TearLab Corp. announced that its proprietary tear osmolarity analysis test (TearLab Osmolarity System) has been granted FDA waiver categorization under the Clinical Laboratory Improvement Amendments of 1988.
San Diego-TearLab Corp. announced that its proprietary tear osmolarity analysis test (TearLab Osmolarity System) has been granted FDA waiver categorization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
“We believe that with CLIA waiver and Medicare reimbursement in place, and with the updated American Academy of Ophthalmology's Preferred Practice Pattern guidelines listing tear osmolarity as a more sensitive method to diagnose dry eye disease, [the proprietary test] is now well on its way toward being established as a standard of care,” said Elias Vamvakas, TearLab's chief executive officer.
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