Wednesday, November 4, 2009

Diagnostics: TearLab trial results

Sounds like they have made some really good progress with this now:

TearLab Presents Results of Landmark Dry Eye Trial at AAO -- PAAO 2009 Joint Meeting


SAN DIEGO, Oct. 26, 2009 (GLOBE NEWSWIRE) -- OccuLogix, Inc. dba TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) announced that Gary Foulks, MD, FACS, presented the poster, "Osmolarity as a Biomarker for Disease Severity in Mild to Moderate Dry Eye Disease," from the TearLab Osmolarity Core Validation Study today at the 2009 American Academy of Ophthalmology (AAO) and Pan American Ophthalmology (PAAO) joint meeting in San Francisco, California.

Dry Eye Disease and a New Severity Index

Data from this landmark study compares the results of individual clinical evaluations to Dry Eye Disease (DED) severity. Over 300 subjects were evaluated in 10 sites worldwide, and for the first time a comprehensive index has been created to classify patients into Normal, Mild/Moderate or Severe categories using an objective and quantitative analysis.

"DED has traditionally been very difficult to diagnose in early and mild stages due to compensatory mechanisms that are in effect during the early transitory phases of the disease. This difficulty to diagnose early stage disease has long been a confounding problem to clinicians and pharmaceutical companies alike. Data from this study clearly demonstrates that in earlier stages of disease, osmolarity shows a progressive increase with increasing severity," stated Dr. Foulks.

Elias Vamvakas, Chairman and Chief Executive Officer of TearLab Corporation, commented, " We are very excited about the results of this study. The demonstrated accuracy and sensitivity of our lab-on-a-chip technology is a breakthrough that will enable doctors to easily diagnose and effectively manage patients with DED. In addition we believe the test will become the catalyst to effective drug development and appropriate prescription."

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 is a breakthrough test that will enable doctors to easily diagnose and effectively manage patients with Dry Eye Disease. 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 and is intended to be technician administered.

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