Axim Biotechnologies Seeks FDA CLIA Waiver for Lactoferrin Diagnostic Test

Axim Biotechnologies, Inc. has taken a significant step towards broadening the accessibility of its TearScan Lf 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 indicative of lacrimal gland function.

The pursuit of a CLIA Waiver is aimed at eliminating the need for CLIA certification, thereby enabling ophthalmologists and optometrists to administer the test in non-laboratory settings. This move could significantly enhance the test's clinical utility and commercial adoption by making it more accessible to eye care providers. The FDA's feedback on the Pre-Submission is expected within 60 days, after which Axim plans to conduct a comparative clinical study to support its CLIA Waiver Application.

Currently, the administration of the Lactoferrin test requires CLIA certification and adherence to laboratory protocols. A waiver would not only simplify the process but also allow for the monitoring of treatment response and disease progression over time through repeated testing. This development represents a pivotal moment in Axim's strategy to facilitate the integration of its diagnostic tests into everyday clinical practice, potentially transforming the diagnostic landscape for Dry Eye Disease and ocular allergies.