Lab-on-a-chip for Neonatal Hyperbilirubinemia Screening

Period of Performance: 09/22/2009 - 03/31/2011

$189K

Phase 1 SBIR

Recipient Firm

Advanced Liquid Logic
Research Triangle Park, NC 27709
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): Despite aggressive public health campaigning and strict guidelines for diagnosis and treatment, the estimated incidence of severe hyperbilirubinemia (defined as serum bilirubin levels greater than 99th percentile) is 1:70. Severe hyperbilirubinemia can cause a spectrum of neurologic dysfunction of which kernicterus is the most concerning. Kernicterus manifests as a life-long movement disorder with occulomotor and auditory dysfunction. The subcommittee on Hyperbilirubinemia of the American Academy of Pediatrics (AAP) has proposed guidelines to reduce the frequency of severe neonatal hyperbilirubinemia and bilirubin encephalopathy. These include the recommendation to measure total serum bilirubin level or cutaneous bilirubin level of all infants with jaundice in the first 24 hours of life. The committee also identified the need for screening for hereditary causes such as G6PD deficiency and congenital hypothyroidism, which if present can change the treatment completely. Early identification and initiation of treatment can prevent acute bilirubin encephalopathy and kernicterus. Currently testing for hyperbilirubinemia is often available at the point of care, but results are usually returned after patient discharge. Tests for G6PD and CH are usually done only if the patient does not respond to therapy. In this proposal, we describe a new technology that has the potential to dramatically simplify the testing process and expedite the availability of test results. Time is of the essence in diagnosis of these newborn conditions as significant brain injury can be prevented by prompt treatment. This new technology will require minimal resources, will be low cost, and will be suitable for use in hospitals, outpatient clinics, and rural communities. Availability of portable and multiplex devices for on-site screening will enable rapid diagnosis of at-risk infants. Development of a device that could perform multiple assays for common newborn disorders at the point-of-care with rapid turnaround is an initial step in the development of multiplex testing with an on-site portable device. PUBLIC HEALTH RELEVANCE: Advanced Liquid Logic, Inc. is developing a lab-on-a-chip on its proprietary digital (droplet-based) microfluidic platform for clinical diagnostics. The proposed project aims to demonstrate a near-patient platform for screening neonates with very high levels of bilirubin (hyperbilirubinemia). The device would be greatly useful in rapid identification and enable early treatment.