TearLab announced that it has submitted a 510(k) application to the FDA for the potential clearance of its TearLab Discovery Platform, the company's next-generation in-vitro diagnostic testing system. The submission covers the TearLab Discovery Platform and a test card measuring the inflammatory biomarker, MMP-9. TearLab Discovery will also be capable of performing the company's current FDA cleared tear osmolarity test.
TearLab Discovery MMP-9 has an FDA-cleared predicate, which the company believes will have a positive impact on the review period of its application. Additionally, both MMP-9 and the current tear osmolarity test have existing quantitative reimbursement codes in the United States, which the company believes will provide immediate reimbursement upon a potential commercial launch.
"The FDA submission for the TearLab Discovery Platform is a significant milestone for the company, and we are pleased to have finished the filing process. We are optimistic about the completeness of the package we submitted, and we look forward to engaging with the agency during the review process," Seph Jensen, TearLab's Chief Executive Officer, said in a company news release. "Discovery has garnered significant positive feedback from members of the eye care community since its introduction at the European Society of Cataract and Refractive Surgeons Annual Meeting in October 2017, and we continue to believe in the platform's potential to address a significant unmet need for effective, objective tools to diagnose ophthalmic conditions."
The company previously announced a new business model that will focus its commercialization efforts on supporting existing customers, concentrating resources on completing the development of its TearLab Discovery Platform and reducing its cash burn. Consistent with these priorities, the company plans to file for Waiver categorization with the FDA under the Clinical Laboratory and Improvement Amendments (CLIA) after it receives FDA 510(k) clearance for the TearLab Discovery Platform to allow the test to be performed at the point-of-care. Both the MMP-9 predicate device and the current TearLab osmolarity test have existing CLIA Waivers to allow point-of-care testing. In the interim, the company will continue to build the clinical data package for the commercial launch of the TearLab Discovery Platform which it expects after securing both the FDA clearance and the CLIA waiver.