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A sleep biomarker test for management of ADHD

Award Information
Agency: Department of Health and Human Services
Branch: Centers for Disease Control and Prevention
Contract: 1R43DD001299-01A1
Agency Tracking Number: R43DD001299
Amount: $309,250.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: CDC
Solicitation Number: PA-21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-30
Award End Date (Contract End Date): 2023-09-29
Small Business Information
1817 Brownsboro Road
Louisville, KY 40206
United States
DUNS: 012986391
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (502) 822-3372
Business Contact
 Christopher Thomas Burns
Phone: (502) 822-3372
Research Institution

Project Summary/Abstract: PGXL Technologies is developing the Uromarker test for rapid screening of obstructive sleep apnea (OSA) and sleep disordered breathing that may contribute to attention deficit hyperactivity disorder (ADHD) in children. ADHD is the most common behavioral disorder in children and has significant effects on short- and long-term outcomes including poor education performance, increased risk of substance abuse, and reduced occupational success, amongst others. Recent research has identified that as many as 70% of patients with ADHD have mild to severe sleep problems. Daytime behavioral symptoms seen in OSA and sleep disordered breathing share many similarities with the clinical manifestations of ADHD including impaired attention regulation, overactivity, mood lability, behavior problems, poor impulse control, and prolonged reaction time. The association between sleep problems and ADHD are likely complex and multidirectional, but there is increasing evidence that demonstrates treatment of OSA may decrease or even eliminate ADHD symptoms. Treatment of OSA with standard approaches such as adenotonsillectomy has been associated with decreased ADHD symptoms up to a year after treatment. Identification of patients with OSA in the context of ADHD will therefore aid in determining the more appropriate first step in the multi-modal approach to treatment of ADHD. Unfortunately, OSA and sleep disturbances in children are only diagnosed with polysomnography tests that are expensive, require overnight sleep studies, and often have long wait times for patients to receive the test. These tests are not routinely considered in ADHD work-up. The development of a rapid screening test for OSA and sleep disordered breathing will provide significant clinical value in the diagnostic clarification of ADHD. To address this need, PGXL Technologies is developing the Uromarker test, a rapid multiplexed test that uses 4 biomarkers present in urine to efficiently and cost-effectively identify OSA or sleep disordered breathing in children. These biomarkers, when used in combination, have previously been shown to have 100% sensitivity and 96.5% specificity for detection of OSA in children compared to healthy primary snoring controls. PGXL Technologies has the patent to these biomarkers and, in this Phase I proposal, PGXL will develop these biomarkers into a multiplexed, high-throughput assay using all 4 biomarkers and will analytically characterize the assay. The stability of the biomarkers in urine will also be demonstrated to show feasibility for a mail-in urine collection kit that will enable identification of OSA and sleep disordered breathing in children towards supporting ADHD diagnosis.

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

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