FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence

TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence.

The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter volume tear collection. The MMP-9 test is designed to aid in the diagnosis of dry eye disease, the company added.

“We understand the FDA’s position and are encouraged by the clear guidance they have provided. We are working diligently to compile the additional information necessary to achieve a 510(k) clearance. We maintain our belief that TearLab Discovery represents a breakthrough technology capable of providing clinically efficient, cost-effective, point-of-care diagnostic tests. We will continue working with the FDA to provide additional data for a new MMP-9 submission and remain committed to securing its 510(k) clearance,” CEO Seph Jensen said in an SEC filing.

In April, TearLab said that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card.

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