Curated News
By: NewsRamp Editorial Staff
October 06, 2026
AXIM Submits 510(k) for Rapid Dry Eye Test, Eyes CLIA Waiver
TLDR
- AXIM's new dry eye test could give providers a first-mover advantage with rapid, objective lactoferrin results in the exam room.
- AXIM submitted a 510(k) for a lateral-flow lactoferrin test using gold nanoparticles, delivering results in 10 minutes and seeking CLIA waiver.
- AXIM's rapid dry eye test could help millions receive earlier diagnosis and timely treatment, improving daily comfort and eye health.
- AXIM's dry eye test uses gold nanoparticles to detect lactoferrin in tears, offering results in just 10 minutes during an eye exam.
Impact - Why it Matters
This news matters because dry eye disease is a widespread and often frustrating condition for both patients and clinicians. Current diagnostic methods are frequently subjective, leading to misdiagnosis or delayed treatment. An objective, rapid test for lactoferrin could enable earlier and more accurate identification of aqueous deficient dry eye, allowing for targeted therapies and better monitoring. By seeking CLIA waiver, AXIM aims to make this test accessible in routine eye care settings, potentially revolutionizing how dry eye is managed. For the millions of Americans suffering from dry eye, this could mean faster relief and more personalized care. Moreover, it signals a broader trend toward point-of-care diagnostics in ophthalmology, which could improve efficiency and patient outcomes.
Summary
AXIM Biotechnologies, Inc. (OTC: AXIM) has taken a significant step toward transforming dry eye 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. Following FDA clearance, AXIM plans to seek CLIA-waived categorization, which would allow the test to be performed in a wider range of clinical settings, including optometry and ophthalmology offices, without the need for a moderate-complexity laboratory. This move is part of AXIM's broader strategy to modernize tear-based diagnostics and bring objective, easy-to-use testing to the point of care.
The new test builds on AXIM's previously FDA-cleared Touch Scientific Lactoferrin Microassay System, which used a multi-step ELISA-based method. The next-generation system employs a streamlined lateral-flow format with gold nanoparticle detection, read by a compact instrument, while preserving the same proven antibody chemistry. This redesign reduces steps, speeds up results, and simplifies workflow, making it suitable for routine eye exams. According to Dr. Sergei A. Svarovsky, Chief Scientific Officer, the test delivers clear results in just 10 minutes, directly in the examination room. CEO Catalina Valencia called the submission a defining moment for AXIM, emphasizing that the test can provide eye care providers with rapid, objective information to assess aqueous-deficient dry eye and support treatment planning.
Dry eye disease affects an estimated 16 million adults in the United States, according to the Tear Film & Ocular Surface Society, yet diagnosis often relies on subjective symptoms and clinical observation. Lactoferrin, a protein secreted by the lacrimal gland, is a well-established biomarker of tear production, and low levels can help clinicians identify aqueous deficiency. AXIM's diagnostic program complements its 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 also includes rapid tear-based tests for lactoferrin and IgE. For more information, visit www.aximbiotech.com. This news was announced via NEWMEDIAWIRE.
Source Statement
This curated news summary relied on content distributed by NewMediaWire. Read the original source here, AXIM Submits 510(k) for Rapid Dry Eye Test, Eyes CLIA Waiver
