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TearLab osmolarity test not approved for CLIA waiver classification

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SAN DIEGO — TearLab Corporation did not gain approval from the U.S. Food and Drug Administration for its Clinical Laboratory Improvement Amendments certificate application, the company announced in a press release.

The FDA said TearLab submitted insufficient data for the TearLab Osmolarity System to receive CLIA waiver classification, which would allow eligible offices to be reimbursed for the test.

The company recently launched a program that would help interested eye care professionals meet moderate complexity CLIA standards.

"With FDA 510(k) approval, Medicare reimbursement and more than 120 doctors having already completed all of the program steps — 20 of which having received their Lab Director's certifications to-date — we are fully engaged in our U.S. commercialization program," Elias Vamvakas, CEO of TearLab, said in the release.