News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

German Researchers Create Non-invasive Lab-on-a-Chip Biosensor That Detects Antibiotic Levels from Breath Samples

Should the device prove effective, it could replace invasive point-of-care blood draws for clinical laboratory testing during patient drug therapy monitoring

What if it were possible to perform therapeutic drug monitoring (TDM) without invasive blood draws using breath alone? Patients fighting infections in hospitals certainly would benefit. Traditional TDM can be a painful process for patients, one that also brings risk of bloodline infections. Nevertheless, regular blood draws have been the only reliable method for obtaining viable samples for testing.

One area of critical TDM is in antibiotic therapy, also known as personalized antibiotherapy. However, for antibiotic therapy to be successful it typically requires close monitoring using point-of-care clinical laboratory testing.

Now, a team of engineers and biotechnologists from the University of Freiburg in Germany have developed a biosensor that can use breath samples to measure antibiotic concentrations present in blood, according to a University of Freiburg press release.

The team’s non-invasive collection method requires no needle sticks and can allow for frequent specimen collections to closely monitor the levels of an antibiotic prescribed for a patient. The biosensor also provides physicians the ability to tailor antibiotic regimens specific to individual patients, a core element of precision medicine.

The researchers published their findings in the journal Advanced Materials, titled, “Biosensor-Enabled Multiplexed On-Site Therapeutic Drug Monitoring of Antibiotics.”

Can Dincer, PhD
 
“Until now researchers could only detect traces of antibiotics in the breath,” said Can Dincer, PhD (above), Junior Research Group Leader at the University of Freiburg, and one of the authors of the study, in the press release. “With our synthetic proteins on a microfluid chip, we can determine the smallest concentrations in the breath condensate and [how] they correlate with the blood values.” Should the breath biosensor prove effective in clinical settings, painful blood draws for clinical laboratory testing at the point of care could become obsolete. (Photo copyright: Conny Ehm/University of Freiburg.)

Can a Breath Biosensor Be as Accurate as Clinical Laboratory Testing?

The University of Freiburg’s biosensor is a multiplex, microfluid lab-on-a-chip based on synthetic proteins that react to antibiotics. It allows the simultaneous measurement of several breath samples and test substances to determine the levels of therapeutic antibiotics in the blood stream.

To perform their research, the University of Freiburg team tested their biosensor on blood, plasma, urine, saliva, and breath samples of pigs that had been given antibiotics. The results the researchers achieved with their device using breath samples were as accurate as standard clinical laboratory testing, according to the press release.

The microfluidic chip contains synthetic proteins affixed to a polymer film via dry film photoresist (DFR) technology. These proteins are similar to proteins used by drug-resistant bacteria to sense the presence of antibiotics in their environment. Each biosensor contains an immobilization area and an electrochemical cell which are separated by a hydrophobic stopping barrier. The antibiotic in a breath sample binds to the synthetic proteins which generates a change in an electrical current. 

“You could say we are beating the bacteria at their own game,” said Wilfried Weber, PhD, Professor of Biology at the University of Freiburg and one of the authors of the research paper, in the press release.

Rapid Monitoring at Point-of-Care Using Breath Alone

The biosensor could prove to be a useful tool in keeping antibiotic levels stable in severely ill patients who are dealing with serious infections and facing the risk of sepsis, organ failure, or even death. Frequent monitoring of therapeutic antibiotics also could prevent bacteria from mutating and causing the body to become resistant to the medications.

“Rapid monitoring of antibiotic levels would be a huge advantage in hospital,” said H. Ceren Ates, PhD, scientific researcher at the University of Freiburg and one of the authors of the study in the press release. “It might be possible to fit the method into a conventional face mask.”

Along those lines, the researchers are also working on a project to create wearable paper sensors for the continuous measurement of biomarkers of diseases from exhaled breath. Although still in the development stages, this lightweight, small, inexpensive paper sensor can fit into conventional respiratory masks, according to a University of Freiburg press release.

Other Breath Analysis Devices Under Development

Devices that sample breath to detect biomarkers are not new. Dark Daily has regularly reported on similar developments worldwide.

In “NIST Scientists Enhance Frequency Comb Breathalyzer Enabling It to Detect Multiple Disease Biomarkers,” we reported on research conducted at JILA, a research center jointly operated by the National Institutes of Standards and Technology (NIST) and the University of Colorado Boulder, that could pave the way for real-time, noninvasive breath analysis to detect and monitor diseases, and potentially eliminate the need for many blood-based clinical laboratory tests.

