AXIM Biotechnologies, Inc. (OTC: AXIM) 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 as an indicator of aqueous deficient dry eye disease. The submission, announced through NEWMEDIAWIRE, represents a significant step toward modernizing tear-based diagnostics and moving objective testing into the point-of-care setting. If cleared, the test is intended to be categorized as CLIA-waived, which would allow it to be performed in a far broader range of settings, including optometry and ophthalmology offices, without the need for a moderate-complexity laboratory. That change would markedly expand patient and clinician access to objective dry eye testing.
The new test builds on AXIM's Touch Scientific Lactoferrin Microassay System, a previously FDA-cleared predicate device. While that predicate relied on a multi-step, ELISA-based colorimetric method, AXIM's next-generation system uses a streamlined lateral-flow format with gold nanoparticle detection, read by a compact instrument, while preserving the same proven underlying antibody chemistry. The result is a test designed around the realities of a busy clinic: fewer steps, faster results, and a simpler workflow that fits into a routine eye exam. According to Dr. Sergei A. Svarovsky, Chief Scientific Officer of AXIM Biotechnologies, who led the development, the new rapid format lets clinicians get clear results in just 10 minutes, directly in the examination room during a patient's visit.
The implications of this announcement extend beyond a single product. Dry eye disease is one of the most common reasons patients seek care from an eye care professional, according to the Tear Film & Ocular Surface Society, affecting an estimated 16 million adults in the United States alone. Yet 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. A simple, point-of-care test helps providers spot the condition earlier, start effective treatment sooner, and easily monitor patient progress, as Dr. Svarovsky noted.
Catalina Valencia, CEO of AXIM, called the submission a defining moment for the company. She stated 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 company has taken a biomarker with a long clinical track record and modernized and simplified the test for today's clinic. AXIM looks forward to working with FDA through the 510(k) review and clearance process and, ultimately, to putting this tool in the hands of clinicians nationwide.
The diagnostic program also 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. However, the press release includes forward-looking statements subject to risks and uncertainties, including the possibility that FDA may request additional information or may not clear the device, that CLIA waiver may not be granted, and that patent protection may not issue. AXIM undertakes no obligation to update these statements except as required by law. Still, the submission signals a potential shift toward more objective, accessible dry eye diagnostics, which could improve earlier detection and treatment monitoring for millions of patients.
