Company remains on-track to Submit 510(k) application in 2017. TearLab provided an update on the regulatory strategy for its TearLab Discovery™ System, the Company’s next-generation in-vitro diagnostics testing platform. Based on a reassessment of its regulatory and reimbursement considerations, the Company has elected to pursue initial U.S. Food and Drug Administration (FDA) clearance of a test card measuring a single inflammatory biomarker, MMP-9, in combination with our FDA cleared osmolarity test.

TearLab had previously planned to seek clearance of a test card containing a total of two inflammatory biomarkers plus osmolarity to aid in the diagnosis and management of dry eye disease. This change in regulatory strategy is not expected to impact the prior guidance in relation to the timing of the filing of the Company’s FDA 510(k) application for clearance of the TearLab Discovery System. The Company remains on track to submit its application by the end of 2017. Additionally, the Company believes that the revised strategy can reduce the review period of the application since the inflammatory biomarker selected, MMP-9, has an FDA cleared predicate.

Both the osmolarity and MMP-9 biomarkers have existing quantitative reimbursement codes in the U.S., which the Company believes will provide immediate and favorable reimbursement upon commercial launch.

Based on a comprehensive review of the best regulatory and reimbursement outcome for our first test on the Discovery™ System, we determined that seeking initial clearance of a single inflammatory biomarker in combination with our osmolarity test, will provide the most expeditious regulatory path as well as increased clarity on reimbursement expectations,” said Seph Jensen, TearLab’s Chief Executive Officer. “We are excited about the clinical and commercial potential of our Discovery System and believe that our updated U.S. regulatory strategy is the best path forward for our first test on the new platform. Furthermore, we remain committed to incorporating additional biomarkers through the Discovery platform that bring value to doctors and patients in the diagnosis and management of a variety of eye diseases.”

Source: https://www.tearlab.com/