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Clinical Laboratories and Pathology Groups

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AXIM Biotechnologies Develops Diagnostic Test for Parkinson’s Disease That Uses Tear Drop Specimens and Returns Results in Less than 10 Minutes at the Point of Care

New non-invasive test could replace traditional painful spinal taps and clinical laboratory fluid analysis for diagnosis of Parkinson’s disease

Scientists at AXIM Biotechnologies of San Diego have added another specimen that can be collected non-invasively for rapid, point-of-care clinical laboratory testing. This time it is tears, and the diagnostic test is for Parkinson’s disease (PD).

The new assay measures abnormal alpha-synuclein (a-synuclein), a protein that is a biomarker for Parkinson’s, according to an AXIM news release which also said the test is the first rapid test for PD.

“The revolutionary nature of AXIM’s new test is that it is non-invasive, inexpensive, and it can be performed at a point of care. It does not require a lumbar puncture, freezing, or sending samples to a lab. AXIM’s assay uses a tiny tear drop versus a spinal tap to collect the fluid sample and the test can be run at a doctor’s office with quantitative results delivered from a reader in less than 10 minutes,” the news release notes.

A recent study conducted by the Michael J. Fox Foundation for Parkinson’s Research published in The Lancet Neurology titled, “Assessment of Heterogeneity among Participants in the Parkinson’s Progression Markers Initiative Cohort Using Α-Synuclein Seed Amplification: A Cross-Sectional Study,” found that “the presence of abnormal alpha-synuclein was detected in an astonishing 93% of people with Parkinson’s who participated in the study,” the news release noted.

“Furthermore, emerging evidence shows that a-synuclein assays have the potential to differentiate people with PD from healthy controls, enabling the potential for early identification of at-risk groups,” the news release continues. “These findings suggest a crucial role for a-synuclein in therapeutic development, both in identifying pathologically defined subgroups of people with Parkinson’s disease and establishing biomarker-defined at-risk cohorts.”

This is just the latest example of a disease biomarker that can be collected noninvasively. Other such biomarkers Dark Daily has covered include:

“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,” said John Huemoeller, CEO, AXIM (above), in a news release. Patients benefit from non-invasive clinical laboratory testing. (Photo copyright: AXIM Biotechnologies.)

Fast POC Test versus Schirmer Strip

AXIM said it moved forward with its novel a-synuclein test propelled by earlier tear-related research that found “a-synuclein in its aggregated form can be detected in tears,” Inside Precision Medicine reported.

But that research used what AXIM called the “outdated” Schirmer Strip method to collect tears. The technique involves freezing tear samples at -80 degrees Celsius (-112 Fahrenheit), then sending them to a clinical laboratory for centrifugation for 30 minutes; quantifying tear protein content with a bicinchoninic acid assay, and detecting a-synuclein using a plate reader, AXIM explained.

Alternatively, AXIM says its new test may be performed in doctors’ offices and offers “quantitative results delivered from a reader in less than 10 minutes.”

“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, CEO, AXIM in the news release.

“This is just the beginning for AXIM in this arena,” he added. “But 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 research, enabling both researchers and clinicians a brand-new tool in the fight against PD.”

AXIM acquired Advanced Tear Diagnostics, Birmingham, Ala., in 2021. As part of this acquisition, it obtained two US Food and Drug Administration-cleared tests for dry eye syndrome, Fierce Biotech reported.

One of those tests was “a lateral flow diagnostic for point-of-care use that measures the level of lactoferrin proteins in tear fluid, which work to protect the surface of the eye. … Axim said that low lactoferrin levels have also been linked to Parkinson’s disease and that the assay can be used alongside its alpha-synuclein test,” Fierce Biotech noted.

Why Tears for PD Test?

Mark Lew, MD, Professor of Clinical Neurology, University of Southern California Keck School of Medicine, published earlier studies about using tear samples as biomarkers for Parkinson’s disease.

“It made sense to try and look at the proteinaceous [consisting of or containing protein] constituents of tear fluid,” Lew told Neurology Live. “Tear fluid is easy to collect. It’s noninvasive, inexpensive. It’s not like when you do a lumbar puncture, which is a much more involved ordeal. There’s risk of contamination with blood (saliva is dirty) issues with blood and collection. [Tear fluid analysis] is much safer and less expensive to do.”

In Biomarkers in Medicine, Lew et al noted why tears make good biomarkers for Parkinson’s disease, including “the interconnections between the ocular [eye] surface system and neurons affected in Parkinson’s disease.”

