# An Innovative Unbound Bilirubin Assay to Identify Bilirubin-Induced Neurological Dysfunction (BIND) Risk as Part of a Comprehensive and Novel Point-of-Care Newborn Screening Panel

> **NIH NIH R44** · BAEBIES, INC. · 2020 · $767,530

## Abstract

ABSTRACT
 An Innovative Unbound Bilirubin Assay to Identify Bilirubin-Induced Neurological Dysfunction (BIND) Risk as
 Part of a Comprehensive and Novel Point-of-Care Newborn Screening Panel
 (Fast Track SBIR)
Neonatal hyperbilirubinemia, or elevated bilirubin, occurs in over 80% of newborns and results in jaundice.
When treated promptly, hyperbilirubinemia is usually benign but if left untreated elevated bilirubin levels can
result in bilirubin toxicity and severe neurological dysfunction. Despite routine newborn screening for elevated
total serum bilirubin (TSB) levels as an indicator of hyperbilirubinemia, underlying causes such as glucose-6-
phosphate dehydrogenase (G6PD) deficiency and the risk for bilirubin induced neurological dysfunction (BIND)
remain an unaddressed public health concern. While many enzyme dysfunction disorders are screened in U.S.
state public health laboratories as part of the normal dried-blood spot newborn screening process, G6PD's
relatively high-incidence and its association with neonatal jaundice make it uniquely suited to be both screened
and severity assessed at the point-of-birth. With existing funding, we are developing FINDER, a small footprint
digital microfluidic device for near-patient, medium risk assessment testing in a hospital; the launch panel will
assess for hyperbilirubinemia risk by measuring TSB, albumin, direct bilirubin and G6PD deficiency. We expect
to submit the FINDER device and launch panel of assays for FDA review within the next year.
This Fast-Track project will focus on two key factors that are missing from FINDER for comprehensive G6PD
screening and BIND risk assessment: 1) the presence of the challenging, but vitally important, unbound
bilirubin (UB) assay; and 2) a digital architecture to support the simplicity requirements of CLIA-waived
screening and the necessity to integrate screening results to an eventual large-scale database. The ability to
measure unbound bilirubin will allow clinicians to have a more complete understanding of bilirubin binding and
thus the risk for bilirubin toxicity; neurotoxicity (including BIND and kernicterus) result from poor bilirubin
binding in plasma. Phase I aims will focus on assay development and preliminary digital architecture
implementation while Phase II aims will center on a method comparison of the unbound bilirubin assay to a
predicate device. The resulting assay panel and platform will be field tested at 4 clinical sites with a high
percentage of G6PD deficient patients.
This product has the potential to be a paradigm shift in the U.S. for near-patient, universal biochemical
screening, normally delegated to state public health laboratories, and can be used in the hospital or physician's
office to identify newborns who might need to be admitted to the hospital for prompt treatment. Despite its
prevalence and critical role in neonatal hyperbilirubinemia, G6PD enzyme deficiency is rarely screened in the
U.S.; hemolysis “crisis” triggers, inadeq...

## Key facts

- **NIH application ID:** 10026460
- **Project number:** 4R44HL146016-02
- **Recipient organization:** BAEBIES, INC.
- **Principal Investigator:** Jennifer Elderbroom
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $767,530
- **Award type:** 4N
- **Project period:** 2019-07-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10026460

## Citation

> US National Institutes of Health, RePORTER application 10026460, An Innovative Unbound Bilirubin Assay to Identify Bilirubin-Induced Neurological Dysfunction (BIND) Risk as Part of a Comprehensive and Novel Point-of-Care Newborn Screening Panel (4R44HL146016-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10026460. Licensed CC0.

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