The TearLab Osmolarity test has overcome two key regulatory hurdles
Early this month TearLab announced that they had received communication from the FDA indicating that the Agency had approved its petition for a waiver under CLIA for their Osmolarity System. The good news kept coming last week with the Centers for Medicare and Medicaid Services (CMS) publishing instructions for the reimbursement rate for the TearLab Osmolarity test to be revised to $23.25 per eye, across all US States. "With both the CLIA Waiver and uneven reimbursement obstacles now overcome, we can look forward to the adoption curve of this groundbreaking test steeping significantly in 2012," said TearLab’s CEO, Elias Vamvakas.
"This is great news for TearLab. Having both the CLIA waiver and reimbursement will allow many more people to use the diagnostic system, and we at MiniFAB are looking forward to ramping up our production to meet the increase in demand," said MiniFAB's Manufacturing Manager, Bas Garst.
MiniFAB currently manufactures 70,000 nanofluidic test cards per month for TearLab.