DiagnosTear Announces Clinical Study with AlyaTec to Advance Analytical Validation and FDA Submission Pathway of TeaRx(TM) Red Eye Diagnostic Test

Executive Summary

• DiagnosTear Technologies announced a collaboration with CRO AlyaTec to conduct a clinical study of its TeaRx™ Red Eye diagnostic test.
• The study will enroll up to 30 allergy patients, collect tear samples before and after provocation, and compare IgE levels to the TeaRx™ assay to validate tear‑IgE as a biomarker for allergic conjunctivitis.
• Successful validation is intended to strengthen DiagnosTear’s FDA submission pathway and support future global commercialization of the test.

Key Details

• Collaboration Partner: AlyaTec, a French contract research organization specializing in allergy and environmental disease studies.
• Study Objective: Validate and analytically characterize total tear IgE as a biomarker for allergic conjunctivitis and assess performance of TeaRx™ Red Eye against independent quantitative IgE testing.
• Patient Enrollment: Up to 30 documented allergy patients.
• Timeline: Site approvals and setup – ~3 months; patient recruitment – 2‑3 months thereafter.
• Assay Focus: TeaRx™ Red Eye is a rapid, multi‑biomarker point‑of‑care test designed to differentiate adenoviral conjunctivitis, herpetic keratitis, and allergic conjunctivitis within minutes.
• Regulatory Impact: Data from the study will be used to finalize validation, reinforce the scientific case for the diagnostic panel, and support FDA clearance submissions.
• Future Plans: Pending successful results, DiagnosTear intends to launch additional clinical trials aimed at full FDA clearance and worldwide market rollout.

Notable Quotes

“This collaboration with AlyaTec represents a strong accelerator for our Red Eye program,” said Dr. Shimon Gross, CEO of DiagnosTear.
“Our goal is to deliver a test that gives clinicians immediate clarity, improves patient management, and reduces unnecessary treatments.”