TearLab Corp. (TEAR) Reports Reimbursement for Osmolarity Test
SAN DIEGO, Oct. 8, 2010 (GLOBE NEWSWIRE) — TearLab Corporation (Nasdaq:TEAR – News) (TSX:TLB – News) announced today that the Committee for Medicare and Medicaid Services (CMS) has published their recommended payment determination for new test codes, which includes a proposed reimbursement rate for the TearLab Osmolarity Test, effective January 2011. The new Current Procedural Terminology (CPT) code that will apply to the TearLab Osmolarity test will be reimbursed by CMS at $24.01 per eye (National Limit). The actual CPT code will be published by the American Medical Association in December 2010.
Reimbursement by CMS will only be available for offices that have a Moderate Complex CLIA certificate until TearLab receives a CLIA Waiver categorization from the Food and Drug Administration (“FDA”). This waiver is currently under review by the FDA.
“With FDA approval last year, reimbursement marks the achievement of the second of our three key milestones for U.S. commercialization. We look forward to receiving our CLIA waiver certificate which will make it much simpler for individual doctors to provide the test for their patients,” commented Elias Vamvakas, TearLab’s Chief Executive Officer.
About The TearLab(TM) Osmolarity System
The TearLab(TM) 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(TM) 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. In its mild to moderate forms, it can impact vision and the ability to go about daily activities. In its more severe forms, DED can lead to permanent loss of vision.
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. 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’.
Forward-Looking Statements
This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about the Company. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Forms 10-K and 10-Q. We do not undertake to update any forward-looking statements.
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