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UCSD Researchers Develop a Wearable Skin Patch That Monitors Blood Pressure, Glucose Levels, and Other Biomarkers in Human Sweat

Skin patch technologies could enable clinical laboratories to monitor patients’ vitals and report to medical professionals in real time

Pathologists and clinical laboratory leaders have read many Dark Daily ebriefings on the development of skin patches over the years that do everything from monitoring fatigue in the military to being a complete lab-on-skin technology. Now, researchers at the University of California San Diego (UCSD) have developed a wearable patch that can monitor cardiovascular signals and other various biochemical levels in the body simultaneously.

The researchers believe there is enormous potential for such a patch in helping patients monitor conditions such as hypertension or diabetes. They also foresee a scenario where the patch could be used in settings where vitals must be constantly monitored. They hope to develop future versions of the patch that can detect more biomarkers within the body.

“This type of wearable would be very helpful for people with underlying medical conditions to monitor their own health on a regular basis,” Lu Yin, a PhD student and co-first author of the study, told New Atlas. “It would also serve as a great tool for remote patient monitoring, especially during the COVID-19 pandemic when people are minimizing in-person visits to the clinic,” she added.

The UCSD researchers published the results of their study in the peer-reviewed journal Nature Biomedical Engineering, titled, “An Epidermal Patch for the Simultaneous Monitoring of Haemodynamic and Metabolic Biomarkers.”

Combining Precision Medicine with Telehealth and the Internet of Things

About the size of a postage stamp and consisting of stretchy polymers that conform to the skin, the UCSD patch monitors blood pressure and contains sensors that measure different biochemical levels in the body, such as:

The sensors are carefully arranged on the patch to eliminate interference between the signals, noted a UCSD press release.

Skin patch monitoring device

In their published research, the UCSD researchers wrote of their new skin patch monitoring device, “Intertwined with concepts of telehealth, the internet of medical things, and precision medicine, wearable sensors offer features to actively and remotely monitor physiological parameters. Wearable sensors can generate data continuously without causing any discomfort or interruptions to daily activity, thus enhancing the self-monitoring compliance of the wearer, and improving the quality of patient care.” (Photo copyright: University of California San Diego.)

“Each sensor provides a separate picture of a physical or chemical change. Integrating them all in one wearable patch allows us to stitch those different pictures together to get a more comprehensive overview of what’s going on in our bodies,” said Sheng Xu, PhD, Principle Investigator, Xu Research Group at UCSD, Assistant Professor in the Department of NanoEngineering Department, and a co-first author of the study, in the press release.

The UCSD researchers developed their skin patch to monitor specific biomarkers that can affect blood pressure.

“Let’s say you are monitoring your blood pressure and you see spikes during the day and think that something is wrong,” co-first author Juliane Sempionatto, PhD, a postdoctoral researcher at California Institute of Technology (Caltech) and co-first author of the study, told New Atlas. “But a biomarker reading could tell you if those spikes were due to an intake of alcohol or caffeine. This combination of sensors can give you that type of information,” she added.

The blood pressure sensor sits near the center of the patch and consists of a set of small transducers welded to the patch via a conductive link. Voltage applied to the transducers send ultrasound waves through the body which bounce off arteries and create echoes that are detected by the sensor and converted into an accurate blood pressure reading.

The chemical sensor releases the drug pilocarpine into the skin to induce sweat and then measures the chemicals contained in the sweat to provide readings of certain biochemical levels.

The glucose sensor located in the patch emits a mild electrical current to the body that stimulates the release of interstitial fluid and then reads the glucose level in that fluid.

Joseph Wang, D.Sc

“The novelty here is that we take completely different sensors and merge them together on a single small platform as small as a stamp,” Joseph Wang, D.Sc, SAIC Endowed Chair, Distinguished Professor of NanoEngineering, Director of the Center for Wearable Sensors at UCSD, and co-author of the study told New Atlas. “We can collect so much information with this one wearable and do so in a non-invasive way, without causing discomfort or interruptions to daily activity.” (Photo copyright: University of Southern California San Diego.)

