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TearLab Nabs CE Mark for Multiplex IVD Device, Dry Eye Assay

NEW YORK (360Dx) – San Diego-based TearLab announced yesterday that its next-generation, multiplex diagnostics platform for human tear samples has received CE marking as an in vitro diagnostic medical device.

The CE mark also covers an assay for response to dry eye disease therapy, which measures both osmolarity, a measure of solute concentration, and an inflammation biomarker.

"TearLab's next-generation platform represents a breakthrough in providing improved ability to diagnose ocular diseases," Eric Donnenfeld, a professor of clinical ophthalmology at New York University School of Medicine, said in a statement. "With its multiplexing capability, the system will enable us to measure not only osmolarity, but many other proteins and biomarkers in the tear film that reflect ocular surface conditions such as inflammation and allergy."

TearLab launched its current Osmolarity System in 2012 and has placed more than 5,000 instruments around the world, the firm said in a statement.

The new, automated, microfluidics-based platform will allow clinicians to quantitatively measure multiple biomarkers in tear samples at volumes as low as 1 nanoliter. The new platform will allow the firm to develop tests aimed at diagnosing both eye related and other systemic diseases on the same hardware, TearLab CEO Seph Jensen said.

TearLab plans to seek CE marking for a second protein biomarker assay before putting together a 510(k) submission to the US Food and Drug Administration in the third quarter of this year.