FDA Grants TearLab(R) Osmolarity System CLIA Waiver Categorization
SAN DIEGO, Dec 5, 2011 (GlobeNewswire via COMTEX) -- TearLab Corporation TEAR +69.36% CA:TLB -0.71% ("TearLab" or the "Company") announced today that it is in receipt of a communication from the U.S. Food and Drug Administration ("FDA") indicating that, based on a supervisory review of the Company's appeal, the Agency has granted its petition for a waiver under CLlA for the TearLab(R) Osmolarity System. Upon the Company's submission of labeling acceptable to the Agency, the CLIA waiver will be issued.
"This marks the achievement of our third and final major milestone," commented Elias Vamvakas, TearLab's Chief Executive Officer.
Mr. Vamvakas continued, "We believe that in order for the TearLab Osmolarity System to become widely adopted, it is essential that it be accessible at the point-of-care. Now, with the CLIA waiver obstacle overcome, this groundbreaking test is free to start growing to its potential."
About The TearLab Osmolarity System
The TearLab Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear Osmolarity. The TearLab Osmolarity System eliminates the challenges that previously prevented point-of-care Osmolarity testing. The TearLab(TM) System can produce a sample-to-answer result in less than 30 seconds.
About Dry Eye Disease
DED is a common condition in which the eye does not produce enough tears to keep the surface of the eye sufficiently lubricated. It affects approximately 40 million people in the U.S. and 100 million people worldwide.
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(TM) Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab(TM) Osmolarity System. Headquartered in San Diego, CA, 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'.
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