The researchers also highlighted “recent data on the identification of tear biomarkers including oligomeric α-synuclein, associated with neuronal degeneration in PD, in tears of PD patients” and discussed “possible sources for its release into tears.”

Future Clinical Laboratory Testing for Parkinson’s

Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s. It affects nearly one million people in the US. About 1.2 million people may have it by 2030, according to the Parkinson’s Foundation.

Thus, an accurate, inexpensive, non-invasive diagnostic test that can be performed at the point of care, and which returns clinical laboratory test results in less than 10 minutes, will be a boon to physicians who treat PD patients worldwide.

Clinical laboratory managers and pathologists may want to follow AXIM’s future research to see when the diagnostic test may become available for clinical use.

—Donna Marie Pocius

Related Information:

Parkinson’s Disease Biomarker Found

AXIM Biotechnologies Develops First Non-Invasive, Rapid, Point-of-Care, Diagnostic Test for Parkinson’s Disease

Assessment of Heterogeneity Among Participants in the Parkinson’s Progression Markers Initiative Cohort Using A-Synuclein Seed Amplification: a Cross-sectional Study

Tear Drop Test is First Rapid, Point-of-Care Diagnostic for Parkinson’s Disease

New Test Aims to Spot Signs of Parkinson’s Disease within a Tear Drop

Motivations for Using Tears to Confirm Parkinson’s Disease Diagnosis

Tears—More to Them than Meets the Eye: Why Tears are a Good Source of Biomarkers in Parkinson’s Disease

University of Pennsylvania Researchers Use Cellulose to Produce Accurate Rapid COVID-19 Test Results Faster and Cheaper than Traditional PCR Tests

Researchers are working to create accurate rapid COVID-19 tests with lower costs and less waste than existing rapid clinical laboratory tests

University of Pennsylvania (UPenn) researchers have developed a biodegradable rapid COVID-19 test that raises the bar on traditional polymerase chain reaction (PCR) tests, which throughout the COVID-19 pandemic have been the gold standard for SARS-CoV-2 diagnostic testing.

Many clinical laboratory professionals are aware of the significant amount of waste going into landfills from spent COVID-19 rapid PCR tests that use biosensors to produce results. These biosensor systems “use printed circuit boards, or PCBs, the same materials used in computers. PCBs are difficult to recycle and slow to biodegrade, using large amounts of metal, plastic, and non-eco-friendly materials,” according to a Penn Engineering Today blog post.

UPenn’s new test does not use PCBs. Instead, its biosensor uses “bacterial cellulose (BC), an organic compound synthesized from several strains of bacteria,” the blog post noted.

“This new BC test is non-toxic, naturally biodegradable and both inexpensive and scalable to mass production, currently costing less than $4.00 per test to produce. Its cellulose fibers do not require the chemicals used to manufacture paper, and the test is almost entirely biodegradable,” the blog post continued.

The Penn engineers published their findings in the journal Cell Reports Physical Science titled, “A Bacterial Cellulose-Based and Low-Cost Electrochemical Biosensor for Ultrasensitive Detection of SARS-CoV-2.”

Cesar de la Fuente, PhD

“There is a need for biodegradable diagnostic testing,” said Cesar de la Fuente, PhD (above), Presidential Assistant Professor in the Psychiatry Department at the University of Pennsylvania’s Perelman School of Medicine. “We will be continuing to perfect this technology, which could hopefully help many people in the future, while also looking to expand it to other emerging pathogens in anticipation of future pandemics.” Clinical laboratories engaged in SARS-CoV-2 testing during the COVID-19 pandemic can attest to the massive amounts of waste generated by traditional PCR testing. (Photo copyright: University of Pennsylvania.)

Evolution of Improvement for SARS-CoV-2 Diagnostic Assays

Cesar de la Fuente, PhD, is Presidential Assistant Professor in the Psychiatry Department at the Perelman School of Medicine. His lab has been hard at work since the start of the pandemic to improve COVID-19 testing. The recent study was a collaboration between University of Pennsylvania’s de la Fuente Lab and William Reis de Araujo, Professor in Analytical Chemistry at the State University of Campinas (UNICAMP) in São Paulo, Brazil.

De Araujo leads the Portable Chemical Sensors Lab and has been pairing his electrochemistry expertise with de la Fuente’s lab for years, Penn Engineering Today noted.

