This article is more than 5 years old. Information may no longer be current.

BioLight announces positive study results for TeaRx

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The TeaRx multi-assay test for evaluating tear components successfully completed its clinical study of both healthy subjects and patients suffering from dry eye syndrome, according to a press release from BioLight.

The study was conducted by Ora and consisted of 74 enrolled subjects in the U.S. Four established benchmark tests for the assessment of dry eye syndrome (DES) were used to evaluate the subjects in an effort to define and distinguish healthy subjects from those with different grades of DES. The tests have previously been used by the FDA for the regulatory approval processes of DES products, according to the press release.

The TeaRx assays were also used to evaluate the subjects. The results were used in combination with the subjects’ demographic data to provide a predictive statistical model that would determine the most appropriate combination of assays for a superior TeaRx multi-assay test.

TeaRx multi-assay test results, incorporating a combination of tear constituents originating from different locations in the eye, demonstrated sensitivity of 86%, specificity of 87% and a positive predictive value of 87%, the company reported.

Suzana Nahum Zilberberg, BioLight's CEO, commented in the release, "We are very excited about the results of this second U.S. clinical trial. TeaRx allows for an in-office, multi-assay testing process which, for the first time, has the potential of going beyond the binary diagnosis of DES by also identifying sub-populations among those who suffer from the syndrome.”