510(k) application submitted to FDA for TearLab Discovery platform

TearLab has submitted a 510(k) application to the FDA for its TearLab Discovery in vitro diagnostic testing system.

The next-generation system includes a test card to measure the inflammatory biomarker MMP-9, as well as the company’s tear osmolarity test, which is already cleared by the FDA.

“The Discovery platform will be able to multiplex multiple proteins on a single test,” TearLab CEO Seph Jensen told Healio.com/OSN. “Doctors are going to get information about both core mechanisms of dry eye — elevated, abnormal osmolarity as well as inflammation. We think it will be a lot more intuitive and actionable with how the doctors interact with the test result.”

Physicians will be able to use the same workflow as the existing TearLab test but will have the ability to quickly gather more data in order to guide the management of dry eye patients, he added.

Both the MMP-9 test, which has an FDA-cleared predicate, and the tear osmolarity test have existing quantitative reimbursement codes in the United States, which the company believes will provide immediate reimbursement upon commercial launch, according to a company press release.

“We’re optimistic the package we are submitting is complete and not introducing any new variables,” Jensen said. “This is really the first step for us fulfilling TearLab’s mission of pioneering the future of tear film diagnostics.” – by Rebecca L. Forand