DiagnosTear is a leading ophthalmic company developing and commercializing disruptive diagnostic solutions for better management of eye diseases. DiagnosTear’s TeaRx™ technology is a diagnostic platform intended for Point-of-Care Testing (POCT) of ophthalmic pathologies through multi-parameter composition analysis of the tear fluid.
TeaRx™ technology is based on a minute sample of tear fluid taken with a unique, single-use, microfluidic tear collection device, followed by a semi-quantitative multi-parameter immunoassay, visual or digital readout and cloud-based analysis providing intuitive interpretation of the results. The whole procedure takes less than 10 minutes.
The first CE-IVD approved test based on the TeaRx™ platform is intended for the identification and monitoring of Dry Eye Syndrome (TeaRx™ DES).
Analysis of the results of a large clinical trial onducted in LV Prasad Eye Institute (LVPEI, Hyderabad, India) performed on ~500 subjects defined as eligible DES patients and ~100 subjects that were defined as eligible healthy controls, indicated the following outcomes:
(1) TeaRxTM differentiated between severe DES subjects (Grades 3-4) vs. non-severe patients and healthy controls (Grades 0-2) at sensitivity, specificity, and accuracy levels of 80.6%, 66.7% and 68%, respectively.
(2) TeaRxTM differentiated between DES subjects at all severity levels (Grades 1-4) vs. healthy controls at sensitivity, specificity, and accuracy levels of 72%, 63% and 70.1%, respectively.
(3) TeaRxTM identified the presence of severe Meibomian Gland Disfunction (MGD, the most common underlying cause of evaporative DES, as classified by meibography grades 3-4) vs. Non-MGD (meibography grade 0), within the group of eligible DES patients, at sensitivity, specificity, and accuracy levels of 80.6%, 61.3% and 76%, respectively.
(4) Analysis of the data from 35 eligible DES patients which were prescribed with topical Cyclosporin A (CysA) therapy at baseline, and for whom independent, objective data was gathered 3 and/or 6 months after initiation of therapy, revealed that the product is capable to predict at baseline responders vs. non-responders at sensitivity, specificity, and accuracy levels of 94%, 63% and 77%, respectively, indicating the potential of the product to identify non-responders and further increase the ability to select patients with the best chance to respond for therapy.
To the best knowledge of DiagnosTear, these results are based on the widest and most diverse cohort of subjects ever studied for diagnostics of DES.
Beyond DES, DiagnosTear is developing innovative tests based on the TeaRx™ platform for additional ophthalmic indications. Among others, DiagnosTear’s pipeline tests include TeaRx™ Red Eye; The first test of its kind for differential assessment of adenoviral conjunctivitis, Herpetic Keratitis and Allergic conjunctivitis.