NEW YORK – Newborn and pediatric testing firm Baebies announced on Tuesday it has applied CE marking to its Finder platform for glucose-6-phosphate dehydrogenase testing.
The Durham, North Carolina firm applied the CE mark to the Finder instrument and cartridge, which includes tests for G6PD from a drop of whole blood. The near-patient platform has a turnaround time of about 15 minutes after sample introduction, it said in a statement.
The company added that Finder can be used in a variety of settings including hospital nurseries, laboratories, neonatal intensive care units, and birthing centers. It features digital microfluidic technology, which minimizes ample and reagent volumes. Along with G6PD, Finder is being developed to determine levels of total serum bilirubin and albumin, it said on its website.
The company is currently performing a clinical trial for Finder in preparation of a 510(k) submission to the US Food and Drug Administration, anticipated in early 2020.
G6PD deficiency affects about 400 million people globally and can cause a variety of ailments, such as jaundice, acute hemolysis, and chronic hemolysis, Baebies noted, adding a test utilizing low volumes of blood is especially needed to test critically ill newborns and children undergoing intensive care.