AXIM Biotechnologies Submits 510(k) to FDA for Next-Generation, Rapid Point-of-Care Tear Lactoferrin Test for Dry Eye Disease 06.10.2026, 15:00 Uhr von EQS News Jetzt kommentieren: 0

Simplified, Modernized Lateral-flow Test is Designed to put a Fast, Objective dry eye Measurement Directly in the Hands of eye Care Providers; Company Plans to Pursue CLIA Waiver Following Clearance

SAN DIEGO, CA - October 6, 2026 (NEWMEDIAWIRE) - AXIM Biotechnologies, Inc. ("AXIM" or the "Company") (OTC: AXIM) today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its next-generation in vitro diagnostic (IVD) test that measures lactoferrin levels in tears as an indicator of aqueous deficient dry eye disease. The submission marks a major milestone in AXIM's strategy to modernize tear-based diagnostics and bring objective, easy-to-use testing to the point of care.

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.

A Proven Biomarker, Modernized for Today's Practice

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.

Commenting on the 510(k) submission, 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, AXIM's diagnostic program complements the Company'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."

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.

"Our main focus was to keep the clinical accuracy of the original test while making it much easier to use," said Dr. Sergei A. Svarovsky, Chief Scientific Officer of AXIM Biotechnologies, who led the development. "This new rapid format lets clinicians get clear results in just 10 minutes, directly in the examination room during a patient's visit."

"Aqueous deficient dry eye is often missed because current diagnostic tools are outdated," Dr. Svarovsky added. "A simple, point-of-care test helps providers spot the condition earlier, start effective treatment sooner, and easily monitor patient progress."

About AXIM Biotechnologies, Inc.

AXIM Biotechnologies, Inc., headquartered in San Diego, California, is a company focused on innovative diagnostics and therapeutic technologies for ocular health, with an emphasis on dry eye disease. The Company's portfolio includes rapid tear-based diagnostic tests for lactoferrin and IgE and its patent-pending LacriShield™ microencapsulated lactoferrin technology. For more information, visit www.aximbiotech.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the FDA review and potential clearance of the Company's 510(k) submission, the timing thereof, the Company's plans to seek CLIA waiver categorization, the anticipated benefits and adoption of its diagnostic products, and the Company's patent application. Words such as "intends," "plans," "expects," "anticipates," "potential," "will," and similar expressions identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including the possibility that FDA may request additional information or may not clear the device, that CLIA waiver may not be granted, that patent protection may not issue, and the Company's ability to obtain financing and commercialize its products. AXIM undertakes no obligation to update these statements except as required by law.

Media & Investor Contact:
Catalina Valencia, Chief Executive Office
AXIM Biotechnologies, Inc.
Catalina@aximbiotech.com