And in “Will Blowing in a Device Be Useful in Screening for COVID-19? FDA Grants Its First EUA for a Breathalyzer SARS-CoV-2 Screening Test,” Dark Daily covered the FDA’s first ever emergency use authorization (EUA) for a portable breath test device designed to screen for SARS-CoV-2 infection. Developed by InspectIR Systems, the COVID-19 Breathalyzer identifies a chemical signature associated with SARS-CoV-2 in about three minutes with 91.2% sensitivity and 99.3% specificity.

Thus, University of Freiburg’s non-invasive lab-on-a-chip biosensor is worth watching. More research is needed to validate the effectiveness of the biosensor before it could be employed in hospital settings, however, monitoring and managing antibiotic levels in the body via breath samples could prove to be an effective, non-invasive method of providing personalized antibiotic therapy to patients.

Clinical trials on human breath samples are being planned by the University of Freiburg team. This type of precision medicine service may give medical professionals the ability to maintain proper medication levels within an optimal therapeutic window.

JP Schlingman

Related Information:

Antibiotic Levels Measurable in Breath for the First Time

Biosensor-Enabled Multiplexed On-Site Therapeutic Drug Monitoring of Antibiotics

A Breath of Fresh Information

NIST Scientists Enhance Frequency Comb Breathalyzer Enabling It to Detect Multiple Disease Biomarkers

Will Blowing in a Device Be Useful in Screening for COVID-19? FDA Grants Its First EUA for a Breathalyzer SARS-CoV-2 Screening Test

Disease Investigators Track a Growing Number of Pediatric Hepatitis Cases Appearing Around the World

CDC asks physicians and clinical laboratories to be on the lookout and report symptoms of hepatitis to state health departments

Growing incidences of hepatitis in children are perplexing medical professionals and researchers in several countries around the world. The mysterious outbreak is occurring in otherwise healthy children and, to date, is of unknown origin, though an adenovirus may be involved.

Microbiologists and clinical laboratory scientists who perform virology testing may want to prepare for increased numbers of children presenting with hepatitis symptoms in the US.

On April 21, the Centers for Disease Control and Prevention (CDC) issued a nationwide health alert to notify the public about a cluster of children in Alabama who presented with hepatitis and adenovirus infections. The CDC asked physicians to watch for symptoms in children and to inform local and state health departments of any new suspected cases. 

Also in April, the World Health Organization (WHO) issued its own alert to an outbreak of acute hepatitis of unknown etiology among young children in several countries. In addition to the United States, cases were reported in the United Kingdom, Spain, Israel, Denmark, Ireland, the Netherlands, Italy, Norway, France, Romania, and Belgium.

All the cases reported to the WHO involved children between one month and 16 years of age with the majority of cases occurring in children under five.

According to NBC News, as of May 19, the worldwide number of cases “under investigation” had reached 600 in more than 25 countries. In the US, more than 90% of the patients required hospitalization and 14% of those patients needed a liver transplant. The CDC is investigating five pediatric deaths that may be attributed to the mysterious hepatitis outbreak. 

Jay Butler, MD
 
“Fifteen days ago, CDC issued a nationwide health alert to notify clinicians and public health authorities about an investigation involving nine children in Alabama identified between October of 2021 and February of 2022 with hepatitis or inflammation of the liver and adenovirus infection,” said pediatrician and epidemiologist Jay Butler, MD (above), Deputy Director for Infectious Diseases at the CDC. “We’re casting a broad net to increase our understanding,” he added. “As we learn more, we’ll share additional information and updates.” Hospital-based clinical laboratories that support emergency departments and urgent care centers with testing for hepatitis will want to monitor for upcoming CDC alerts. (Photo copyright: John Amis/AP/CNN.)

Adenovirus/SARS-CoV-2 May Be Linked to Hepatitis Outbreak

The cause of the hepatitis outbreak is as yet undetermined, but the pre-eminent theory among disease experts points to the presence of an adenovirus, which often causes cold and flu-like symptoms in addition to stomach issues. 

NBC News reported that more than half of the US patients, 72% of the UK patients, and 60% of the affected patients across Europe tested positive for human adenovirus type 41. This virus, however, is generally not associated with hepatitis in healthy children, and rarely impacts the liver so severely. 

