Dr. Shimon Gross reports

DIAGNOSTEAR ANNOUNCES POSITIVE FINAL RESULTS FROM CLINICAL STUDY DEMONSTRATING STRONG DIAGNOSTIC PERFORMANCE OF TEARX RED EYE FOR DETECTING TOTAL TEAR IGE AS A BIOMARKER FOR ALLERGIC CONJUNCTIVITIS

Diagnostear Technologies Inc. has released positive final results from its clinical study conducted with AlyaTec for TeaRx red eye further to the company's press releases dated Dec. 2, 2025, Feb. 26, 2026, and July 9, 2026.

The final results were obtained and analyzed 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.

For the analysis, an Elisa IgE concentration of "<b=100 ng/mL" was defined as positive while concentrations less than 100 nanograms per millilitre were defined as negative. Comparison of TeaRx red eye performance with the quantitative Elisa reference method demonstrated 89-per-cent sensitivity and 83.3-per-cent specificity.

TeaRx red eye is being developed as a rapid, multibiomarker 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, chief executive officer 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-per-cent sensitivity, 83.3-per-cent specificity and an AUC of 0.872 in a ROC analysis. These results are particularly important as we advance our FDA presubmission process for TeaRx red eye (for further details, see press release dated Sept. 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."

About Diagnostear Technologies Inc.

Diagnostear is an innovator in rapid, point-of-care diagnostics for ocular diseases. The company develops multiparametric 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.

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