Thursday, October 14, 2010

Device news: TearLab osmolarity test making strides...

Medicare to Reimburse for TearLab Test
San Diego Business Journal
11 October 2010

San Diego-based TearLab Corp., which is developing therapies for dry eye disease, announced that the Committee for Medicare and Medicaid Services on Oct. 8 published a proposed reimbursement rate for the company’s osmolarity test. Starting in January, the government will reimburse doctors for the test at $24.01 per eye.

Reimbursement by CMS will only be available for doctor’s offices that have a moderate/complex clinical laboratory improvement amendments certificate until TearLab receives CLIA waiver categorization from the Food and Drug Administration. This waiver is currently under review by the FDA.

Osmolarity, or the measurement of salt content in a patient’s eyes, is the accepted standard for objectively diagnosing dry eye disease.


And while we're on the subject:

TearLab Announces Issuance of Core U.S. Patent
October 13 - Wall Street Journal

SAN DIEGO, Oct 13, 2010 (GlobeNewswire via COMTEX) -- TearLab Corporation (TEAR 2.85, -0.02, -0.70%) today announced that it has been granted U.S. Patent No. 7,810,380, entitled "Systems and methods for collecting tear film and measuring tear film osmolarity." This patent provides the company with broad and blocking intellectual property regarding the measurement of genetic and protein biomarkers within the tear film.

The patent, which will expire in 2029, allows TearLab to build upon its non-invasive tear collection platform to explore biomarkers across a wide range of disease states. This includes, but is not limited to, the Company's initial commercial target of Dry Eye Disease.

No comments: