AXIM Biotechnologies has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for a next-generation in vitro diagnostic test that measures lactoferrin levels in tears to help identify aqueous deficient dry eye disease. The move, announced via NEWMEDIAWIRE, represents a significant step toward modernizing tear-based diagnostics and shifting dry eye assessment from subjective symptom reporting to objective, point-of-care measurement.
The importance of this submission lies in its potential to change how eye care providers diagnose and manage a condition that affects an estimated 16 million adults in the United States, according to the Tear Film & Ocular Surface Society. Dry eye disease is one of the most common reasons patients seek care from an eye care professional, yet diagnosis often relies on patient-reported symptoms and subjective clinical observation. AXIM's test is designed to provide a rapid, objective lactoferrin measurement directly in the examination room, addressing a long-standing gap in clinical practice.
AXIM's new test builds on its previously FDA-cleared Touch Scientific Lactoferrin Microassay System, which used a multi-step, ELISA-based colorimetric method. The next-generation system replaces that workflow with a streamlined lateral-flow format using gold nanoparticle detection, read by a compact instrument, while preserving the same proven antibody chemistry. According to the company, the result is a test built around the realities of a busy clinic: fewer steps, faster results, and a simpler workflow that fits into a routine eye exam. Dr. Sergei A. Svarovsky, Chief Scientific Officer of AXIM Biotechnologies, who led the development, stated that the new rapid format lets clinicians get clear results in just 10 minutes directly in the examination room during a patient's visit.
The clinical implications are substantial. 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 Svarovsky noted that aqueous deficient dry eye is often missed because current diagnostic tools are outdated. A simple, point-of-care test could help providers spot the condition earlier, start effective treatment sooner, and easily monitor patient progress.
Following FDA clearance, AXIM intends to request that the test be categorized as CLIA-waived. A waived categorization would allow the test to be performed in a far broader range of settings, including optometry and ophthalmology offices, without the need for a moderate-complexity laboratory, significantly expanding patient and clinician access to objective dry eye testing. Catalina Valencia, CEO of AXIM, called the submission a defining moment for the company, emphasizing that the 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. If cleared and ultimately granted CLIA waiver, AXIM's test could become a routine tool in eye care, enabling earlier intervention and better outcomes for millions of patients.
