AXIM Biotechnologies, Inc. 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 on October 6, 2026, marks a significant step in the company’s strategy to modernize tear-based diagnostics and bring objective, easy-to-use testing to the point of care.
Dry eye disease is one of the most common reasons patients seek care from an eye care professional, affecting an estimated 16 million adults in the United States alone, according to the Tear Film & Ocular Surface Society. 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.
AXIM’s new test builds on its 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.
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, stated, “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. We look 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.”
Dr. Sergei A. Svarovsky, Chief Scientific Officer of AXIM Biotechnologies, who led the development, said, “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, “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.”
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. The company’s portfolio includes rapid tear-based diagnostic tests for lactoferrin and IgE. For more information, visit NEWMEDIAWIRE.
