AXIM Biotechnologies, Inc. (OTC: AXIM) announced on October 6, 2026, that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation in vitro diagnostic test that measures lactoferrin levels in tears as an indicator of aqueous deficient dry eye disease. The submission represents a significant step in the company’s effort to modernize tear-based diagnostics and bring objective, easy-to-use testing to the point of care. Following FDA clearance, AXIM intends to request CLIA-waived categorization, which would allow the test to be performed in a broader range of settings, including optometry and ophthalmology offices, without the need for a moderate-complexity laboratory.
The new test builds on AXIM’s Touch Scientific Lactoferrin Microassay System, a previously FDA-cleared predicate device that relied on a multi-step, ELISA-based colorimetric method. In contrast, the next-generation system uses a streamlined lateral-flow format with gold nanoparticle detection, read by a compact instrument, while preserving the same proven antibody chemistry. This design aims to reduce steps, speed results, and simplify workflow for busy clinics. According to Dr. Sergei A. Svarovsky, Chief Scientific Officer of AXIM Biotechnologies, who led development, “This new rapid format lets clinicians get clear results in just 10 minutes, directly in the examination room during a patient’s visit.”
Dry eye disease is one of the most common reasons patients seek eye care, affecting an estimated 16 million adults in the United States, according to the Tear Film & Ocular Surface Society. Diagnosis often relies on patient-reported symptoms and subjective clinical observation. Lactoferrin, a protein secreted by the lacrimal gland, is a well-established biomarker of tear production. Low tear lactoferrin levels can help clinicians identify aqueous deficiency, the form of dry eye caused by insufficient tear output, and distinguish it from other causes of ocular surface discomfort. Dr. Svarovsky added, “Aqueous deficient dry eye is often missed because current diagnostic tools are outdated. A simple, point-of-care test helps providers spot the condition earlier, start effective treatment sooner, and easily monitor patient progress.”
Catalina Valencia, CEO of AXIM, commented, “Submitting this 510(k) is a defining moment for AXIM. This new test can give eye care providers in-office rapid, objective information to help assess aqueous-deficient dry eye and support treatment planning and follow-up.” The diagnostic program complements AXIM’s broader focus on ocular surface health, including its LacriShield™ microencapsulated lactoferrin technology, for which a U.S. provisional patent application was filed in July 2026.
For the eye care industry, FDA clearance and a subsequent CLIA waiver could significantly expand access to objective dry eye testing, enabling earlier diagnosis and more targeted treatment. For patients, this could mean faster, more accurate assessments during routine eye exams, potentially reducing the trial-and-error approach often associated with dry eye management. As reported by NEWMEDIAWIRE, the submission marks a major milestone in AXIM’s strategy to modernize tear-based diagnostics. However, the company notes that forward-looking statements are subject to risks, including the possibility that FDA may request additional information or may not clear the device, and that CLIA waiver may not be granted.
