TeaRx™ – A Dry-Eye Diagnostic Test
DiagnosTear Ltd. develops an innovative Dry-Eye diagnostic test namely TeaRxTM
TeaRxTM, a diagnostic solution that provides a multi-parameter, objective, rapid, simple, semi-quantitative analysis of tear film to identify one or more underlying causes of DES. We believe TeaRxTM has the potential to be both a clinically valuable point-of-care test as well as a companion diagnostic test that addresses the need for rapid testing and personalized medicine. We expect TeaRx to be a cost-effective, easy-to-use and objective solution that will allow eye-care professionals to diagnose and treat patients who suffer from symptoms of DES, including those who may otherwise be undiagnosed or unidentified.
DES is a common disorder of the ocular surface in which the eye produces insufficient tears or tears with abnormal composition. In its mild to moderate forms, DES may cause pain and discomfort and can impact vision quality. In its most severe forms, DES can lead to permanent vision loss. DES affects approximately 337 million people worldwide, approximately 40 million of whom are in the United States, and dry eye-related symptoms account for one third from all visits to eye doctors in the United States.
There is a need for objective, actionable information that physicians can use to understand the root cause of patients complaints, enable personalized treatment, determine the effectiveness of the selected therapy and enable effective follow-up
The device is a cost-effective solution, rapid and easy to use diagnostic test that will be able to identify the origin of the condition for targeted therapy and can be used by any health care professional.
TeaRxTM could act as a combined solution of a diagnostic test with a specified therapy or as a standalone kit.
Positive Clinical Test Results
In a 200 DES patients study, the TeaRx demonstrated strong correlation with the widely used benchmark tests (Schirmer, BUT, Staining, Questionnaire).
In a 74 patients study, the TeaRx showed a 86% sensitivity and 87% specificity in distinguishing between DES patients and healthy subjects.
A recent study enrolled 82 subjects (41 healthy, 41 with DES) reconfirmed planned timeline in H2/2018 for CE approval and FDA pivotal trial