Baebies is Global

Expecting families in Qatar will soon have access to screen their babies for lysosomal storage disorders (LSDs) including Pompe disease, MPS I, Fabry and Gaucher. Qatar’s newborn screening lab is getting up and running with Baebies SEEKER, the first FDA-cleared and CE-marked newborn screening platform for LSDs.

Celebrating Shipment of 3,000,000th Test!

Baebies is celebrating the shipment of more than 3 million tests which translates to more than 3 million chances for a healthy start. We proudly share this milestone and our growth with babies everywhere.

Newborn Screening Legislation Expands Test Panels in Several US States

Missouri will be the first state in the US to screen for mucopolysaccharidosis II (MPS II), otherwise known as Hunter syndrome and spinal muscular atrophy (SMA), two life threatening genetic diseases. The state is already screening for several LSDs using the SEEKER platform. Florida recently passed legislation that requires the Advisory Council to consider every condition added to the RUSP within 1 year, and if recommended, the NBS lab would be required to screen for that condition within 18 months.

FDA Advisors Back Approval of Baebies’ SEEKER Analyzer for Newborns

An FDA advisory committee unanimously agreed that Baebies’ Seeker analyzer should be approved to detect lysosomal enzymes in newborns. The Clinical Chemistry and Toxicology Devices Panel had originally expressed concerns about false positives and negatives associated with the diagnostic test, but it ultimately decided that the benefits outweighed the risk and the Instruction for Use statement could indicate the limitations. Baebies is seeking a de novo classification for the system, which includes the Seeker analyzer, the Seeker 4-plex assay kit, Seeker cartridges, the Spot Logic software and quality control materials. The diagnostic uses digital microfluidic technology to measure lysosomal enzymes associated with Mucopolysaccharidosis Type 1 disease, Pompe disease, Gaucher disease and Fabry disease.