Medical experts are also considering the possibility that COVID-19 infections could somehow be an underlying cause since the hepatitis outbreak occurred during the pandemic. The WHO is investigating whether exposure to the SARS-CoV-2 coronavirus might have prompted the immune systems in the infected children to react abnormally to adenoviruses that are typically non-life threatening. 

“The big focus over the next week is really looking at the serological testing for previous exposure and infections with COVID,” Phillipa Easterbrook, MD, a senior scientist at the WHO headquarters in Geneva, told NBC News.

Hepatitis, or inflammation of the liver, is typically caused by heavy alcohol use, exposure to toxins, certain medical conditions and medications, or a virus.

According to the CDC, symptoms of hepatitis include:

  • Fever
  • Fatigue
  • Loss of appetite
  • Nausea
  • Vomiting
  • Abdominal pain
  • Dark urine
  • Light-colored stools
  • Joint pain
  • Jaundice

The most recent children diagnosed with hepatitis presented with some or most of these symptoms, particularly stomach issues and fatigue. However, one symptom was present in all the children.

“The big symptom that made all of these kids different was that they all showed signs of jaundice, which is the yellowish coloration of the skin and eyes,” Markus Buchfellner, MD, a pediatric infectious disease fellow at the University of Alabama, told NBC News.

Buchfellner was the first person in the US to notice an unusual pattern of hepatitis among children. He reported his findings to the CDC last fall in 2021.

“We were able to uncover the possible association with the adenovirus 41 strain because it is our standard practice to screen patients diagnosed with hepatitis for adenovirus,” he said. “For us to dig deeper into this medical mystery and see if this strain is the cause of these severe hepatitis cases, we first need more data on how widespread the outbreak is.”

Adenovirus 41 is usually spread through fecal matter, which makes hand washing critical, especially after visits to the bathroom or diaper changes. This type of adenovirus typically presents as diarrhea, vomiting, and fever, and is often accompanied by respiratory issues.

Clinical Labs Performing Gene Sequencing Can Help

Medical scientists around the world are responding to this threat to the youngest and most vulnerable among us. Research is underway into identifying additional cases, determining what is causing the hepatitis globally among children, and establishing preventative measures.

Pathologists and clinical laboratory managers in the US will want to be on the alert for positive hepatitis tests in children whose specimens were tested at their facilities. With advances in gene sequencing that make testing economical and expeditious, more labs have the ability to not only detect hepatitis, but also to identify any genetic variants that may be associated with the increased number of pediatric hepatitis cases appearing around the world.

JP Schlingman

Related Information:

As Mysterious Child Hepatitis Cases Swell, Scientists Study Symptoms and Causes

With Usual Suspects Ruled Out, Disease Detectives Try to Crack Mystery of Viral Hepatitis Cases in Kids

CDC Alerts Providers to Hepatitis Cases of Unknown Origin

Hepatitis Outbreak in Children: What to Know

CDC Gives New Information about Mysterious Hepatitis Cases in Children

CDC Investigating 109 Unusual Hepatitis Cases in Kids in Outbreak

WHO: Multi-country—Acute, Severe Hepatitis of Unknown Origin in Children

Direct-to-Consumer Health Testing Company LetsGetChecked Acquires Veritas Genetics, Veritas Intercontinental, and BioIQ

As demand for DTC at-home genetic testing increases among consumers and healthcare professionals, clinical laboratories that offer similar assays may want to offer their own DTC testing program

Things are happening in the direct-to-consumer (DTC) medical laboratory testing market. Prior to the pandemic, the number of consumers interested in ordering their own diagnostic tests grew at a rapid rate. The SARS-CoV-2 outbreak, however, and the need for consumers to access COVID-19 tests, caused DTC test sales to skyrocket.

One company benefiting from the DTC trend is New York City-based LetsGetChecked. In March, it announced its acquisition of Veritas Genetics which included that company’s Veritas Intercontinental business division. No purchase price was disclosed.

LetsGetChecked describes itself as a “virtual care company that allows customers to manage their health from home, providing direct access to telehealth services, pharmacy, and [clinical] laboratory tests with at-home sample collection kits for a wide range of health conditions,” according to the company’s LinkedIn page.

The acquisition of Veritas brings whole genome sequencing capabilities to LetsGetChecked, according to MobiHealthNews.

