Axim Biotechnologies, Inc. has taken a significant step towards 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. This test distinguishes ADDE from other forms of Dry Eye Disease, enabling targeted treatment and avoiding ineffective therapies.
The Pre-Submission process is a critical early engagement with the FDA to clarify regulatory expectations and minimize potential delays in the formal waiver application. 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 aims to submit this application later in the year, with the FDA's review typically completed within 90 days.
Currently, the Lactoferrin test requires CLIA certification and adherence to laboratory protocols, limiting its use to certified facilities. A CLIA waiver would allow ophthalmologists and optometrists to administer the test in non-laboratory settings, significantly expanding its clinical use and commercial adoption. Catalina Valencia, CEO of Axim Biotechnologies, emphasized the company's commitment to simplifying the integration of their tests into eye care practices, highlighting the potential for widespread use in primary eye care and beyond.
The pursuit of a CLIA waiver for the TearScan Lf test represents a strategic move by Axim Biotechnologies to enhance the diagnosis and monitoring of Dry Eye Disease, including ADDE and ocular allergy. By making the test more accessible, the company aims to capture a larger share of the diagnostic device market for Dry Eye Disease, offering a semi-quantitative, point-of-care solution that could transform patient care.
