TearLab Announces European Regulatory Clearance for Next-Generation TearLab Discovery System

Source: TearLab

Friday, July 21, 2017 | CE Mark Approval , Dry Eye , TearLab Corp.


TearLab announced that the commercial version of its next-generation in-vitro diagnostics testing platform, the TearLab Discovery System, has received CE Marking, providing clearance in the European Union (EU) and European Free Trade Association (EFTA) member countries.

For the first time, the TearLab next-generation platform offers eye care professionals the ability to assess multiple biomarkers in human tears with a single nanoliter volume tear collection. The 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, which many physicians have incorporated into their practice. This CE Marking expands regulatory clearance beyond the previously-cleared Discovery device to include the first commercial test card. This test card is capable of measuring three biomarkers, including osmolarity and two inflammatory biomarkers, MMP-9 and IL-1Ra, which together will aid in the diagnosis of dry eye disease and identify patients expected to respond to targeted dry eye disease therapies.

"TearLab's next generation platform, TearLab Discovery, is truly a groundbreaking platform and represents the first entry in the point-of-care molecular diagnostic space for eye care. The platform will have the ability to quantitatively measure multiple tear biomarkers in one quick test and will truly revolutionize how eye care practitioners practice medicine," Arthur Cummings, MD, Consultant Eye Surgeon at the Wellington Eye Clinic and Consultant Ophthalmologist and Head of the Department of Ophthalmology at the Beacon Hospital in Ireland, said in a company news release. "This new diagnostic platform will streamline the testing process and serve as a platform to help guide the diagnosis and treatment selection for numerous ocular conditions."

"The CE mark for the TearLab Discovery platform represents a breakthrough in ophthalmic diagnostic technology and will help usher in a new era in eye care that leverages the power of molecular diagnostics at the point of care, which has long been standard of care in other medical specialties to both diagnose diseases and guide treatment," Seph Jensen, CEO of TearLab Corporation said in the news release. "When it comes to dry eye disease, symptoms do not always correlate to the disease and the impact on patients is broad - from eye discomfort to surgical outcomes to contact lens wear time. 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. We look forward to introducing TearLab Discovery at the European Society of Cataract and Refractive Surgeons in October 2017."

The company plans to initially use the regulatory clearance for TearLab Discovery to build a robust clinical data package and secure valuable feedback from global key opinion leaders in support of a 510(k) submission to the FDA, which is expected in the second half of 2017.

To date, TearLab has placed over 5,000 devices worldwide and had more than 8 million tests performed on the TearLab Osmolarity System globally since the commercial launch in 2012.


Comments

You must be logged in to leave a comment.