Skin Patch Measurements Closely Match Those of Traditional Devices

Test subjects wore the patch on their neck while performing various combinations of the following tasks:

  • exercising on a stationary bicycle,
  • eating a high-sugar meal,
  • drinking an alcoholic beverage, and
  • drinking a caffeinated beverage.

The results of the measurements taken from the patch closely matched measurements collected by traditional monitoring devices such as a:

For now, the patch must be connected to an external power source which transmits the reading to a counter-top machine, but the researchers hope to create a wireless version in the future.

“There are opportunities to monitor other biomarkers associated with various diseases,” Sempionatto said in the UCSD press release. “We are looking to add more clinical value to this device.”

Other Similar Skin Patch Monitoring Technologies

Though an important breakthrough, the UCSD’s device is not the first skin patch monitor to be developed.

In “Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid,” Dark Daily reported on a microneedle patch designed by researchers at the McKelvey School of Engineering at Washington University in St. Louis which adheres to the skin like a bandage and could possibly serve as a pain-free way to take blood samples without the need for a venipuncture or needle stick.

And in “In the Field of Nano-Scale Diagnostics, Many Researchers Are Developing ‘Lab-on-Skin’ Technologies That Can Monitor Many Clinical Laboratory Biomarkers,” we covered development of a wearable “lab-on-skin” technology that noninvasively measure a variety of physiological data, including: blood pressure, glucose/potassium/sodium levels, hydration, oxygenation, and more.

Multiple research and clinical studies are underway that hope to prove the accuracy and safety of wearable devices at detecting and monitoring certain health conditions. It’s a worthy goal.

Skin patches, such as the one created at UCSD, could enable clinical laboratories to provide value-added service to medical professionals and patients alike. Medical labs could potentially monitor skin patch readings in real-time and notify physicians and patients of changes in biomarkers that require attention.

Further, as this technology is developed, it will likely find a ready market with the latest generation of consumers who are more willing than previous generations to buy their own diagnostic tests for home use. These “next-generation” healthcare consumers have demonstrated their willingness to use Apple watches, Fitbits, and similar wearable devices to monitor their condition during exercise and other health metrics.

Pathologists and clinical laboratory managers should not overlook the potential for robust consumer demand to accelerate development and market adoption of such skin patches.

JP Schlingman

Related Information

First-of-a-kind Patch Tracks Multiple Biochemicals and Blood Pressure

An Epidermal Patch for the Simultaneous Monitoring of Haemodynamic and Metabolic Biomarkers

New Skin Patch Brings Us Closer to Wearable, All-In-One Health Monitor

Researchers at Washington University in St. Louis Use Microneedle Patch with Fluorescent Nanolabels to Detect Biomarkers in Skin’s Interstitial Fluid

In the Field of Nano-Scale Diagnostics, Many Researchers Are Developing ‘Lab-on-Skin’ Technologies That Can Monitor Many Clinical Laboratory Biomarkers

Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?

Thailand Researchers Train Labrador Retrievers to Detect COVID-19 in Human Sweat

This is yet another example that dogs can be highly accurate screeners for disease. But are they ready to be included in clinical laboratory diagnostic tests?

Thailand researchers have trained dogs to screen for COVID-19 infections in humans, despite the country’s “spicy and flavorful cuisine,” the AP reported. This is just the latest example of a country using dogs to identify individuals who are infected with the SARS-CoV-2 coronavirus. Clinical laboratory managers and pathologists have seen other examples of dogs being trained to identify different diseases or health conditions.

In fact, dogs have been shown to be highly accurate at spotting disease in humans and the practice is becoming common worldwide. But could dogs achieve the required clinical accuracy and reproducibility in detecting disease for the procedure to be translated into clinical practice?

