BAEBIES, INC. — Department of Health and Human Services SBIR Phase II: NICHD

Description

ABSTRACT Multiplex Platform for Point of Care Newborn Screening of Hyperbilirubinemia PAR Neonatal jaundice is a frequent condition which when unmonitored or untreated can lead to severe neonatal hyperbilirubinemia HBR and associated morbidities Following guidelines set by the American Academy of Pediatrics most babies in the U S are screened for hyperbilirubinemia by testing bilirubin levels as part of routine newborn screening which identifies those neonates most at risk for progressive HBR Testing is performed near the patient due to bilirubin photolability and the need for urgent treatment prior to hospital discharge There is currently not a single uniform test for HBR some hospitals test total serum bilirubin TSB levels laboratory based and others test transcutaneous bilirubin TcB point of care Significant shortcomings for both these tests are large blood sample drops of blood required for TSB and the inaccuracy and qualitative nature of TcB In addition other markers for hyperbilirubinemia including testing for glucose phosphate dehydrogenase G PD deficiency and bilirubin binding capacity are not part of routine newborn screening The few states that do offer newborn G PD screening utilize molecular screening the results of which are reported too late to impact the clinical course of any neonate with hyperbilirubinemia To minimize testing blood volume and provide a rapid test that is both sensitive and thorough we propose to develop a comprehensive hyperbilirubinemia testing panel using digital microfluidics Our device would revolutionize near patient newborn screening for hyperbilirubinemia by bringing the accuracy of the TSB test to the newborn nursery and combining with the point of care convenience of TcB using just a single drop of blood In addition our panel will provide the G PD status and bilirubin binding capacity as secondary markers for a more complete picture of hyperbilirubinemia status which if known earlier will change the clinical course and more importantly avoid re hospitalizations Jaundiced newborns are not discharged from the hospital until TSB results are known our rapid and comprehensive test will enable quicker time to result In Phase I we used a disposable digital microfluidic cartridge to demonstrate technical feasibility for an expanded bilirubin testing panel from whole blood that included TSB G PD albumin carboxyhemoglobin and bilirubin binding capacity We challenged our assays through key method comparisons using discarded whole blood samples The proposed Phase II project will refine assay development by multiplexing the key three assays TSB G PD deficiency and bilirubin binding capacity on a single cartridge developing an on board reagent storage method and fully implementing a device to be used near the patient Analytical validation along with a clinical evaluation at Duke University and Stanford University will demonstrate optimal system performance The final product will be a single platform for comprehensive hyperbilirubinemia testing using low blood volumes the target market will initially be hospitals and smaller clinics or pediatrician offices PROJECT NARRATIVE Multiplex Platform for Point of Care Newborn Screening of Hyperbilirubinemia PAR There is currently not a single uniform test for hyperbilirubinemia risk that is comprehensive rapid and sensitive Near patient testing is desirable in newborns so that immediate interventions can be started to prevent irreversible neurological toxicities To better assess risks of such damage specificity of risk and reasons for prolonged jaundice it is important to have an expanded panel to measure the spectrum of bilirubin load The proposed panel includes total serum bilirubin glucose phosphate dehydrogenase G PD deficiency and bilirubin binding capacity Availability of such a panel would lead to earlier intervention and reduce the incidence of severe neonatal hyperbilirubinemia and resultant risk of bilirubin induced neurological damage BIND