Dr. Shimon Gross reports
DIAGNOSTEAR ANNOUNCES INTERIM CLINICAL STUDY RESULTS DEMONSTRATING EXCELLENT CORRELATION BETWEEN TEARX RED EYE AND QUANTITATIVE ELISA TESTING
Diagnostear Technologies Inc. has released positive interim analytical results from its continuing clinical study with AlyaTec for TeaRx red eye, further to the company's press releases dated Dec. 2, 2025, and Feb. 26, 2026.
Interim results were obtained and analyzed from 30 tear samples originating from the first 10 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 for human immunoglobulin E.
The results indicated excellent concordance between the two methods, with a correlation co-efficient (R2) greater than 0.95.
TeaRx red eye is being developed as a rapid, multibiomarker diagnostic test designed to differentiate among adenoviral conjunctivitis, herpetic keratitis and allergic conjunctivitis at the point of care. The company believes that the ability to rapidly identify active 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 interim results represent a significant advancement for our red eye program. Demonstrating excellent correlation between TeaRx red eye and a quantitative Elisa reference method provides further support for the analytical performance of our platform and strengthens the scientific foundation for our regulatory strategy."
Dr. Gross added: "We are encouraged by the high level of concordance observed in the first 30 tear samples tested. These results bring us closer to completing our analytical validation work and preparing for external, independent clinical trials designed to support our planned FDA 510(k) and CLIA waiver dual submission pathway."
The company expects to continue advancing the study with AlyaTec and will provide further updates as additional results become available.
About Diagnostear Technologies Inc.
Diagnostear is a global leader 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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