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Near Patient Acute Kidney Injury Biomarker Analysis in Critically Ill Neonates

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44HD095225-02
Agency Tracking Number: R44HD095225
Amount: $1,516,029.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: HD18-028
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2018-12-01
Award End Date (Contract End Date): 2020-11-30
Small Business Information
615 DAVIS DR STE 800
Durham, NC 27709-4403
United States
DUNS: 079264306
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 724-8464
Business Contact
Phone: (919) 328-8354
Research Institution

Acute kidney injury (AKI) contributes to mortality and morbidity in critically ill neonates. The identification and
treatment of AKI are currently based on serum creatinine (sCr) levels; however, mounting evidence suggests
that sCr alone is insufficient to predict or prevent renal injury. sCr is in fact a measure of renal function, not
injury; sCr levels usually rise many hours after a renal injury, require a substantial magnitude of renal
dysfunction for detection and are diminished by fluid overload. Earlier detection of acute kidney injury,
coupled with improved characterization of the underlying etiology, may halt the progression to severe kidney
injury and improve long term damage. Measurement of sCr levels alone is insufficient to achieve this goal.
In response to RFA-18-028, this Fast-Track SBIR project aims to develop a novel microfluidic platform
(FINDER) for near patient, minimally invasive analyses of multiple AKI biomarkers in critically ill neonates.
The system will rapidly and simultaneously measure creatinine (Cr) plus four highly specific AKI biomarkers
(Neutrophil Gelatinase-Associated Lipocalin, NGAL; Cystatin C, CysC; Interleukin-18, IL-18; and Kidney
Injury Molecule-1, KIM-1) from a single (50 μl) drop of whole blood or urine. NGAL, CysC, IL-18 and KIM-1
each have different temporal profiles in relation to the duration of renal injury, and different magnitudes of
increase depending upon the precipitating insult (e.g. ischemic vs. toxic). The combined analysis of Cr with
these 4 biomarkers will provide critical information on the probable cause and temporal course of AKI and
may help delineate ongoing injury vs. previous damage. The automated FINDER AKI system can be used in
various distributed settings and will perform all assays in approximately 45 minutes. Results of the AKI
system will allow clinicians to: (a) diagnose AKI; (b) differentiate the etiology of AKI; and (c) predict clinical
outcomes of critically ill infants.
The Specific Aims for Phase I of this project include: 1) develop an automated panel of assays for five critical
AKI biomarkers (Cr, NGAL, CysC, IL-18 and KIM-1) on the single-use digital microfluidic cartridge; 2) perform
preliminary analytical validations of each individual assay; and 3) demonstrate preliminary feasibility of the
individual assays on discarded serum and urine samples. Upon successful completion of all assays on-
cartridge with high reliability and precision, the focus of Phase II will be to: 1) optimize reagent formulations
for on-cartridge drying and storage; 2) multiplex all assays to perform simultaneously on the same cartridge;
and 3) preliminary clinical validation of the complete AKI testing panel by method comparison to standard
reference tests. The final product will be commercializable for the rapid, efficient and accurate measurement
of AKI biomarkers in both urine and blood from critically ill newborns. We will seek FDA approval of the final
product, which will initially be marketed for use in pediatric patients in U.S. hospitals, with a potential future
market towards other patients who may benefit from the innovative features of the platform.

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

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