Axim Biotechnologies, Inc. has taken a significant step towards expanding 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. This move is pivotal for the company's strategy to facilitate the integration of its TearScan Lf test into non-laboratory settings, thereby enhancing the diagnosis and monitoring of Aqueous Deficient Dry Eye Disease (ADDE).
The TearScan Lf test, already FDA 510(k)-cleared, is designed to diagnose ADDE by measuring Lactoferrin levels in tears, which are indicative of lacrimal gland function. A CLIA waiver would allow ophthalmologists and optometrists to administer the test without the need for CLIA certification, significantly broadening its clinical use and commercial potential. This development is crucial for patients suffering from ADDE, as it promises a more straightforward path to accurate diagnosis and tailored treatment, avoiding the inefficiencies of trial-and-error approaches.
The Pre-Submission process is a critical first step in engaging with the FDA to align on regulatory expectations and minimize potential delays in the waiver application process. 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 to revolutionize the diagnosis of Dry Eye Disease and ocular allergies in primary eye care settings.
This initiative by Axim Biotechnologies represents a significant advancement in the field of ophthalmological diagnostics, offering hope for earlier and more accessible diagnosis of ADDE. The potential CLIA waiver for the TearScan Lf test could mark a turning point in the management of Dry Eye Disease, providing a practical solution for eye care providers and improving patient outcomes.
