SAN DIEGO, March 06, 2017 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) today announced that its next-generation in-vitro diagnostics testing platform is in conformity with all the applicable provisions of In Vitro Diagnostic Medical Devices Directive 98/79 EC enabling CE Marking of the device. CE Marking provides 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 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.
“TearLab’s next generation platform represents a breakthrough in providing improved ability to diagnose ocular diseases. 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,” said Eric Donnenfeld, MD, Clinical Professor of Ophthalmology New York University Medical Center. “We have used the current TearLab Osmolarity System to aid in the identification of DED patients in our practice and look forward to leveraging the capabilities of the new platform to improve our diagnostic accuracy and enhance the level of patient care we can deliver.”
Seph Jensen, CEO of TearLab Corporation added, “CE Marking of our next-generation platform is a groundbreaking achievement for TearLab. This platform offers a safe, convenient and quantitative method to diagnose diseases using human tears. This platform will allow us to iterate various disposable tests aimed at diagnosing both eye related and other systemic diseases without the need to replace and develop hardware for each new test.”
The Company also announced that it will move to quickly 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. The Company then plans 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 U.S. Food and Drug Administration, which is expected in the third quarter 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.
About TearLab Corporation
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. TearLab Corporation's common shares trade on the NASDAQ Capital Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the symbol 'TLB'.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others, statements concerning the market for dry eye patients, the potential success in developing and commercializing the next generation testing system and the TearLab Osmolarity System, the ability to file and secure additional CE Marking and U.S. Food and Drug Administration approval for the next generation commercial test card and testing device. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are based on management’s current, preliminary expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 9, 2016, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, filed with the SEC on November 9, 2016. We do not undertake to update any forward-looking statements except as required by law.
The Ruth Group Lee Roth