Leading Diagnostic Healthcare Company Signs Contract Manufacturing Agreement in Order to Fulfill Sales of IgE and Lactoferrin DED Diagnostic Assays
SAN DIEGO, CA, Dec. 20, 2023 (GLOBE NEWSWIRE) — via NewMediaWire –AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today that the Company has signed an agreement with contract manufacturer Auer Precision for the production of its two FDA-cleared diagnostic assays designed for point-of-care diagnosis of Dry Eye Disease (DED). The partnership will enable scaling of production quantities of the assays to meet demand for the tests in a cost-effective way.
Until this agreement, the Company has been manufacturing both its ocular T-POC TOTAL IgE Immunoassay and T-POC LACTOFERRIN Immunoassay FDA-cleared Kits in-house. With the assay design validated and sales taking place through its commercialization partner Verséa Ophthalmics, AXIM sought a partner who had a proven track record of best-in-class diagnostic manufacturing who was willing to invest in the necessary infrastructure to support the scaled growth of production of the tests. Auer, whose facilities are ISO Certified has been producing medical diagnostics including later flow assays since 1972, is a market leader in both high precision and next gen product development, making the company a great fit as AXIM’s manufacturing partner. Through the agreement Auer will begin producing both tests as soon as possible to meet the demand of clinicians nationwide as well as scale production as necessary in the coming months.
“AXIM is a research and development company and from a strategic standpoint, selecting a great partner for manufacturing will enable us to focus on what we do best while generating revenue on our already proven tests in the most efficient way,” said John Huemoeller II, CEO of AXIM Biotechnologies. “While we have been able to meet the demands of regulatory agencies and some orders by in-house manufacturing, the economies of scale afforded by working with a reputable firm like Auer make the partnership a no-brainer. They were quick to prove their understanding of our tests and firm in their ability to scale production to meet our needs now and in the future. We look forward to a long and fruitful relationship with them.”
AXIM’s diagnostic assays address a critical unmet need in ophthalmological healthcare where approximately 344 million people worldwide suffer from DED but many clinicians struggle to properly diagnose the disease due to insufficient diagnostic tools. Both of AXIM’s tests are revolutionary in that they were designed to be administered at the point-of-care and render results in nine minutes. The allergen-specific immunoglobulin E (IgE) assay quantitatively measures IgE in samples, enabling clinicians to differentiate between the underlying causes of a patient’s eye condition and prescribe treatment accordingly. Its other test measures levels of Lactoferrin, a protein that exhibits a unique combination of antimicrobial, antiviral and anti-inflammatory properties. Measuring Lactoferrin levels in patients enables clinicians to directly correlate low levels to dry eye disease caused by aqueous deficiency and the severity of DED can be determined by the Lactoferrin level. Low Lactoferrin levels indicate DED and depressed ocular immunity, which may represent an increased surgical risk and of contact lens intolerance.
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: https://www.versea.com/divisions/ophthalmics/
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 www.AXIMBiotech.com.
About Auer Precision
Auer Precision has provided product support and manufacturing solutions for the medical and life sciences industry for over 25 years. Our Medical Products Group works with customers from initial design and prototyping through full commercial realization, including Tier 1 assembly/packaging and supply chain management. We specialize in die-cut (stamping) and automated solutions for disposable microfluidic and lateral flow.
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 www.sec.gov. 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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Source Globe Newswire
