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Development of a Diagnostic Test for Eosinophilic Chronic Rhinosinusitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI179525-01
Agency Tracking Number: R41AI179525
Amount: $304,921.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-01
Award End Date (Contract End Date): 2025-08-31
Small Business Information
Salt Lake City, UT 84108-1228
United States
DUNS: 827444345
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (434) 249-3268
Business Contact
Phone: (801) 649-3999
Research Institution
SALT LAKE CITY, UT 84112-9049
United States

 Nonprofit College or University

PROJECT SUMMARYThe goal of this proposal is to optimize and clinically validate a new diagnostic test for eosinophilic chronic
rhinosinusitis (eCRS) at the point-of-care, improving the efficiency, value, and accessibility of personalized
medicine. eCRS affects up to 5 million Americans and is characterized by varying degrees of sinonasal and
peripheral eosinophilia, linked to treatment responsiveness in CRS. This predominantly type 2 inflammatory
disease leads to significant declines in patient quality of life and imposes an annual economic burden of greater
than $5.7B. Patients with eCRS typically fail the standard of care and turn to costly surgical intervention and
eosinophil-targeting biologic therapies to manage their disease. Moreover, these patients have significant
sinonasal symptoms despite aggressive medical management and are more likely to undergo revision sinus
surgery compared to other CRS cohorts. A definitive diagnosis of eCRS currently relies on meeting a sinonasal
tissue eosinophil count threshold obtained through surgical biopsy and pathologic examination, limiting
diagnoses to patients electing sinus surgery after medical treatment failure, with no potential to assess changes
in eosinophilia over time. Given the difficulty in controlling eCRS disease and that tissue eosinophilia is correlated
to treatment responsiveness, an accurate and reliable diagnosis of eCRS is critical, as it may have prognostic
and therapeutic implications for patients. GlycoMira is developing a minimally invasive, cost-effective, and timely
diagnostic solution based on a sinonasal swab and detection of an immunologic marker of tissue eosinophilia to
improve the treatment management and outcomes for patients with eCRS. A pilot study in patients demonstrated
that this test is capable of confirming a clinical diagnosis of eCRS within 25 minutes and with high sensitivity and
moderate specificity, suggesting that this test has a high potential to accurately predict a diagnosis of eCRS, as
well as serve as an objective tool by which to measure patient response to medical and surgical intervention. In
this proposal, the tissue eosinophil detection assay will be optimized and validated in patients using sinonasal
swabs that were specifically engineered to improve patient sampling precision and reliability, as well as assay
specificity for accurately confirming a diagnosis of eCRS in Aim 1. A prospective observational cohort study will
be performed to assess the clinical utility of this new test method to predict a diagnosis of eCRS at the point-of-
care in Aim 2. Test parameters will be optimized to minimize readout time and improve test specificity and
positive predictive value by comparing sinonasal swab results obtained from clinically diagnosed patients with
eCRS to those from patients with non-eCRS. Milestone achievements will result in the submission of a Phase II
proposal to expand test validation studies, obtain Premarket Notification 510(k) clearance, and conduct large-
scale manufacturing of eCRS test kits towards the commercialization of a point-of-care test for diagnosing and
monitoring eCRS.

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

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