BioLight Life Sciences Investments (Tel Aviv, Israel), which invests in, manages, and commercializes biomedical innovations in ophthalmology and cancer diagnostics, has completed a U.S. clinical study conducted by Ora (Andover, MA) that compared widely used benchmark tests for dry eye syndrome with its TeaRx point-of-care diagnostic test, which is developed by DiagnosTear Ltd., one of BioLight's subsidiaries.
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In this prospective study consisting of approximately 200 subjects, widely used benchmark tests for dry eye were compared with the TeaRx diagnostic parameters, including Schirmer's test, Tear-Film Break-Up Time (TFBUT), staining of corneal and conjunctival epithelial cell damage, and patient questionnaires. The study analysis was based on testing the sample extremes, quartiles 1 and 4, representing those enrolled subjects with largest differences for each metric.
This approach resulted in positive statistical correlations that showed many of the predicted trends and correlations between the widely used benchmark tests and the TeaRx diagnostic parameters tests which measure tear film components.
The positive correlation that was identified between certain TeaRx diagnostic parameters and subjective testing standards that are widely used today indicates a unique ability for improving the dry eye syndrome diagnosis by objective quantification of measures over subjective evaluation.
The company plans to initiate a second clinical trial in order to assess the effectiveness of the tests in tears of healthy subjects as well as patients with severe dry eye syndrome, based on the FDA definitions as were used in previous FDA regulatory approval processes for other dry eye syndrome diagnostic products. The trial results are expected in Q2 2015 and should enable the company to specifically define the combination of parameters to be part of a commercially available diagnostic kit and then initiate the regulatory processes for the kit. Assuming the completion of a successful development and regulatory process, BioLight expects to obtain regulatory approvals and launch the multi-parameter test kit in 2016.
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