia and biotinidase deficiency have received the CE mark and are available in Europe and other geographies that recognize the CE mark.

The assays quantitatively measure the activity of galactose-1-phosphate uridylyltransferase and biotinidase enzymes from newborn dried blood spot specimens and run on the Durham, North Carolina-based company's Seeker platform, which was cleared by the US Food and Drug Administration in 2017. 

According to Baebies, though newborn screening for galactosemia and biotinidase deficiency is performed in many countries, a lot of newborns are not tested, and current screening methods have a complex testing workflow, long time to result, and are qualitative in nature. Its Seeker assays utilize digital microfluidic technology and require minimal hands-on time and no advanced training. Results can be achieved in two hours, and the assays are fully quantitative, Baebies said.

In December, the firm applied CE marking to its Finder platform for glucose-6-phosphate dehydrogenase testing.