# A Device for Measuring Blood Concentrations of Unbound Bilirubin in Neonates

> **NIH NIH R44** · FLUORESPROBE SCIENCES, LLC · 2020 · $444,754

## Abstract

Project Summary/Abstract
 The overall goal of this project is to complete development of the unbound bilirubin (Bf) assay system for
assessing the risk of neonatal bilirubin encephalopathy (kernicterus). This includes establishing a manufacturing
process for the components of the assay (reagents, disposable test cartridge, reader), transferring the
manufacturing process to a contract manufacturer, instituting FDA quality systems and obtaining FDA 510(k)
clearance. This test, the UBCheck assay, was developed with the assistance of a grant from NICHD
(5R44HD080412).
 The reason for developing a test for Bf is that it is clear from numerous studies over the past 40 years
that Bf is a much more reliable indicator of the risk of bilirubin encephalopathy (kernicterus) than total bilirubin
(TSB)- the current standard of care. Almost all studies that have demonstrated the superiority of Bf to TSB have
used an assay based upon peroxidase oxidation of bilirubin. The FDA cleared the Arrows UB Analyzer (Japan)
test for Bf in 1987 which is based on the peroxidase assay. However, the Arrows device has not been adopted
for use, except in Japan, for a variety of technical issues.
 The assay we developed (UBCheck) solves the technical/scientific issues that prevented widespread
adoption of the Arrows method. The assay, is complete within~ 1 minute and requires 5 µL of plasma or whole
blood (CVs ≤ 8%). There is confidence that our assay will be commercialized because we have executed a
license agreement with Masimo, a publicly traded medical device company with a large sales force focused on
hospital intensive care units, including neonatal units. The license requires that Fluoresprobe complete
development, obtain FDA approval and initiate manufacturing through a contract manufacturer. If those
milestones are achieved Masimo will be obligated to market and distribute the test worldwide.
Aim 1: We will develop the scaled-up manufacturing processes and transfer this to the contract
manufacturer
 Aim 2: With the CRO DOCRO we will perform the analytical studies required for FDA submission
and seek 510(k) FDA clearance for the UBCheck assay

## Key facts

- **NIH application ID:** 9954112
- **Project number:** 5R44HD080412-06
- **Recipient organization:** FLUORESPROBE SCIENCES, LLC
- **Principal Investigator:** Alan Marc Kleinfeld
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $444,754
- **Award type:** 5
- **Project period:** 2014-09-23 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9954112

## Citation

> US National Institutes of Health, RePORTER application 9954112, A Device for Measuring Blood Concentrations of Unbound Bilirubin in Neonates (5R44HD080412-06). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9954112. Licensed CC0.

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