“Through these acquisitions, LetsGetChecked will leverage the power of whole genome sequencing to launch a full lifecycle of personalized healthcare, delivering the most comprehensive health testing and care solution on the market,” said Peter Foley, Founder and CEO of LetsGetChecked in a press release.

“By integrating Veritas Genetics’ and Veritas Intercontinental’s capabilities with LetsGetChecked’s scalable diagnostic and virtual care infrastructure, we are able to turn comprehensive genetic insights into practical recommendations and lifestyle changes, guided by clinical experts,” he added.

George Church, PhD
“Our mission to deliver the benefits of whole genome sequencing to millions of individuals continues as part of the LetsGetChecked family. I am particularly excited about the opportunity to combine genetic testing with the broad spectrum of virtual and at-home care models offered by LetsGetChecked. I expect these acquisitions will change the future of personalized healthcare as we know it,” said geneticist George Church, PhD, co-founder of Veritas Genetics, and Professor of Health Sciences and Technology at Harvard and MIT, in a press release. (Photo copyright: Wyss Institute at Harvard University.)

Leveraging the Power of Whole Genome Sequencing

To date, LetsGetChecked claims it has delivered nearly three million at-home direct-to-consumer tests and served more than 300 corporate customers with testing services and biometric screening solutions since its founding in 2015.

The company focuses on manufacturing, logistics, and lab analysis in its CAP-accredited, CLIA-certified laboratory in Monrovia, Calif., as well as physician support, and prescription fulfillment. The DTC company’s products include at-home tests for women’s health, men’s health, basic wellness, sexual health, and SARS-CoV-2 testing.

Veritas Genetics also was a DTC testing company co-founded by internationally-known geneticist George Church, PhD. In 2016, the company announced it would deliver a whole human genome sequence (WGS) for just $999—breaking the $1,000 cost barrier for whole genome sequencing.

In “Veritas Genetics Drops Its Price for Clinical-Grade Whole-Genome Sequencing to $599, as Gene Sequencing Costs Continue to Fall,” Dark Daily covered how just three years later, in 2019, the company announced it would do a WGS for only $599.

“There is no more comprehensive genetic test than your whole genome,” Rodrigo Martinez, former Veritas Chief Marketing and Design Officer, told CNBC. “So, this is a clear signal that the whole genome is basically going to replace all other genetic tests. And this [price drop] gets it closer and closer and closer.”

That market strategy did not succeed. By the end of 2019, the company announced it would cease operations in the United States but continue operations in Europe and Latin America. It has sought a buyer for the company since that time. Now, almost three years later, LetsGetChecked will become the new owner of Veritas Genetics.

Veritas’ primary product, myGenome was launched in 2018 as a whole genome sequencing and interpretation service to help consumers improve their health and increase longevity. The myGenome test screens for and provides insight on many hereditary diseases such as cancer, cardiovascular disease, and neurological disorders. It also provides observations on more than 50 personal traits and ancestry information.

In addition to bringing whole genome sequencing abilities to its test offerings for consumers, LetsGetChecked hopes the acquisitions will create new testing capabilities such as pharmacogenomics, cancer and viral screenings, and maternal fetal screenings.

“By integrating Veritas Genetics’ and Veritas Intercontinental’s genetics offering with our scalable virtual care infrastructure, we are able to leverage the power of whole genome sequencing to launch a full lifecycle of personalized healthcare, which has always been our goal,” Foley told MobiHealthNews.

Veritas Genetics and Veritas Intercontinental will continue to operate under the LetsGetChecked family of companies.

BioIQ also Acquired by LetsGetChecked

In early May, LetsGetChecked also acquired diagnostic testing and health improvement technology company BioIQ, which will continue to operate as a wholly-owned subsidiary.

BioIQ offers at-home tests, health screenings, and vaccinations to consumers. The company’s products include:

  • Heart health panel,
  • Lipid panel,
  • Respiratory panel,
  • Prevention panel, and
  • Wellness panel.

Individual tests offered by BioIQ include:

  • A1C,
  • COVID-19,
  • Hepatitis C test and
  • Sexually transmitted diseases.

BioIQ also offer e-vouchers for health screenings and vaccinations at participating retail pharmacies, clinical laboratories, and physician’s offices.

“The future of healthcare is in providing high-quality at-home diagnostics and care that comprehensively serve an individual’s health needs throughout their whole life,” said Foley in a press release about the BioIQ acquisition. “With this acquisition, LetsGetChecked gains a trusted partner with an extensive knowledge base and a breadth of experience in serving health plans and employer markets to deliver healthcare solutions at scale.”

