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AXIM® Biotechnologies Commences Commercial Manufacturing of FDA-Cleared Proprietary Ocular Diagnostic Assays
AXIM® Biotechnologies Commences Commercial Manufacturing of FDA-Cleared Proprietary Ocular Diagnostic Assays.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\n Leading Diagnostic Healthcare Company Begins Manufacturing of Ocular Immunoglobulin (IgE), Lactoferrin Tests to Fulfill Orders From Commercialization Partner SAN DIEGO, CA, April 11, 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 the start of manufacturing of both its proprietary Ocular Immunoglobulin E (IgE) and Lactoferrin diagnostic assays to fulfill the orders placed by its commercialization partner. As is a standard manufacturing practice, AXIM has begun manufacturing three separate lots of each assay that will be used for an internal reproducibility study with the third lot available to ship to customers. AXIM’s current manufacturing capacity is up to 25,000 units per month. Both tests were designed to be administered at the point-of-care, and measure respective biomarker levels in patients, rendering results in just eight minutes. Unlike other clinically available assays, AXIM’s tests are quantitative and measures actual levels of both IgE and Lactoferrin allowing doctors to monitor targeted therapeutics. Lactoferrin is a protein that exhibits a unique combination of antimicrobial, antiviral and anti-inflammatory properties. It is one of the eye’s important immunological defense mechanisms and also is a biomarker used to assess the secretory function of the lacrimal gland. 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. IgE is a key biomarker primarily associated with non-specific, allergic conjunctivitis, which often mimics Dry Eye Disease (DED), 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. “Our research team has been working tirelessly and we’re ready to scale our production to meet the large demand for our tests – and this was a key milestone toward th...