AXIM Biotechnologies, Inc. announced 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?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.