These acquisitions by LetsGetChecked demonstrate how genetic testing companies are pivoting to new strategies. Clinical laboratories that perform genetic testing will want to monitor how these partnerships unfold in the future as healthcare consumers and providers continue to embrace at-home genetic testing.

JP Schlingman

Related Information:

Genetic Sequencing Opens New Doors—and Concerns—for Home Health Testing

LetsGetChecked to Acquire Veritas Genetics and Veritas Intercontinental to Unlock the Future of Personalized At-Home Healthcare

LetsGetChecked Scoops Up Genomics Company Veritas Genetics

Veritas Genetics Drops Its Price for Clinical-Grade Whole-Genome Sequencing to $599, as Gene Sequencing Costs Continue to Fall

LetsGetChecked Completes Acquisition of BioIQ

Smart Pacifier That Monitors Electrolyte Levels in Saliva Could Prove to Be Beneficial for Vital Care of Infants in Newborn Intensive Care Units

Tiny sensors with Bluetooth technology that measure useful biomarkers may eliminate need for invasive blood draws used for clinical laboratory tests

What if a baby’s pacifier could be used to measure electrolyte levels in newborns? An international research team has developed just such a device, and it has the potential to reduce invasive blood collections required to provide specimens for clinical laboratory testing of critical biomarkers. At the same time, this device may allow continuous monitoring of electrolyte levels with wireless alerts to caregivers.

Developed at Washington State University (WSU) Vancouver with researchers from the United States and South Korea, the wireless bioelectronic pacifier monitors electrolyte levels in newborn intensive care unit (NICU) babies and sends the collected data to caregivers and hospital information systems in real time.

Reliable Information from Consistent Monitoring

Typical blood draws for NICU babies can cause information gaps as they are usually  only performed twice a day. This can be problematic in cases where more frequent monitoring of these biomarkers is required to monitor the infant’s condition.

“We know that premature babies have a better chance of survival if they get a high quality of care in the first month of birth,” said Jong-Hoon Kim, PhD, Associate Professor at the WSU School of Electrical Engineering and Computer Science, in a WSU news release. “Normally, in a hospital environment, they draw blood from the baby twice a day, so they just get two data points. This device is a non-invasive way to provide real-time monitoring of the electrolyte concentration of babies.”

Kim is a co-corresponding author of the WSU study published in the peer-reviewed journal Biosensors and Bioelectronics, titled, “Smart Bioelectronic Pacifier for Real-Time Continuous Monitoring of Salivary Electrolytes.”

The smart pacifier (above) developed by researchers at the Washington State University School of Electrical Engineering and Computer Science—in collaboration with scientists in two South Korean institutions—provides continuous monitoring of sodium and potassium ion levels. This can help detect and prevent potentially dangerous dehydration issues in NICU babies without invasive blood draws for traditional clinical laboratory testing. (Photo copyright: University of Washington.)

How the Smart Pacifier Works

The miniature system developed by the WSU researchers utilizes a typical, commercially available pacifier outfitted with ion-selective sensors, flexible circuits, and microfluidic channels that monitor salivary electrolytes. These flexible, microfluidic channels attract the saliva when the pacifier is in the infant’s mouth which enables continuous and efficient saliva collection without the need for any type of pumping system. The gathered data is relayed wirelessly to caregivers using Bluetooth technology.

When the researchers tested their smart pacifier on infants, they discovered that the results captured from the device were comparable to information obtained from normal blood draws and standard clinical laboratory tests. Kim noted in the press release that technology currently in use to test infant saliva for electrolytes tend to be bulky, rigid devices that require a separate sample collection.

“You often see NICU pictures where babies are hooked up to a bunch of wires to check their health conditions such as their heart rate, the respiratory rate, body temperature, and blood pressure,” said Kim in the press release. “We want to get rid of those wires.”

The researchers intend to make the components for the device more affordable and recyclable. They also plan to perform testing for their smart pacifier on larger test groups to prove efficacy and hope the gadget will help make NICU treatment less disruptive for infant patients.

Co-authors on the WSU study include researchers from the Georgia Institute of Technology, and Pukyong National University and Yonsei University College of Medicine in South Korea.

Before the ‘Smart’ Pacifier Were ‘Smart’ Diapers!

