Tear drop
Credit: Peter Finch/Getty Images

AXIM Biotechnologies, a developer of rapid tear drop-based diagnostics, announced today that has successfully developed a tear drop test that is the first rapid, non-invasive, point-of-care diagnostic for Parkinson’s disease (PD). The test detects abnormal alpha-synuclein—an important emerging biomarker of PD—found in a person’s tears.

“Our proven expertise in developing tear-based diagnostic tests has led to the development of this test in record speed and I’m extremely proud of our scientific team for their ability to expand our science to focus on such an important focus area as Parkinson’s,” said John Huemoeller II, CEO of AXIM Biotechnologies.

Recent studies have pointed to α-synuclein as a biomarker that has the potential to differentiate people who have PD from healthy controls. A study released in April of this year by the Michael J. Fox Foundation, published in the journal The Lancet, showed the present of abnormal α-synuclein was detected in 93% of the people with PD who participated in the study. These recent advances in the identification of this biomarker hold the promise to guide therapeutic development by identifying the subgroups based on pathology and establishing biomarker-defined at-risk cohorts of patients.

AXIM—which, to date, has developed two FDA-approved tear-based diagnostics for dry eye disease (DED)—pursued their development of the PD test based on research that showed α-synuclein in its aggregated for can be detected in tears. These studies used a more cumbersome method to detect the presences of α-synuclein, the company noted. This method used the Schirmer Strip collection method to capture the tears, which were then frozen to -80°C before being shipped to a lab for a 30-minute cycle of centrifugation. Total tear protein content is then quantified via a bicinchoninic assay followed by alpha-synuclein detection using a plate reader.

According to AXIM, its detection method avoids these long and costly steps for α-synuclein by providing doctors with a test that can deliver results within 10 minutes at the point-of-care and collects the sample needed non-invasively via tear collection—as opposed sample collection via a spinal tap—for diagnosis.

“With this new assay, AXIM has immediately become a stakeholder in the Parkinson’s Disease community and through this breakthrough, we are making possible new paradigms for better clinical care, including earlier screening and diagnosis, targeted treatments, and faster, cheaper drug development. This is just the beginning for AXIM in this arena,” Huemoeller noted, adding that the company’s assay has provided “both researchers and clinicians a brand-new tool in the fight against PD.”

In addition, the company noted that additional studies have indicated that total lactoferrin (Lf), an antimicrobial protein that is a component of the immune system, is reduced in patients with PD. Via its DED franchise, AXIM has already developed an Lf test due to its role in protecting eye health. The company noted that this test could be used in conjunction with the new α-synuclein diagnostic.

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