The test is slated for further clinical development in the first quarter of 2023 and, once FDA approved, will be added to the company's catalog of ophthalmological diagnostic tools available to clinicians throughout North America.
The company noted in a news release that the test is designed to be administered at the point-of-care and will measure both IgE and MMP-9 levels in patients, rendering results in 10 minutes.
AXIM Biotechnologies Inc. has filed a provision patent application with the U.S. Patent and Trademark Office on an innovative new rapid ophthalmological diagnostic solution designed to reliably measure both 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 FDA approved, will be added to AXIM’s expanding catalog of ophthalmological diagnostic tools available to clinicians throughout North America.
The company noted in a news release that the test is designed to be administered at the point-of-care and will measure both IgE and MMP-9 levels in patients, rendering results in 10 minutes. Unlike other MMP-9 tests commercially available that require a tear sample from patients of up to ~10 microliters, AXIM’s new dual test will be able to measure both IgE and MMP-9 levels in a 20-2,000ng/mL using just a two microliter sample.
This sample size significantly reduces patient discomfort in tear collection, where only one sample is needed to measure levels of both biomarkers. Additionally, other commercially available tests only provide a qualitative result (positive/negative) whereas AXIM’s new test measures actual levels of each biomarker, enabling clinicians to differentiate between the underlying causes of a patient’s eye condition and prescribe treatment accordingly and instantly at the point-of-care.
“This test is a revolution in the field of ophthalmological diagnostics, as it enables clinicians to more accurately diagnose and treat the millions of patients suffering from common eye conditions such as Dry Eye Disease (DED), which is commonly misdiagnosed and mistreated,” John Huemoeller III, CEO of AXIM Biotechnologies, said in the news release.
According to Huemoeller, this test was designed with clinicians in mind.
“For example, one of its key benefits is that it provides twice as much information to clinicians in a single test, versus the current standard that requires two separate tests,” he said in the release. “Given the amount of time clinicians are able to spend with patients and the number of patients seen in a given day, we foresee this as a major differentiator in the marketplace which will lead to increased adoption of our tests.”
Once developed and cleared, the test will be added to AXIM’s growing portfolio of FDA-cleared ophthalmological diagnostics tools, which includes rapid point-of-care tests for both IgE and Lactoferrin. The new combination test measures levels of matrix metalloproteinase, or MMP-9, in patient tear samples, along with IgE which is a key biomarker primarily associated with non-specific, allergic conjunctivitis, which often mimics Dry Eye Disease.
According to the company, MMP-9 is an enzyme that has been linked to signs of inflammation on the surface of the eye. This inflammation can be caused by a variety of indications including dry eye or chemical or mechanical damage to the eyes. The higher the level of MMP-9, the higher the degree of inflammation. Upon review of the results of the new test, clinicians will be able to prescribe either anti-inflammatory, antihistamine or both promptly during a patient’s 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 that number is growing in both young and old adults, making it imperative that clinicians figure out how best to diagnose and treat it. A 2017 study reported an estimated 6 million people reported having experienced Dry Eye Disease symptoms but had never been diagnosed. AXIM’s diagnostic solutions seek to address this severely unmet clinical need and the addition of this test to AXIM’s portfolio only further positions the company as a leader in innovative ophthalmological diagnostic solutions.
For more information on AXIM’s diagnostic solutions or to speak with someone at AXIM’s commercialization partner Verséa about adding these innovative solutions to your clinic, visit https://www.versea.com/divisions/ophthalmics/.