AXIM Biotechnologies, a healthcare diagnostic solutions development company, announced the filing of a provisional patent application with the U.S. Patent and Trademark Office (USPTO) for the use of proprietary materials in its ocular diagnostic assays that significantly increases sample disbursement.

This development aims to increase efficacy and accuracy of diagnostic test readings as well as usability for clinicians.

AXIM’s diagnostic assays 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, the company says.

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 aims to ensure 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,” says 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 Diagnostic Portfolio

AXIM’s research and development team has been building a portfolio of FDA-cleared ophthalmological diagnostics tools, including its commercialized rapid point-of-care tests for both IgE and Lactoferrin, the company says.

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.