Going as far back as 2013, Dark Daily has covered research into the use of sensors placed in wearables and disposables to detect and monitor health issues.

In “New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor,” Dark Daily reported on how the advent of digital technology and smartphones was moving medical laboratory testing out of the central laboratory and into the bedside, homes, and into diapers!

And this past fall, in “Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults,” we reported on researchers who were combining diagnostics with existing products to help medical professionals and patients monitor bodily functions and chronic diseases.

“It should be noted that the ability to put reliable diagnostic sensors in disposables like diapers has been around for almost a decade and does not seem to have caught on with either caregivers or the public,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication, The Dark Report. “Because the researchers who developed the pacifier are attempting to solve a problem for NICU babies, this solution might find acceptance.”

This is another example of how researchers are thinking outside the box as to how to measure critical biomarkers without the need to send a specimen to the core clinical laboratory and wait hours—sometimes overnight—for results.

JP Schlingman

Related Information:

Smart Pacifier Developed to Monitor Infant Health in Hospitals

Smart Bioelectronic Pacifier for Real-time Continuous Monitoring of Salivary Electrolytes

Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults

New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor

Australian Researchers Develop a Superior Genetic Blood or Saliva Test for Detecting Glaucoma in High-risk Individuals

Should the test prove clinically viable, it could lead to new biomarkers for eye disease diagnostics and a new assay for clinical laboratories

Scientists at Flinders University in Australia have developed a genetic blood or saliva test that, they say, is 15 times more effective at identifying individuals at high risk of glaucoma than current medical laboratory tests.

If so, this discovery could lead to new biomarkers for diagnostic blood tests that help medical professionals identify and treat various diseases of the eye. Their test also can be performed on saliva samples. The researchers plan to launch a company later in 2022 to generate an accredited test that can be used in clinical trials.

“Early diagnosis of glaucoma can lead to vision-saving treatment, and genetic information can potentially give us an edge in making early diagnoses, and better treatment decisions,” said lead researcher Owen Siggs, PhD, Associate Professor, College of Medicine and Public Health at Flinders University, in a university press release.

Flinders University researchers have been collaborating with scientists at the QIMR Berghofer Medical Research Institute and other research institutes worldwide for some time to identify genetic risk factors for glaucoma, the press release noted.

The researchers published their findings in the peer-reviewed journal JAMA Ophthalmology, titled, “Association of Monogenic and Polygenic Risk with the Prevalence of Open-Angle Glaucoma.”

“In the cross-sectional study of monogenic and polygenic variants related to the disease, the new genetic test was evaluated in 2,507 glaucoma patients in Australia and 411,337 people with or without glaucoma in the UK. The test, conducted using a blood or saliva sample, could potentially detect individuals at increased risk before irreversible vision loss happens,” Medical Device Network reported.

Jamie Craig, PhD
“Genetic testing is not currently a routine part of glaucoma diagnosis and care, but this test has the potential to change that,” said Jamie Craig, PhD, (above), Distinguished Professor, College of Medicine and Health at Flinders University in Australia and senior author of the study, in a press release. “We’re now in a strong position to start testing this in clinical trials,” he added. This is yet another example of how new research is identifying a novel biomarker that could be incorporated into a clinical laboratory test. (Photo copyright: Flinders University.)

Who Is at Risk for Glaucoma?

Glaucoma is a group of eye diseases that are typically caused by a buildup of pressure within the eye. The eyeball contains and produces a fluid called aqueous humour which provides nutrition to the eye and keeps the eye in a proper pressurized state. Any excess of this fluid should be automatically released via a drainage canal called the trabecular meshwork.

But that’s not always the case. When the fluid cannot drain properly, intraocular pressure is created. Most forms of glaucoma are characterized by this pressure, which can damage the optic nerve and eventually cause vision loss and even blindness. Treatments for the disease include medications, laser treatments, and surgery.

Anyone can develop glaucoma, but according to the Mayo Clinic, individuals at higher risk of the disease include: 

  • Individuals over the age of 60.
  • Those with a family history of glaucoma.
  • People of African, Asian, or Hispanic descent.
  • Patients with certain medical conditions, such as diabetes, heart disease, high blood pressure, and sickle cell anemia.
  • Those with corneas that are thin in the center.
  • Individuals who have had a past eye injury or certain types of eye surgery.
  • People who have taken corticosteroid medications, especially eyedrops, for an extended period of time.

