NEW YORK (360Dx) – TearLab today announced it has met conditions for CE marking of its TearLab Discovery system, paving the way for it to market the device in the European Union and to member countries of the European Free Trade Association.
The lab-on-a chip platform allows for the evaluation of multiple biomarkers in human tears with a single nanoliter volume tear collection. It quantitatively measures tear proteins in an automated workflow consistent with the current TearLab Osmolarity system, the firm said, adding the CE mark expands regulatory clearance beyond an earlier device to include the first commercial test card.
The card measures three biomarkers, including osmolarity and the inflammatory biomarkers MMP-9 and IL-1Ra. Combined they will aid professionals diagnose dry eye disease and identify patients who may respond to therapies for the condition.
TearLab said it plans to build a robust clinical data package, as well as secure feedback from key opinion leaders, in support of a 510(k) submission to the US Food and Drug Administration, expected in the second half of 2017.
"The ability to measure osmolarity and two inflammatory biomarkers in one quick test should help doctors differentially diagnose and select the right treatment for each patient," TearLab CEO Seph Jensen said in a statement.