TearLab Corporation has received clinical laboratory improvement amendments (CLIA) wavier from the US Food and drug administration (FDA) for its TearLab Osmolarity System.

The TearLab Osmolarity System utilizes a lab-on-a-chip approach that requires less than 50 nanoliters (nL) of tear fluid to measure tear osmolarity.

The system can produce a sample-to-answer result in less than 30 seconds and eliminate the challenges that previously prevented point-of-care osmolarity testing.

TearLab CEO Elias Vamvakas said they 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 TearLab Osmolarity test is now well on its way toward being established as a standard of care.