Durham, N.C. – (March 18, 2021) – Baebies, a growth-stage company developing innovative products to provide a healthy start for children everywhere, today announced that it has reached a significant milestone by delivering 10 million tests to newborn screening labs around the world since the company was founded. In 2017, Baebies SEEKER® became the first FDA-authorized newborn screening platform for lysosomal storage disorders. Currently, 1 in 7 babies born in the U.S. are screened using SEEKER.
“This milestone translates to 10 million chances to save a life,” said Richard West, co-founder and Chief Executive Officer of Baebies. “While these diseases are rare, screening at birth is the fastest path to treatment and the best possible start in life. In our daily work, our team has had the privilege of meeting families with children who are alive and well today thanks to newborn screening. There is no greater testament to the importance of our work.”
SEEKER tests for four lysosomal storage disorders including Mucopolysaccharidosis type I (MPS I), Pompe, Fabry and Gaucher diseases; both MPS I and Pompe are currently on the federal Recommended Uniform Screening Panel. Powered by digital microfluidics (DMF) technology, SEEKER performs multiple assays at the same time using just one punch from a newborn dried blood spot specimen. DMF is a method to programmably manipulate tiny droplets of liquid by electrical control of surface tension on a disposable cartridge.
“Digital microfluidics technology brings unique benefits to newborn screening and diagnostics,” said Vamsee Pamula, co-founder and President. “The flexibility and expandability of our small, portable DMF platforms are key factors that drive and accelerate our global distribution – helping us realize our mission to ensure a healthy start to everyone. We delivered 3 million of the 10 million tests in just the last 12 months to states across the U.S. and multiple countries.”
In furthering Baebies’ mission, FINDER® – featuring a toaster-sized instrument and a disposable cartridge for near-patient testing also powered by DMF technology – was launched with a CE mark and is currently under FDA 510(k) review. FINDER tests for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic defect leading to anemia and severe jaundice. FINDER can efficiently test for G6PD deficiency from low blood volume (50 µL) with a turn-around time of approximately 15 minutes after sample introduction. Baebies recently won the AACC Disruptive Technology Award for FINDER in a tight competition emerging as the next innovative testing solution that will transform patient care.
- Learn more about SEEKER
- Publication: Lessons Learned from Pompe Disease Newborn Screening and Follow-up
- Blog Post: 5 Things to Know about Testing with Digital Microfluidics
- Publication: A Novel Point-of-care Device for Measuring Glucose-6-phosphate Dehydrogenase Enzyme Deficiency
- White Paper: Do More With Less: Approaches to Minimize Blood Loss in Critically Ill Newborns and Children