AXIM Biotechnologies Develops New Dual IgE/MMP-9 Rapid Ophthalmic Diagnostic Test; submits a provisional patent

The company noted in a press release that the test is designed for point-of-care use and will measure IgE and MMP-9 levels in patients, providing results in 10 minutes.

The company AXIM Biotechnologies Inc. has filed a patent application with the US Patent and Trademark Office for an innovative new rapid ophthalmic diagnostic solution designed to reliably measure ocular immunoglobulin E (IgE) and MMP-9 in a single test.

According to the company, the test is slated for further clinical development in the first quarter of 2023 and, once approved by the FDA, will be added to AXIM’s expanding catalog of ophthalmic diagnostic tools available to clinicians across North America.

The company noted in a press release that the test is designed for point-of-care use and will measure IgE and MMP-9 levels in patients, providing results in 10 minutes. Unlike other commercially available MMP-9 tests that require a patient tear sample of up to ~10 microliters, AXIM’s new dual test will be able to measure IgE and MMP-9 levels in the 20-2000 ng/mL using only a two microliter sample.

This sample size significantly reduces patient discomfort when collecting tears, where only one sample is needed to measure the level of both biomarkers. Additionally, other commercially available tests provide only a qualitative result (positive/negative), whereas AXIM’s new test measures the actual levels of each biomarker, allowing clinicians to distinguish the underlying causes of a patient’s eye condition and prescribe treatment accordingly and instantly at the point-of-care – worries.

“This test is a revolution in the field of ophthalmic diagnostics, enabling clinicians to more accurately diagnose and treat millions of patients suffering from common eye diseases such as dry eye disease (DED), which are often misdiagnosed and poorly treated,” John Huemoeller III, CEO director of AXIM Biotechnologies, said in a press release.

According to Huemoeller, this test was designed with clinicians in mind.

“For example, one of its key advantages is that it provides twice as much information to clinicians in a single test, compared to the current standard that requires two separate tests,” he said in a statement. “Given the amount of time clinicians can spend with patients and the number of patients seen in a given day, we anticipate that this will be a major differentiator in the market that will drive greater adoption of our tests.”

Once developed and approved, the test will be added to AXIM’s growing portfolio of FDA-cleared ophthalmic diagnostic tools, which includes rapid point-of-care tests for IgE and lactoferrin. The new combination test measures levels of matrix metalloproteinase, or MMP-9, in patient tear samples, along with IgE, a key biomarker primarily associated with nonspecific, allergic conjunctivitis, which often mimics dry eye disease.

According to the company, MMP-9 is an enzyme associated with signs of inflammation on the surface of the eye. This inflammation can be caused by a number of indications including dry eye or chemical or mechanical damage to the eyes. The higher the level of MMP-9, the greater the degree of inflammation. After reviewing the results of the new test, clinicians will be able to prescribe either an anti-inflammatory, an antihistamine, or both immediately during a patient visit, greatly increasing patient care and treatment outcomes.

According to the American Academy of Ophthalmology, approximately 20 million people in the United States (344 million people worldwide) have dry eye disease, and this number is increasing in both the young and the elderly, making it imperative that clinicians discover how best to diagnose and treat it. A 2017 study reported an estimated 6 million people who experienced symptoms of dry eye disease but were never diagnosed. AXIM’s diagnostic solutions seek to address this seriously unmet clinical need, and the addition of this test to AXIM’s portfolio only further positions the company as a leader in innovative ophthalmic diagnostic solutions.

For more information about AXIM’s diagnostic solutions or to speak with someone at AXIM’s commercial partner Versé about adding these innovative solutions to your clinic, please visit https://www.versea.com/divisions/ophthalmics/ .

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