Smelling Disease as a Clinical Laboratory Diagnostic

Clinical laboratory professionals are quite familiar with the concept of the human body producing volatile chemicals that can serve as biomarkers for disease or illness. Dark Daily has previously reported on multiple breath/aroma-based diagnostic clinical laboratory tests going as far back as 2013.

We even reported on a woman in the UK who could smell Parkinson’s Disease in patients long before the appearance of any symptoms.

But it is in the use of dogs to spot COVID-19 infections in humans where this type of breath/aroma-based diagnostic test research is making a notable impact.

In “German Scientists Train Dogs to Detect the Presence of COVID-19 in Saliva Samples; Can a Canine’s Nose Be as Accurate as Clinical Laboratory Testing?” we covered how after only one week of training, dogs in Germany were able to accurately detect the presence of the COVID-19 infection 94% of the time!

“Even if this approach were not warranted as a clinical diagnostic procedure, trained dogs could be deployed at airports, train stations, sporting events, concerts, and other public places to identify individuals who may be positive for SARS-CoV-2, the coronavirus that causes the COVID-19 illness,” we wrote. “Such an approach would make it feasible to ‘screen’ large numbers of people as they are on the move. Those individuals could then undergo a more precise medical laboratory test as confirmation of infections.”

Now, researchers at the Faculty of Veterinary Science at Bangkok’s Chulalongkorn University have successfully trained dogs to sniff out the disease by smelling human sweat samples.

According to the researchers, individuals with a COVID-19 infection emit a unique odor that is present in sweat samples. The six Labrador retrievers used in the research were able to detect the presence of COVID-19 with an impressive 95% accuracy rate in more than 1,000 samples presented to them, the AP reported.

A Labrador Retriever sniffing the COVID-19 Virus

A Labrador Retriever named Bobby (above) sniffs sample of human sweat through containers to detect COVID-19 coronavirus at Veterinary Faculty, Chulalongkorn University in Bangkok. Thailand has deployed a canine virus detection squad to help provide a fast and effective way of identifying people with COVID-19 as the country faces a surge in cases, with clusters found in several crowded slum communities and large markets. Clinical laboratory professionals and pathologists will find it interesting that the dogs are given a sample of sweat, each presented in a unique container. Thus, the dogs never are in the presence of the humans who provided the specimens. (Photo and caption copyright: AP/Sakchai Lalit)

To perform the study, the scientists placed sweat samples in metal containers and allowed the dogs to sniff each sample. If no trace of the infection was present, the dogs simply walked past the container. If the disease was detected in a particular sample, the dogs would sit down in front of the container.

Would Spicy Food Interfere with Dogs’ Ability to Detect COVID-19?

The head of the research team, Professor Kaywalee Chatdarong, PhD, noted that other countries also have been using canines to detect the presence of COVID-19. She did have some concerns that the utilization of dogs for this purpose may not work in Thailand due to their often-spicy cuisine. However, since the samples used were from students and faculty at the university, as well as people from the surrounding area, the cuisine did not seem to affect the study results, the AP reported.

Thailand is facing a surge in COVID-19 cases with recent clusters reported at construction sites, crowded neighborhoods, and large markets. The research team plans to use the canines in mobile units in communities suspected of being hotspots for the disease.

A major plus of using dogs to sniff out the disease from sweat samples is the ability to test people who may not be able to get out of their homes to be tested.

“People can simply put cotton balls underneath their armpits to collect sweat samples and send them to the lab,” Suwanna Thanaboonsombat, a volunteer who collects samples and brings them to the clinical laboratory for testing, told the AP. “And the result is quite accurate.”

According to the US Centers for Disease Control and Prevention (CDC), dogs can become infected with the SARS-CoV-2 coronavirus. However, their chances of transmitting the disease to humans is extremely low. Nevertheless, to ensure the dogs do not become infected with COVID-19 themselves, the researchers designed the sample containers to avoid contact between the samples and the dogs’ noses.

