Axim Biotechnologies, Inc. has taken a significant step toward broadening the accessibility of its Lactoferrin diagnostic test by filing a Pre-Submission with the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) Waiver. The TearScan Lf test, already FDA 510(k)-cleared, is designed to diagnose Aqueous Deficient Dry Eye Disease (ADDE) by measuring lactoferrin levels in tears, which are reduced in 80% of ADDE patients.
The pursuit of a CLIA Waiver is pivotal as it would allow the test to be administered outside traditional laboratory settings, by ophthalmologists and optometrists, without the need for CLIA certification. This change could significantly enhance the test's clinical utility and commercial adoption, making it easier for eye care providers to diagnose and monitor ADDE and other forms of Dry Eye Disease.
Following the Pre-Submission, Axim Biotechnologies anticipates FDA feedback within 60 days, after which it plans to conduct a comparative clinical study to support its CLIA Waiver Application. The company's CEO, Catalina Valencia, emphasized the transformative potential of securing CLIA waivers for both the Lactoferrin and IgE tests, highlighting the opportunity for earlier and more accessible diagnosis in primary eye care settings.
The move represents a strategic effort by Axim Biotechnologies to leverage its FDA-cleared diagnostic tests to capture a larger share of the Dry Eye Disease diagnostic market, while addressing the need for more efficient and accessible diagnostic tools in ophthalmology.
