www.fdanews.com/articles/197335-baebies-genetic-screening-assay-receives-ce-mark
Baebies’ Genetic Screening Assay Receives CE Mark
May 29, 2020
Newborn screening and pediatric test developer Baebies has received a CE mark for assays that screen for two genetic disorders.
The galactosemia and biotinidase deficiency assays, which run on the company’s Seeker screening platform, use dried blood-spot specimens to detect reduced enzyme activity in newborns.
The Durham, N.C.-based company is launching the assays in Europe and other countries that recognize the CE mark.