SAN DIEGO, Jan. 11, 2011 (GLOBE NEWSWIRE) -- TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) ("TearLab" or the "Company") and COLA, a private, non-profit clinical laboratory education, consultation and accreditation organization, announced today that they have partnered to help make the TearLab™ Osmolarity System available in the U.S. at the point-of-care.
As previously announced, the TearLab™ Osmolarity test will be reimbursed by the Centers for Medicare and Medicaid Services (CMS), effective January 1, 2011. Reimbursement will only be available, however, for offices that have a Moderate Complexity CLIA certificate until such time that TearLab receives a CLIA Waiver categorization from the U.S. Food and Drug Administration ("FDA"). This waiver is currently under review by the FDA.
In order to help make the groundbreaking TearLab Osmolarity™ test available through some of the estimated 50,000 U.S. eye care practitioners that do not currently operate with Moderate Complexity CLIA certifications, the Company has partnered with COLA to provide interested doctors with a customized package of education, consulting and accreditation services designed to allow them to meet CLIA standards and qualify as a Laboratory Director for Moderate Complexity testing in their field. As such, they will be able to supervise up to five individual doctor locations where the TearLab™ Osmolarity test can be performed and reimbursed.
Elias Vamvakas, TearLab's Chief Executive Officer said, "The majority of eye care practitioners are unaccustomed to the requirements of CLIA regulations and, as a result, may be reluctant to enter into the certification process on their own. This collaboration will make the process simple and straightforward for doctors, with all of the paperwork and bureaucracy being handled by COLA. Simplifying the process will allow for greater access to the TearLab™ Osmolarity System -- raising the standard of care while, at the same time, providing the necessary economics for doctors to build a successful Dry Eye practice."
Douglas Beigel, COLA's Chief Executive Officer commented, "As an organization dedicated to promoting excellence in laboratory medicine and patient care, we welcome the opportunity to work with eye care practitioners interested in qualifying as a Laboratory Director for Moderate Complexity, to help them meet CLIA requirements to provide TearLab Osmolarity testing. Completing COLA's program means that they will be in compliance with CLIA, which also is recognized by the Joint Commission on Accreditation of Healthcare Organizations (TJC)."
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™ 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 COLA
COLA accredits almost 8,000 medical laboratories and provides the clinical laboratory with a program of education, consultation, and accreditation. The organization is an independent, non-profit accreditor whose education and standards enable clinical laboratories and staff to meet U.S. CLIA and other regulatory requirements. For more information about COLA accreditation services and educational products, and online educational opportunities please call 800-981-9883 or visit COLA's web site at www.cola.org.
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.
CONTACT: Investors Stephen Kilmer, President Kilmer Lucas Inc. (905) 690-2400 Ext. 21 stephen@kilmerlucas.com Media Leonard Zehr, Managing Director Kilmer Lucas Inc. (905) 690-2400 Ext. 41 len@kilmerlucas.com