TearLab Corporation recently announced its next-generation in-vitro diagnostics testing platform — which gives ECPs the ability to assess multiple biomarkers in human tears with a single nanoliter volume tear collection — is in conformity with all the applicable provisions of In Vitro Diagnostic Medical Devices Directive 98/79 EC enabling CE Marking of the device.
According to TearLab, its lab-on-a-chip platform provides quantitative measurements of tear proteins in a fully automated workflow that is consistent with the current TearLab Osmolarity System. The CE Marking provides regulatory clearance for both the device and the initial next-generation test card, capable of measuring both osmolarity and an inflammation biomarker, which together will help identify patients expected to respond to dry eye disease (DED) therapies.
Additionally, TearLab reportedly plans to move quickly to seek CE Marking for a second protein biomarker that will, when combined with osmolarity and the first inflammation biomarker, comprise the initial commercial multiplex test card on the new platform.
Click here to read the full press release.
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Source: TearLab Corporation