Baebies today said it received CE Mark for its Finder near-patient testing platform.
Finder is an in vitro diagnostic device (IVD) that features an instrument and cartridge that can test for Glucose-6-Phosphate Dehydrogenase from low blood volume, or a single drop of whole blood. It can provide results within 15 minutes after sample introduction.
“The ability to perform G6PD testing with a near-patient device would have a major impact on our ability to manage hyperbilirubinemia,” Vinod Bhutani, professor of pediatrics and neonatology at Stanford University, said in a news release. “This would be especially valuable in areas of the world with high percentages of Africa, Asian, Mediterranean or Middle-Eastern descent, to provide a comprehensive profile of treatment and avoidance of stressors.”
Finder can be used in a number of settings, including hospital nurseries, laboratories, neonatal intensive care units and birthing centers. It also features digital microfluidic technology that minimizes sample and reagent volumes; a small footprint at 8 in. wide with a tablet; simple workflow with one user step to load a sample and all necessary reagents onboard the cartridge.
“As a company focused on newborn screening and pediatric testing, Finder’s CE Mark allows Baebies to continue to work towards our mission, that everyone deserves a healthy start, by expanding access of testing to more babies around the world,” CEO and cofounder Richard West said.
Baebies plans to complete a clinical trial of the device in early 2020 for FDA 510(k) submission. It is currently undergoing a clinical trial for FDA clearance.