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Validation of a non invasive technology to measure bilirubin in newborns

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44HD090778-01
Agency Tracking Number: R44HD090778
Amount: $1,578,028.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PAR14-088
Timeline
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-29
Award End Date (Contract End Date): 2019-08-31
Small Business Information
3158 NE 81ST ST
Seattle, WA 98115-4746
United States
DUNS: 079606843
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHAEL CLARKE
 (206) 226-1910
 mike.clarke@gmail.com
Business Contact
 SHWETAK PATEL
Phone: (206) 543-3451
Email: shwetak@gmail.com
Research Institution
N/A
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 newborn infants from
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 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 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 andgt
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 different smartphones with the app installed to obtain sets of images from
phantoms representing various bilirubin levels over readings will be obtained Finally the usability of the
BiliCam app will be assessed in healthcare professionals who are the intended users for the initial
clearances for the technology A two year study period is planned
!Project narrative
BiliCam is a smartphone app based system that can be used to measure bilirubin in newborns that
could be used to provide better and less expensive healthcare In order for BiliCam to be used in
clinical settings clearance is needed from the Food and Drug Administration FDA The goal of the
proposed project is to conduct the studies need to support an application for FDA clearance for the
technology

* Information listed above is at the time of submission. *

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