Living Animals Come with Limitations

While dogs can provide a quick and inexpensive method of testing for COVID-19, they do have limitations.

“5 p.m. is their dinner time. When it’s around 4:50, they will start to be distracted. So, you can’t really have them work anymore,” Chatdarong told the AP. “And we can’t have them working after dinner either because they need a nap. They are living animals and we do have to take their needs and emotions into consideration. But for me, they are heroes and heroines.”

Using Dogs to Detect COVID-19 in Other Countries

Last fall, the Helsinki Airport in Finland announced it would use a team of trained dogs to detect the presence of COVID-19 among visitors to the airport to ensure the health and safety of its customers and their families, and to help prevent the spread of SARS-CoV-2 in Finland.

Working dog in Finland

Being tested for the coronavirus at the Helsinki airport in Finland does not require direct contact with a dog. Individuals simply need to swipe their skin with a test wipe and drop the wipe into a cup. The cup is then given to a dog that is working in a separate booth (shown above), which protects both the dog and the dog’s handler from contamination. All tests are processed anonymously and anyone testing positive for COVID-19 is directed to a health information point located at the airport. (Photo copyright: Finavia.)

“We are among the pioneers. As far as we know no other airport has attempted to use canine scent detection on such a large scale against COVID-19,” said Airport Director Ulla Lettijeff in a Finavia press release. “This might be an additional step forward on the way to beating COVID-19.”

In addition to being “man’s best friend,” dogs serve valuable purposes in the medical community. Their strong sense of smell may render them useful in the detection of and fight against illnesses, including COVID-19.

Whether the performance and accuracy of individual dogs can be validated with acceptable quality control (QC) procedures remains to be seen. Medical laboratory managers and pathologists understand the challenges presented with demonstrating accuracy and reproducibility with this method of diagnostic testing. That obstacle has prevented research outcomes from being translated into clinical practice.

JP Schlingman

Related Information

Sniffing Labrador Retrievers Join Thai Coronavirus Fight

Sniffing Dogs Join Coronavirus Fight in Various Studies and Trial Programs

COVID-19 Dogs Arrive at the Airport—Able to Identify the Virus Earlier than Laboratory Tests

Coronavirus Disease 2019 (COVID-19) Factsheet: What You Need to Know about COVID-19 and Pets

Trained on Smelly Socks, Bio-Detection Dogs Sniff Out COVID-19

Switzerland Trains Sniffer Dogs for Detecting COVID-19

Dogs in Germany Trained to Sniff Out COVID-19 in Humans, Researchers Say

German Scientists Train Dogs to Detect the Presence of COVID-19 in Saliva Samples; Can a Canine’s Nose Be as Accurate as Clinical Laboratory Testing?

Woman Who Can Smell Parkinson’s Disease in Patients Even Before Symptoms Appear May Help Researchers Develop New Clinical Laboratory Test

C. diff-sniffing Beagle Dog Could Lead to Better Infection Control Outcomes in Hospitals and Nursing Homes

WHO Expands TB Diagnostic Toolkit with Point-of-Care Tests, Tongue Swabs, and Sample Pooling

WHO introduces faster, more accessible TB testing strategies while CDC maintains a targeted, risk-based approach in the United States.

The World Health Organization (WHO) has issued new recommendations aimed at improving access to faster, more efficient tuberculosis (TB) diagnostics by introducing near point-of-care molecular testing, alternative sample collection methods, and pooled testing strategies, according to a news release.

For the first time, WHO is recommending a new class of near point-of-care nucleic acid amplification tests (NPOC-NAATs) that can be deployed in decentralized settings such as primary care clinics and community health centers. These systems are designed to deliver faster results at lower cost compared to traditional laboratory-based molecular platforms, potentially shifting more TB testing closer to the patient.

Clinical laboratory scientists should note that the WHO’s guidelines diverge noticeably from those of the Centers for Disease Control and Prevention (CDC).

