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September 10, 2026 8:30 AM EDT | Source: DiagnosTear Technologies Inc.
Vancouver, British Columbia--(Newsfile Corp. - September 10, 2026) - DiagnosTear Technologies Inc. (CSE: DTR) (FSE: X8F) ("DiagnosTear" or the "Company"), an innovator in point-of-care ocular diagnostics, is pleased to announce positive final results from its clinical study conducted with AlyaTec for TeaRx™ Red Eye further to the Company's press releases dated December 2, 2025, February 26, 2026, and July 9, 2026.
The final results were obtained and analysed from 93 tear samples originating from 31 subjects tested before and after ocular provocation with feline allergen. Each tear sample was tested using both the TeaRx™ Red Eye product developed by the Company and a quantitative reference Enzyme Immunoassay (ELISA) for human Immunoglobulin E (IgE).
For the analysis, an ELISA IgE concentration of ≥100 ng/mL was defined as positive , while concentrations <100 ng/mL were defined as negative . Comparison of TeaRx™ Red Eye performance with the quantitative ELISA reference method demonstrated 89% sensitivity and 83.3% specificity .
TeaRx™ Red Eye is being developed as a rapid, multi-biomarker diagnostic test designed to aid in the differentiation between Adenoviral conjunctivitis, Herpetic keratitis, and Allergic conjunctivitis at the point of care. The ability to identify ocular allergy through tear-based total IgE testing could meaningfully improve clinical decision-making and support more precise management of red eye conditions.
Dr. Shimon Gross, CEO of DiagnosTear, commented:
"These final results represent an important milestone for our TeaRx™ Red Eye program. Across 93 samples, TeaRx™ Red Eye demonstrated strong diagnostic performance compared with quantitative ELISA, including 89% sensitivity, 83.3% specificity and an AUC of 0.872 in a ROC analysis. These results are particularly important as we advance our FDA Pre-Submission process for TeaRx™ Red Eye (for further details, see press release dated September 3, 2026). The results demonstrated in this clinical study increase our confidence in the test's ability to achieve the level of performance needed to support its intended clinical use. We believe these findings provide an important foundation as we engage with FDA and further define the clinical and analytical development program required to advance TeaRx™ Red Eye toward the U.S. market. "
Dr. Gross added: "Red eye is one of the most common presentations in eye care, yet differentiating between allergic, viral and other causes can be challenging based on clinical presentation alone. Our goal with TeaRx™ Red Eye is to provide clinicians with objective biomarker information at the point of care, helping to support faster and more informed diagnostic decisions. Completion of the AlyaTec study is another important step in advancing this program toward broader clinical validation and commercialization."
DiagnosTear Technologies Inc. is an innovatorin rapid, point-of-care diagnostics for ocular diseases. The Company develops multi-parametric tests that provide fast, clinically actionable insights based on tear fluid analysis. DiagnosTear's mission is to transform ophthalmic care with accessible diagnostics that support precise, data-driven decision making.
AlyaTec is a French Contract Research Organization (CRO) specializing in allergy research. Known for its advanced clinical models and translational expertise, AlyaTec supports companies worldwide in advancing innovative diagnostic and therapeutic solutions.
Dr. Shimon Gross Chief Executive Officer DiagnosTear Technologies Inc. +972-52-3408550 shimon@diagnostear.com www.diagnostear.com
THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED AND DOES NOT ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE, NOR HAS OR DOES THE CSE'S REGULATION SERVICES PROVIDER.
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities legislation. Forward-looking statements may be identified by words such as "anticipate," "believe," "expect," "intend," "may," "plan," "potential," "should," "will" and similar expressions, or statements concerning events or conditions that may occur in the future.
Forward-looking statements in this press release include, without limitation, statements regarding the potential clinical utility of TeaRx™ Red Eye, including its ability to aid in the differentiation between adenoviral conjunctivitis, herpetic keratitis and allergic conjunctivitis at the point of care and to improve clinical decision-making; the significance of the final results of the AlyaTec clinical study and their relevance to the Company's regulatory and development strategy; the Company's FDA Pre-Submission process and its anticipated engagement with the FDA; the ability of TeaRx™ Red Eye to achieve the level of performance required to support its intended clinical use; the further definition of the clinical and analytical development program for TeaRx™ Red Eye; the advancement of TeaRx™ Red Eye toward broader clinical validation, regulatory clearance and commercialization, including in the U.S. market; and the Company's mission and business strategy generally.
Forward-looking statements are based on the opinions, expectations and assumptions of management as of the date of this press release, including assumptions that the results of the AlyaTec study will be indicative of the performance of TeaRx™ Red Eye in future studies and in its intended clinical use; that the Company will be able to design, fund and complete the additional clinical and analytical studies that may be required; that the Company's engagement with the FDA will proceed on anticipated timelines and that the FDA will not require substantially different or more extensive data than currently anticipated; that the Company will be able to obtain financing on acceptable terms when needed; that the Company will continue to have access to third-party contract research organizations, suppliers and other partners; and that there will be continued clinical demand for point-of-care ocular diagnostics.
Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those expressed or implied, including the risk that the results of the AlyaTec study, which was based on a limited number of samples and subjects and utilized an ocular allergen provocation model, may not be replicated in larger or more diverse patient populations or in real-world clinical settings; the risk that the FDA or other regulatory authorities may require additional studies, different study designs or performance thresholds, or may decline to clear or approve TeaRx™ Red Eye; uncertainty regarding the regulatory classification and pathway for TeaRx™ Red Eye; technical and development risks associated with a multi-biomarker point-of-care test; the Company's need for additional financing and the risk that such financing may not be available on acceptable terms or at all; the Company's reliance on third parties, including contract research organizations, for the conduct of its studies; competition from existing and emerging diagnostic technologies; market acceptance and reimbursement risks; intellectual property risks; general economic conditions; geopolitical risks; and other risks described in the Company's public filings available on SEDAR+.
TeaRx™ Red Eye is an investigational device and has not been cleared or approved by the U.S. Food and Drug Administration, Health Canada or any other regulatory authority.
Except as required by applicable securities laws, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/313747
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