A physiologically stable ocular surface is a big determinant in cataract and refractive surgery outcomes, so TearLab Corp. is looking to build out its lab-on-a-chip platform to evaluate the ocular surface for additional biomarkers, CEO Seph Jensen told the panel on diagnostics and the premium channel at OIS@ASCRS 2016.
The TearLab Osmolarity Test, for diagnosing dry eye disease, is the first assay developed for the TearLab Osmolarity System. Now, TearLab is on course to develop a single test for multiple markers “so doctors can differentially diagnose, subtype disease, and direct therapy,” Jensen said.
“It’s gotten to the point where the ocular surface has really become a key rate-limiting step in achieving desired surgical outcomes,” he said. The TearLab tests can help preoperatively diagnose mild and moderate ocular surface disease, which can be easily missed yet still affect presurgical measurements, Jensen said, so having a tool that can diagnose earlier stages of disease can help drive the premium channel.
“When we add on the ability to multiplex combined with capabilities for EHR [electronic health record] integration, we will enhance TearLab’s position as the ideal solution at the point of care,” he said.
TearLab is “on pace” to obtain the CE mark by the end of this yearand file a 510(k) submission with the FDA in early 2017, Jensen said. “Our plans are to have one or two additional ‘inflammation-focused’ markers with our next test,” he added. “Our next system will be a true platform, with the capability to bring out new iterations every six months.”
In October 2013, Seph joined TearLab as the President and Chief Operating Officer and was promoted to Chief Executive Officer in January, 2016.