Validation of a non-invasive technology to measure bilirubin in newborns

Period of Performance: 09/29/2016 - 08/31/2017

$1.3MM

Phase 2 SBIR

Recipient Firm

Bilicam, LLC
SEATTLE, WA 98103
Principal Investigator

Abstract

Project Summary Neonatal jaundice, or hyperbilirubinemia, is an almost ubiquitous condition in newborn infants. In very rare circumstances, if an infant with signficant hyperbilirubinemia is undetected, kernicterus, a devastating and permanent neurologic condition, can develop. Still rare, but much more frequently, a neonate with significant jaundice is not identified until the bilirubin level is very high, necessitating complicated and expensive care to prevent bilirubin encephalopathy. Although the identification of infants with moderate hyperbilirubinemia, at levels that are easily treatable, is a central focus of neonatal care in the US, bilirubin levels typically peak after most neonates are discharged from the newborn nursery. There is currently a lack of accurate, inexpensive and widely available methodologies to screen discharged infants for jaundice, leaving a notable void in the overall system of care designed to prevent severe hyperbilirubinemia. Our group has developed a non- invasive technology, called BiliCam, to measure bilirubin in newborn infants. The technology is based on the analysis of digital images of newborn skin that are obtained with a smartphone app that we have developed. Based on this analysis a bilirubin estimate is calculated and displayed on the smartphone. A study to collect data do develop and finalize the algorithm converting data from the images into an estimate bilirubin level is currently in progress. To date, a racially and ethnically diverse sample of over 500 newborn infants from 7 sites across the United States have been enrolled in this study. The results are very promising; BiliCam provides estimates of bilirubin that are similar in accuracy to those achieved with a transcutaneous bilirubinometer, the predicate device. Data collection for the study will conclude in late 2016 and the algorithm will be finalized. In order to commercialize the technology, the developers have formed a private company, BiliCam, LLC. In a presubmission meeting with the Food and Drug Administration (FDA) the studies needed to be completed to support a 510(k) submission for initial clearance for Bilicam were described. The overall goal of the proposed project is to conduct these studies needed for obtaining FDA clearance. First, a clinical validation study will be conducted using BiliCam to estimate bilirubin levels in a diverse sample of > 200 newborns from three sites. The estimated bilirubin levels will be compared to the total serum bilirubin (TSB) level, the gold standard for clinical decision making, in the newborns. Second, the reproducibility of BiliCam results will be assessed using 10 different smartphones with the app installed to obtain sets of images from 3 phantoms representing various bilirubin levels; over 300 readings will be obtained. Finally, the usability of the BiliCam app will be assessed in 45 healthcare professionals who are the intended users for the initial clearances for the technology. A two-year study period is planned. !