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A Non invasive Assay for Obstructive Sleep Apnea

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL136220-01A1
Agency Tracking Number: R43HL136220
Amount: $224,628.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-07-10
Award End Date (Contract End Date): 2019-12-31
Small Business Information
Louisville, KY 40202-1246
United States
DUNS: 012986391
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (502) 852-1772
Business Contact
Phone: (502) 560-0321
Research Institution

Project Abstract
PGXL Technologies is developing novel urine based tests for detecting obstructive sleep apnea
OSA in children Obstructive sleep apnea OSA is a disorder giving rise to behavioral and learning
problems including misdiagnoses as attention deficit hyperactivity disorder ADHD in children The
CDC estimates the prevalence of pediatric OSA in the US at around million An added
complication is that the prevalence of primary snoring PS in children approaches thus
physicians are challenged in differentiating OSA from PS The gold standard test for diagnosing
OSA in children is polysomnography PSG but it is expensive up to $ per test involves an
overnight stay in a sleep laboratory and requires the placement of numerous sensors Parents are
often unwilling and children too uncooperative to endure a PSG test Take home sleep devices
allow patients to monitor their sleep patterns at home but are not available to children Thus a simple
and inexpensive urine test would fill an important and significant clinical need A preliminary study
comparing children diagnosed with OSA by polysomnography to children with PS revealed that the
peptide urocortin UCN a stress related biomarker was significantly increased in the urine of
children with OSA We have an issued US patent for the use of UCN as a biomarker for detecting
OSA and have also developed a mass spectrometry based assay and an immunoassay to measure
UCN To complete definitive studies validating the clinical sensitivity and specificity of using this
biomarker as a diagnostic for OSA it is necessary to have robust CLIA validated and standardized
assays not available today Upon completion of this Phase I project we will have optimized a mass
spectrometry assay to CLIA validated standards including establishing preliminary reference ranges
for UNC in urine Successful completion of this project will position our company for a Phase II
project to rigorously develop immunoassays and clinically validate the use of UCN as a biomarker
for detection of OSA This project is innovative in the application of a novel biomarker for detection of
OSA in children and in the use of novel extraction methods for measuring UCN Having robust
assays for detection of OSA is anticipated to have sustainable high impact in a significant and much
needed clinical problem of diagnosing sleep apnea in children This will provide a sustainable
commercialization path for PGXL Technologies to develop simple and inexpensive assays for clinical
laboratories by way of assay kits as well as point of care and other vitro diagnostics applications Project narrative
PGXL Technologies is developing a urine based test for detecting obstructive sleep apnea OSA in
children Obstructive sleep apnea is a common disorder affecting an estimated million children in
the USA Children are underdiagnosed for OSA due to the high cost and low compliance of
polysomnography tests which require an overnight stay at a sleep center Our technology once
clinically validated will allow physicians for the first time to screen children for OSA with a simple and
inexpensive urine test

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

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