Multiple analytes tested from single low-volume sample lead to improved health outcomes.
Baebies was recently awarded a Phase IIB SBIR grant from the National Institutes of Health (NIH) for a project to focus on developing a more comprehensive screening method for hyperbilirubinemia (HBR) in newborns. Neonatal HBR (jaundice) occurs in more than half of all newborns and when left untreated, can lead to irreversible, severe neurological dysfunction. Rapid identification of newborns at risk of HBR is critical. There is currently no uniform standard of care that includes identification of multiple risk factors for HBR in newborns.
This project focuses on continued development of a panel of tests to comprehensively identify newborns at risk of severe hyperbilirubinemia more quickly prior to discharge from the hospital. The test panel includes simultaneous testing of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity, total serum bilirubin and albumin, on a single near-patient platform from a small volume of whole blood (50 µL). The results of the panel provide a comprehensive assessment of HBR risk in newborns with a total testing time of 15 minutes.
The platform and tests were fully developed in collaboration with leading neonatologists and bilirubin experts at Stanford and Duke Universities. The tests have undergone preliminary analytical evaluation and this awarded grant will support clinical validation for regulatory review.
The grant (R44HD072853) was awarded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which is a part of the National Institutes of Health. Phase IIB awards provide additional funding to help bridge the gap between R&D and commercialization. Combined with the successfully completed Phase I and II project periods, this HBR screening project has received a total of $3.8M in NIH grant funding.
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