AXIM® Biotechnologies Files Provisional Patent on Novel Methodology for Use in Optical Diagnostic Assay Manufacturing
Leading Diagnostic Healthcare Company Announces Provisional Patent Filing on Proprietary Use of Materials for Ophthalmological Test Strip Manufacturing
SAN DIEGO, CA, March 14, 2023 (GLOBE NEWSWIRE) -- via -- . () (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today the filing of a provisional patent application with the U.S. Patent and Trademark Office (US PTO) for the innovative use of proprietary materials in its ocular diagnostic assays that significantly increases sample disbursement. This development increases efficacy and accuracy of diagnostic test readings as well as usability for clinicians.
AXIM's diagnostic assays are unique in that they require a significantly reduced tear sample from patients, greatly increasing the ease of collection at the point-of-care from clinicians. Where most commercially available tests require a tear sample size up to ~10 microliters, AXIM's solutions measure biomarker levels with just 1 microliter. Given the smaller sample size requirements, existing mechanisms for sample disbursement proved less than optimal. As such, AXIM’s research and development team has developed a new and proprietary methodology for tear sample disbursement within a given assay, which is showing considerable evidence of increased sensitivity, specificity and accuracy of measurement readings as well as useability.
Legacy materials have shown evidence of inconsistent disbursement of the tear sample in test areas, creating lower accuracy test results given a smaller sample size. AXIM's new methodology ensures unparalleled consistency in tear sample disbursement and a color indication shows the correct application of the sample into the assay by clinicians. This application greatly increases the accuracy of administered tests and useability by clinicians.
"This innovation is yet another step in the execution of a long-planned, go-to-market strategy for AXIM's diagnostic solutions,” said John Huemoeller II, CEO of AXIM Biotechnologies. “Being able to combine a very small tear sample from patients with optimized test accuracy results has created an overall platform that is truly a step above the rest and a significant advancement in terms of patient comfort and clinician application at the point-of-care.”
Huemoeller added: “We have begun implementing the proprietary technique into our assays and plan to integrate it into commercially available tests as the next stage in our manufacturing begins, which we expect shortly."
AXIM's research and development team has been building a world-class portfolio of FDA-cleared ophthalmological diagnostics tools, including its commercialized rapid point-of-care tests for both IgE and Lactoferrin. Each test renders a biomarker level reading in just eight minutes and is administered at the point-of-care. While other tests are in development, the two FDA-cleared assays, which are being marketed and sold through a commercialization partner, seek to address the severe discrepancy in patients experiencing symptoms of Dry Eye Disease (DED) and those actually diagnosed with the disease. According to the American Academy of Ophthalmology, approximately 20 million people in the United States have been diagnosed with DED, while a study done by the American Journal of Ophthalmology reported an estimated six million additional people reported having experienced Dry Eye Disease symptoms but had never been diagnosed. AXIM is seeking to address this through its existing and under-development portfolio of 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, please visit: .
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dye Eye Disease. For more information, please visit .
Forward-Looking Statements
The statements made by Axim Biotechnologies Inc., in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will ever be approved for use by the U.S. FDA or any equivalent foreign regulatory agency. Further, Axim’s eye care diagnostic products that are FDA cleared may not be manufactured in large enough quantities or that third parties with established eye care physicians will enter into agreements or purchase from the Company, and even if the Company’s diagnostic candidates are successful, they may generate only limited revenue and profits for the Company. Various other factors are detailed from time to time in Axim’s SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2022, and other reports we file with the SEC, which are available at . Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
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