PROJECT SUMMARY
This Phase I STTR project is a collaboration between PGXL Technologies, LLC
(Company) and the University of Louisville Research Foundation (University) to develop an
innovative urine collection kit used to detect obstructive sleep apnea (OSA) in patients.
PGXL Technologies is developing a US-Patented, non-invasive urine-based assay for
obstructive sleep apnea (OSA) in children. The test is comprised of a panel of four protein
biomarkers detected in urine. OSA occurs in up to 3% of children and as much as 10% of the
pediatric orthodontic population including 7% in adults. OSA can lead to disturbed sleep,
neurobehavioral problems, neurocognitive impairments, and hypertension in children and
adults. Diagnosis is primarily limited to in-clinic sleep studies because patient history and
physical examinations are not adequately able to differentiate OSA from primary snoring (PS).
Polysomnography (PSG) tests are administered in sleep studies and are the gold standard for
diagnosis, but they are highly expensive, require an overnight stay in a supervised sleep clinic,
are difficult for children as well as adults, and do not meet the need for efficient screening for
OSA. There is only one at-home sleep diagnostic that has been cleared by the FDA for use in
children and it requires attachment of wires and sensors overnight, which is challenging to
implement with children. There is an unmet need for a rapid and sensitive test for OSA that can
be used for potential diagnosis, patient monitoring as they undergo treatment, and screening of
broader populations.
The Company is developing an immunoassay-based multiplex panel comprised of four
proteins (uromodulin, urocortin-3, orosomucoid-1, and kallikrein) associated with stress and
hypoxia detected in the urine of children with OSA. Preliminary published data indicates that this
set of markers provides a diagnostic sensitivity of 100% and specificity of 96.5% for OSA in
children. To confirm the efficacy of this test-panel with controlled studies we will require shipping
of urine samples to our testing facility after collection. Securing the integrity of the proteins
during shipping and storage is essential to our success. To address this challenge there is an
imminent need to develop a simple yet rigorous process for stabilizing the proteins during
specimen transport. In this Phase I STTR project we will use an innovative silica-based reagent
(BioCaRGOS) developed by our team and demonstrate that the reagent is compatible with our
immunoassay system and stabilizes the target proteins in urine under shipping conditions. This
proof-of-concept will enable the design of a rigorous urine collection kit required for our Phase II
clinical studies.
Completion of these goals will enable advancement toward a laboratory developed test
using a novel method for stabilizing and processing of urine samples needed for routine
collection and provide an approach towards FDA clearance of a multiplexed high throughput
assay for OSA. Commercialization of these products will enable delivery of a critically needed
rapid test that can be administered by PGXL Technologies or licensed to CLIA-certified clinical
labs. This will fill a need for rapid, sensitive, and cost-effective identification of OSA in children
and adults.