TearLab presents a unique offering in Dry Eye Disease (DED) diagnostics with their TearLab Osmolarity System, a first-of-its-kind platform for objectively quantifying a crucial feature set of the disease, tear film osmolarity in a manner that is rapid, easy, and highly accurate.
Percentages of sufferers from DED in the US and Asia are as high as 13% (Schein 1997) and 33% (Shimmura 1999) respectively in reported incidence cases. This is a huge market with massive potential for TearLab, which presents a novel solution to clinicians for both diagnosis and management of the disease. The TearLab Osmolarity System consists of a portable counter-top reader/base unit and pen which uses test cards to harvest nanometric quantities of the patient’s tears without ever touching the eye. The pen is then placed back into the reader which calculates osmolarity data according to TEAR’s ingenious method.
A 2009 American Academy of Ophthalmology patient trial of 300 found that osmolarity correctly identified 95% of severe cases of DED (88% normal, 75% mild/moderate, all at a cut-off rate of around 308 mOsms/L). The TEAR system was shown to outperform extant methods of diagnosis for mild/moderate cases (Sullivan 2009) and uses the aforementioned method for rapidly assaying via the TearLab Osmolarity Test.
The end result is a simple, self contained, lab-on-a-chip system that lets clinicians rapidly diagnose DED using a simplified, categorical descriptor set that clearly shows osmolarity value, allowing for confident diagnosis. Incorporated into the workflow, this professional in vitro diagnostic platform, which also features a two-card electronic check card system and quality control solutions for calibration purposes, gives medical professionals the kind of fast/accurate benchmarking they need to accelerate patient care. The number is psychologically valuable as well, being able to show patients they have dry eye disease according to a quantifiable vector achieved via rapid analysis after sampling the aqueous fluid helps doctors educate patients otherwise reluctant to even take the condition seriously.
Another recent report (Feb 23) has TEAR moving to secure abundant space in the Japanese market via entry into a material definitive agency agreement to roll the TearLab Osmolarity System out there. A 2008 study in Japan to determine the prevalence of DED among young- to middle-aged office workers using visual display terminals found clinically diagnosed DED in as much as 10.1% of men and 21.5% of women.
Recently receiving its CLIA waiver categorization from FDA (Jan 24) for the TearLab Osmolarity System and a positive code decision from Medicare, TEAR stands ready to service clients in assisting with obtaining a Moderately Complex CLIA certificate. TEAR will even provide the costs of any Lab Director course (if needed), and all materials required for assurance of quality testing under CLIA. This is a huge win for TEAR that should give the company serious momentum and investors will be taking a closer look as the TearLab Osmolarity System approaches becoming an established standard of care in the industry.
Having received company-wide ISO 13485:2003 certification early on in the commercialization of the technology, TEAR is a clear beacon of rigorous quality standards in the development of medical devices.
For more information on TearLab Corp. please visit the company’s website at: www.TearLab.com
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