AXIM Biotechnologies, Inc. has taken a significant step toward modernizing dry eye disease diagnosis with the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration for its next-generation in vitro diagnostic test. The test measures lactoferrin levels in tears to identify aqueous deficient dry eye disease, a common but often underdiagnosed condition. The announcement, made via NEWMEDIAWIRE, signals a potential shift in how eye care providers assess and manage dry eye, moving from subjective symptom reporting to rapid, objective measurement in the clinic.
The importance of this submission lies in its potential to address a longstanding gap in dry eye care. According to the Tear Film & Ocular Surface Society, dry eye disease affects an estimated 16 million adults in the United States alone, making it one of the most frequent reasons patients seek eye care. Yet diagnosis often relies on patient-reported symptoms and subjective clinical observation, which can lead to missed or delayed treatment. 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. By providing an objective measure, AXIM's test could enable earlier and more accurate intervention.
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 instead employs a streamlined lateral-flow format with gold nanoparticle detection, read by a compact instrument, while preserving the same proven antibody chemistry. This redesign is intended to fit the realities of a busy clinic: fewer steps, faster results, and a simpler workflow. Dr. Sergei A. Svarovsky, Chief Scientific Officer of AXIM Biotechnologies, who led the development, stated, “Our main focus was to keep the clinical accuracy of the original test while making it much easier to use. This new rapid format lets clinicians get clear results in just 10 minutes, directly in the examination room during a patient's visit.” He added that aqueous deficient dry eye is often missed because current diagnostic tools are outdated, and a simple point-of-care test helps providers spot the condition earlier, start effective treatment sooner, and easily monitor patient progress.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. This could significantly expand patient and clinician access to objective dry eye testing, as it would remove regulatory barriers that currently limit point-of-care testing. 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. We've taken a biomarker with a long clinical track record and modernized and simplified the test for today's clinic.”
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, the test could become a valuable tool for eye care providers, offering a quick and reliable way to identify aqueous deficient dry eye and improve patient outcomes. The FDA review process will determine whether this innovation reaches the clinic, but the submission itself represents a notable advance in the effort to bring objective diagnostics to routine eye exams.
