Axim develops quick teardrop test that may aid Parkinson’s diagnosis

The assay can detect toxic clumps of the alpha-synuclein protein, company said

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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Axim Biotechnologies has developed an assay to detect toxic clumps of the alpha-synuclein protein, a known biomarker of Parkinson’s disease, from a single teardrop.

The company believes the noninvasive test, which can be run at the doctor’s office and provides faster results than other tear tests, could help diagnose the neurodegenerative disease.

“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,” John Huemoeller II, Axim CEO, said in a company press release. “I am convinced when pharmaceutical companies, foundations, and neurologists see how our solution can better help diagnose Parkinson’s Disease in such an expedited and affordable way, we will be at the forefront of PD [Parkinson’s disease] research, enabling both researchers and clinicians a brand-new tool in the fight against PD.”

In Parkinson’s, a misfolded version of the alpha-synuclein protein accumulates abnormally, forming toxic clumps that disrupt nerve cell function and contribute to neurodegeneration.

For this reason, measuring alpha-synuclein aggregates is thought to be able to help diagnose the disease or identify those at risk for it, thereby enabling an earlier start to treatment. These aggregates also accumulate in other conditions so quantifying them alone isn’t enough for a Parkinson’s diagnosis, but it can help doctors to hone in on a diagnosis.

The most well-validated way of doing this is by measuring the protein in the cerebrospinal fluid (CSF) that surrounds the brain and spinal cord. Indeed, a study from the Michael J. Fox Foundation for Parkinson’s Research showed a CSF test for abnormal alpha-synuclein was highly accurate at detecting Parkinson’s. The test positively identified more than 90% of Parkinson’s patients with very few false positives.

CSF collection is an invasive process, however, and involves inserting a needle into the space between the spinal vertebrae, so less invasive tests to detect alpha-synuclein aggregates are desired.

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Tears May Be Used as Biological Marker to Detect Parkinson’s Disease

Alpha-synuclein in teardrops

Research has shown alpha-synuclein clumps can be detected in tears, and that they’re present at higher levels in Parkinson’s patients relative to healthy people. This suggest that measuring alpha-synuclein aggregates in teardrops may be a noninvasive way to diagnose Parkinson’s.

Earlier approaches to collect and analyze tear samples were time-consuming and difficult, however, requiring that they be frozen and sent to a lab for analysis, according to Axim, which believes its new point-of-care test offers a faster and easier way to measure alpha-synuclein in tear samples. It can be run directly at a doctor’s office and results are available in less than 10 minutes.

No data on the test’s accuracy at discriminating between Parkinson’s patients and people without the disease were provided by Axim.

It isn’t yet known how alpha-synuclein measurements in the CSF correlate with levels of the protein in tears. Research is also underway to develop tests for detecting abnormal alpha-synuclein from blood samples and from nasal swabs and skin samples. More work is likely needed to understand the association between alpha-synuclein levels in different bodily fluids or tissues and to validate the use of these various assays in the clinic.

Axim markets a tear test that measures levels of lactoferrin, an iron-binding protein that helps balance iron levels in the body and is a biomarker of dry-eye disease. Evidence indicates lactoferrin is neuroprotective, and may be dysregulated in Parkinson’s.

Axim believes its alpha-synuclein test could eventually be used with the lactoferrin assay to provide a more accurate diagnosis of the neurodegenerative disease.

“Our proven expertise in developing tear-based diagnostic tests has led to the development of this [alpha-synuclein] 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,” Huemoeller said.