AXIM Biotechnologies Launches Revenue-Generating IgE Diagnostic Validation Assays Nationwide

Advanced IgE Diagnostic Assays Now Available for Nationwide Distribution, Driving Revenue Growth for AXIM® Biotechnologies

AXIM Biotechnologies, an international healthcare diagnostic solutions development company, announced today that it has begun shipping revenue generating validation kits of one of its ophthalmological diagnostic assays. The proprietary assay is designed for the diagnosis of dry eye disease (DED) in patients at the point-of-care by measuring levels of Ocular Immunoglobulin E (IgE), a key biomarker primarily associated with non-specific, allergic conjunctivitis, which often mimics DED.

The Company had previously announced the commencement of commercial manufacturing of its IgE FDA-cleared ocular assays and this shipment marks the first commercial order fulfilment of the IgE assay since its development, a major milestone in the Company’s progress toward becoming a major revenue-generating diagnostic solutions company. 

The Company announced on May 24, 2023, it’s commercialization partner Verseá Ophthalmics had over 40 clinic commitments and that number now seven weeks later stands at over 50. As part of the onboarding process for clinics, each of the clinics either currently have their CLIA moderate complexity license or are in the application process. Once they have their CLIA license the Company sends the validation kit, along with a reader that is used to interpret results, and the clinics run the required amount of tests to validate the reader. Once initial validation testing is done, the Company anticipates clinics will begin monthly reordering of tests. Additionally, AXIM’s partner Verseá Ophthalmics continues to meet with clinics regarding the diagnostic assay platform and continues acquiring additional commitments.

“After years of research and development on our diagnostic program, today we are able to announce that our solutions are on their way to clinics to begin helping patients improve their lives – a milestone I could not be prouder of,” said John Huemoeller II, CEO of AXIM Biotechnologies. “Through Verséa Ophthalmics, we have been showcasing our solutions to clinicians for the past few months while we have been scaling manufacturing, and the response has been fantastic. Our solutions provide much-needed tools to diagnosing one of the most widespread issues in the field of ophthalmology: DED. We look forward to further on-boarding these clinics and adding new ones week after week.”

The IgE diagnostic assay was designed to be administered at the point-of-care, and quantitatively measures IgE levels in patients, rendering results in eight minutes. Unlike other clinically available assays, AXIM’s test measures actual levels of IgE, 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.

While currently all clinics working with the assays must be CLIA-moderate complexity certified before they can run tests, the Company is preparing the appropriate research trial and will submit the applicable paperwork to the regulatory body seeking a CLIA-waiver, once the trial is accomplished.  Once the waiver is approved it will exponentially increase the market opportunity of the tests.

AXIM’s tests address a critical unmet need in ophthalmological healthcare marketplace where approximately 344 million people worldwide suffer from DED. Historically, clinicians have struggled to properly diagnose and treat DED where an estimated six million people have experienced DED symptoms but had never been diagnosed due to the lack of quantitative diagnostic tools. AXIM aims to address this discrepancy with its ocular diagnostic solution portfolio, beginning with the IgE assay. Beyond initial diagnosis, consistent testing is required to evaluate the efficacy of treatment for DED, creating a recurring need for AXIM solutions at the point-of-care.

Published on : 13th July, 2023