The updated guidance also endorses tongue swabs as an alternative specimen type for TB detection, particularly for patients unable to produce sputum. In parallel, WHO recommends sputum pooling as a strategy to improve efficiency and reduce costs, allowing laboratories to increase throughput while conserving reagents in resource-constrained environments.

“These new WHO recommendations mark a major step forward in making TB testing faster and more accessible,” said Tereza Kasaeva, director of WHO’s Department for HIV, TB, Hepatitis & STIs. “WHO urges countries and partners to work together to roll out these guidelines to close persistent diagnostic gaps and ensure that everyone with TB can be diagnosed early and start life-saving treatment without delay.” (Photo credit: WHO)

The recommendations arrive as global diagnostic gaps persist despite international commitments to expand access to rapid molecular testing. Many patients still experience delays due to reliance on sputum samples, centralized laboratory infrastructure, and the high cost of testing platforms.

New WHO Recommendations Emphasize Access and Efficiency

WHO’s updated Module 3: Diagnosis guidelines, expected later this year, reflect a broader shift toward decentralization and scalability in TB diagnostics.

By enabling testing at peripheral healthcare levels, the new NPOC-NAAT systems could reduce turnaround times and expand access in underserved regions. Tongue swabs further simplify sample collection, while pooling strategies offer laboratories a practical way to stretch limited resources without sacrificing diagnostic reach.

Supporting materials, including an operational handbook and implementation toolkit, will guide laboratories and national TB programs through adoption, training, and workflow integration.

CDC Maintains Targeted Testing Approach in the US

In contrast to WHO’s global push for expanded access, the CDC continues to emphasize a targeted testing strategy for tuberculosis in the United States, focusing on high-risk individuals rather than universal screening.

TB case counts and rates have been increasing since 2021, the CDC noted in late 2025. The US saw a 7.9% increase in case count and a 6.9% increase in rate in 2024 as compared to a year earlier. In 2024, there were 10,388 TB cases in the US with a corresponding incidence rate of 3.1 per 100,000 population.

Two Types of TB Infection Tests

The CDC recognizes two primary methods to detect TB infection, though neither distinguishes between latent infection and active disease:

  • TB blood tests: Preferred for most individuals, particularly those vaccinated with Bacille Calmette-Guérin (BCG). (BCG is primarily used to prevent severe childhood TB particularly in high-prevalence countries. BCG is generally not recommended in the US.)
  • TB skin test: Still used in certain cases, especially for children under age five, and for baseline testing scenarios requiring a two-step approach.

Five Components of a Full Diagnostic Evaluation

If a patient tests positive or presents symptoms such as chronic cough, night sweats, or weight loss, the CDC recommends a comprehensive evaluation that includes:

  • Medical history and risk assessment
  • Physical examination
  • Chest X-ray
  • Bacteriologic testing using sputum samples (typically three), including:
    • NAAT for rapid detection
    • Sputum smear microscopy
    • Culture
    • Drug susceptibility testing to guide treatment decisions

Updated Guidance for Healthcare Personnel

Recent CDC guidance, developed with the National Tuberculosis Controllers Association, reflects a shift in screening practices for healthcare workers:

  • Baseline TB testing is required upon hire
  • Routine annual testing is no longer recommended for most healthcare workers
  • Post-exposure testing is advised immediately and again eight to 10 weeks later if initial results are negative

For 2026, the CDC emphasizes several important nuances for clinicians and laboratories interpreting TB test results. Blood-based interferon-gamma release assays (IGRAs) are strongly preferred for individuals who have received the BCG vaccine, as they are less likely to produce false-positive results compared to skin tests. In addition, for individuals considered low risk for TB, a positive result should be confirmed with a second test—ideally using a different method—before treatment is initiated, helping to avoid unnecessary therapy and ensure diagnostic accuracy.