The team wanted to combine the speed and cost-effectiveness of previous rapid tests with an eco-friendly biodegradable substrate material.

Bacterial cellulose (BC) was a great choice because it “naturally serves as a factory for the production of cellulose, a paper-like substance which can be used as the basis for biosensors,” Penn Engineering Today reported.

Additionally, BC has an excellent track record for a variety of uses, such as regenerative medicine, wound care, and point-of-care (POC) diagnostics, the blog post noted. UPenn’s test offers speed and accuracy without needing costly equipment making it desirable for clinical laboratories preparing to fight the next pandemic.

The test has shown to be capable of “correctly identifying multiple variants in under 10 minutes. This means that the tests won’t require ‘recalibration’ to accurately test for new variants,” Penn Engineering Today added.

Innovation Born from Inspiration

Though rapid tests are essential to help curb the spread of COVID-19, the negatives that come with these tests didn’t sit well with the UPenn team. This spurred them to strive for improvements.

PCR tests “are hampered by waste [metal, plastic, and the aforementioned PCBs]. They require significant time [results can take up to a day or more] as well as specialized equipment and labor, all of which increase costs,” Penn Engineering Today noted.

Additionally, “Sophistication of PCR tests makes them harder to tweak and therefore slower to respond to new variants,” the blog post concluded.

“There’s a tension between these two worlds of innovation and conservation,” de la Fuente told Penn Engineering Today. “When we create new technology, we have a responsibility to think through the consequences for the planet and to find ways to mitigate the environmental impact.” 

Need for Biodegradable Diagnostic Tests

“COVID-19 has led to over 6.8 million deaths worldwide and continues to affect millions of people, primarily in low-income countries and communities with low vaccination coverage,” the Cell Reports Physical Science paper noted.

“There is a need for biodegradable diagnostic testing,” de la Fuentes told Penn Engineering Today. “We will be continuing to perfect this technology, which could hopefully help many people in the future, while also looking to expand it to other emerging pathogens in anticipation of future pandemics.”

While UPenn’s test will require clinical trials and FDA approval before it can become available to clinical laboratories and for point-of-care testing, it promises a bright, eco-friendly future for rapid viral testing.

—Kristin Althea O’Connor

Related Information:

Penn Engineers Create Low-Cost, Eco-Friendly COVID Test

A Bacterial Cellulose-Based and Low-Cost Electrochemical Biosensor for Ultrasensitive Detection of SARS-CoV-2

Rapid COVID-19 Diagnostic Test Delivers Results within Four Minutes with 90% Accuracy

Penn Researchers Develop Faster, Biodegradable COVID-19 Tests

Penn Medicine Researchers Develop Fast, Accurate, Inexpensive COVID-19 Diagnostic Test Based on Electrochemical Technology

Clinical Pathology Laboratory Leaders Reported Big Savings from Cost-Cutting Programs during Last Week’s Lab Quality Confab

A sold-out audience gathered at the seventh annual Lab Quality Confab and heard speakers from the nation’s most innovative medical laboratories share case studies about success in cutting lab expenses and improving quality

DATELINE: NEW ORLEANS, LOUISIANA—At a time when medical laboratories in the United States are experiencing significant financial challenges, there was plenty of guarded optimism among the clinical laboratory managers and pathologists who gathered in this famous city last week for the seventh annual Lab Quality Confab.

One reason for this optimism is that speakers and attendees at this sold-out meeting are the nation’s leading experts in the use of Lean, Six Sigma, and process improvement methods in medical laboratories and pathology groups. They know how to cut lab costs while maintaining quality and boosting the productivity of the lab’s staff and automated systems. (more…)

MinuteClinic Gains Contract to Offer New Rapid Test for Conjunctivitis

Early example of how in-store walk-up clinics may expand their lab testing services

Pathologists concerned that in-store walk-up clinics might become important laboratory testing centers will be interested to learn about the latest development. The largest operator of these in-store clinics has just partnered with an in vitro diagnostics (IVD) manufacturer for exclusive access to a new rapid diagnostic test.

MinuteClinic, the pioneer and largest operator of in-store health clinics, has a deal with Rapid Pathogen Screening, Inc. (RPS), a Sarasota, Fla.-based biotechnology company, to offer the RPS Adeno Detector test for conjunctivitis, or pink eye. This new point-of-care (POC) test will be initially offered at the MinuteClinics located in 23 CVS pharmacy stores in the Atlanta area.

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