TearLab's Discovery MMP-9 Test has failed to meet criteria for substantial equivalence based upon data and information submitted by the company in its 510(k) submission the US Food and Drug Administration (FDA).
TearLab’s Discovery platform is claimed to have been designed to enable eye care professionals in assessing biomarkers in human tears with nanoliter volume tear collection.
The lab-on-a-chip platform enables to measure tear proteins in a fully automated workflow that is consistent with the currently marketed TearLab Osmolarity System.
TearLab Osmolarity System being used by physicians in their practice. The MMP-9 test card will aid in the diagnosis of dry eye disease.
TearLab CEO Seph Jensen said: “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.”
In April this year, the company received a written feedback from FDA on the requirements for 510(k) clearance for its Discovery Platform and test card that can measure MMP-9, an inflammatory biomarker.
The company stated that the FDA-cleared predicate chosen for 510(k) substantial equivalence measures the qualitatively, but, the intended use of the Discovery MMP-9 test in the submission measures the biomarker quantitatively.
The US regulator has asked the company to provide additional information to establish correlation to the predicate.
TearLab develops and markets lab-on-a-chip technologies that allow eye care practitioners to enhance standard of care by objectively testing for disease markers in tears at the point-of-care.
The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is claimed to be the first assay developed for the TearLab Osmolarity System.