Implications for Clinical Laboratories

Together, WHO and CDC guidance illustrate a divergence in strategy shaped by global versus domestic needs. WHO’s recommendations prioritize expanded access, decentralization, and cost efficiency—particularly in high-burden or resource-limited settings—while CDC guidance reflects a more targeted, risk-based approach within a lower-incidence environment.

For clinical laboratories, the evolving landscape signals both opportunity and complexity: Adoption of decentralized molecular platforms, validation of alternative specimen types, and optimization of high-throughput workflows such as pooling may become increasingly important as TB diagnostic strategies continue to evolve.

This article was created with the assistance of Generative AI and has undergone editorial review before publishing.

—Janette Wider

Kansas City Tuberculosis Outbreak One of the Largest in History

Hospital laboratories are likely to see an increase in test orders for bacteria-borne infections, such as tuberculosis

The tuberculosis outbreak in Kansas City, Kan., is one of the largest in the US within a one-year period over the past several decades. Hospital laboratories are the front line for detecting these types of infectious diseases.

As of June 6, 2025, the number of reported active cases of tuberculosis (TB) since 2024 was 69 with 62 cases in Wyandotte County and seven cases in nearby Johnson County, both in Kansas, according to the latest available data as of this writing from the Kansas Department of Health and Environment.

An active TB infection is one in which patients are symptomatic, in need of immediate treatment, and contagious. These patients have typically had a positive TB blood or skin test and may have had an abnormal chest x-ray or positive sputum smear or culture.

The latest statistics show there are 97 cases of latent TB infections reported in the same counties. Latent TB infections are those where patients are asymptomatic but have had a positive TB test, a normal chest x-ray, and a negative sputum smear.

Although individuals with latent infections cannot transmit the illness to others, these cases may become active without treatment, rendering them potentially dangerous.

“You can think of TB outbreaks like a canary in the coalmine of our public health infrastructure,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “What causes them to happen is a weakening of our public health infrastructure.” (Photo copyright: Johns Hopkins Medicine.)

Cause of Outbreak Remains Unknown

This TB outbreak was first identified in Kansas last year and its origin is unknown. Two people have died from the infection, but the risk to the public remains low.

“It’s definitely more than just a little blip,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “It’s one of the largest outbreaks of tuberculosis that we’ve seen in the country in the past 30, 40, 50 years.”

TB in humans can be caused by two types of mycobacteria: Mycobacterium tuberculosis and Mycobacterium bovis. The former is the most common cause of the disease. The pathogen is airborne and is transmitted via respiratory droplets produced by coughing, sneezing, or speaking. 

TB usually attacks the lungs, but other parts of the body can be affected as well. According to the Centers for Disease Control and Prevention, symptoms of the disease include:

  • Cough that lasts more than three weeks.
  • Coughing up blood or sputum.
  • Fever and chills.
  • Loss of appetite.
  • Weight loss.
  • Night sweats.
  • Weakness or fatigue.
  • Chest pains.

Each patient in the Kansas outbreak has been screened and contact traced. Testing is being provided free of charge. TB is treatable via antibiotics, and more than 85% of infected individuals fully recover with treatment.

TB is Relatively Common

Although curable and preventable, TB is one of the world’s deadliest infectious diseases. According to the World Health Organization, an estimated 10.8 million people contracted TB in 2023, and 1.25 million people died from the disease that year. Fewer than 10,000 of the cases occurred in the US.

“I think the first misconception about TB is that it’s a rare and uncommon disease. We think of it as something that doesn’t really impact us anymore in 2025, but TB has been here, is here, and it’s something that’s relatively common,” said Michael Bernstein, MD, director of pulmonary and critical care at Stamford Health, Stamford, Conn., in the American Journal of Managed Care. “So, the fact that we would see a TB outbreak doesn’t surprise most pulmonologists.”

Clinical laboratories should monitor localized TB outbreaks as they are at the forefront for testing and detecting infectious diseases. Hospital labs may want to prepare for an upsurge in patients arriving with tuberculosis and other bacterial infections in the future.        

—JP Schlingman

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

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