Glaucoma is the second leading cause of blindness worldwide, particularly among the elderly. When diagnosed early, the condition is manageable, but even with treatment, about 15% of glaucoma patients become blind in at least one eye within 20 years.

According to the federal Centers for Disease Control and Prevention (CDC), approximately three million Americans are living with glaucoma. The disease often has no early symptoms, which is why it is estimated that about 50% of individuals who have glaucoma do not realize they have the illness.

Thus, a clinically-viable genetic test that is 15 times more likely to identify people at risk for developing glaucoma in its early stages would be a boon for ophthalmology practices worldwide and could save thousands from going blind.

More research and clinical trials are needed before the Flinders University genetic test for glaucoma becomes available. But the discovery alone demonstrates the importance of continuing research into identifying novel biomarkers that could be incorporated into useful clinical laboratory diagnostic tests.

JP Schlingman

Related Information:

A Game-changer for Glaucoma Diagnosis: Scientists Develop a Blood Test That is 15 Times More Likely than Current Methods to Identify High-risk Individuals Before Irreversible Vision Loss Occurs

Association of Monogenic and Polygenic Risk with the Prevalence of Open-Angle Glaucoma

Flinders University Develops Genetic Test for Glaucoma

The Majority of Glaucoma Cases Remain Undiagnosed in the US

Glaucoma Test ‘Best Yet’

Aqueous Humor Flow and Function

Mayo Clinic: Glaucoma Causes and Symptoms

Glaucoma-Global Clinical Trials Review, H2, 2021

Don’t Let Glaucoma Steal Your Sight!

Nagoya University Researchers Develop Highly Accurate MicroRNA Urine Test That Identifies Brain Cancer in Patients with Tumors

MicroRNAs in urine could prove to be promising biomarkers in clinical laboratory tests designed to diagnose brain tumors regardless of the tumor’s size or malignancy, paving the way for early detection and treatment

Researchers at Nagoya University in Japan have developed a liquid biopsy test for brain cancer screening that, they claim, can identify brain tumors in patients with 100% sensitivity and 97% specificity, regardless of the tumor’s size or malignancy. Pathologists will be interested to learn that the research team developing this technology says it is simple and inexpensive enough to make it feasible for use in mass screening for brain tumors.

Neurologists, anatomic pathologists, and histopathologists know that brain tumors are one of the most challenging cancers to diagnose. This is partly due to the invasive nature of biopsying tissue in the brain. It’s also because—until recently—clinical laboratory tests based on liquid blood or urine biopsies were in the earliest stages of study and research and are still in development.

Thus, a non-invasive urine test with this level of accuracy that achieves clinical status would be a boon for the diagnosis of brain cancer.

Researchers at Japan’s Nagoya University believe they have developed just such a liquid biopsy test. In a recent study, they showed that microRNAs (tiny molecules of nucleic acid) in urine could be a promising biomarker for diagnosing brain tumors. Their novel microRNA-based liquid biopsy correctly identified 100% of patients with brain tumors.

The Nagoya University scientists published their findings in the journal ACS Applied Materials and Interfaces, titled, “Urinary MicroRNA-based Diagnostic Model for Central Nervous System Tumors Using Nanowire Scaffolds.”

Atsushi Natsume, MD, PhD
Atsushi Natsume, MD, PhD (above), Associate Professor at Nagoya University, led the research team that created the simple, liquid biomarker urine test for central nervous system tumors that achieved 100% sensitivity and 97% specificity, regardless of the tumor’s size or malignancy. Such a non-invasive clinical laboratory test used clinically would be a boon to brain cancer diagnosis worldwide. (Photo copyright: Nagoya University.)

Well-fitted for Mass Screenings of Brain Cancer Patients

According to the National Cancer Institute (NCI), brain and other central nervous system (CNS) cancers represent 1.3% of all new cancer cases and have a five-year survival rate of only 32.6%.

In their published study, the Nagoya University scientists wrote, “There are no accurate mass screening methods for early detection of central nervous system (CNS) tumors. Recently, liquid biopsy has received a lot of attention for less-invasive cancer screening. Unlike other cancers, CNS tumors require efforts to find biomarkers due to the blood–brain barrier, which restricts molecular exchange between the parenchyma and blood.

“Additionally, because a satisfactory way to collect urinary biomarkers is lacking, urine-based liquid biopsy has not been fully investigated despite the fact that it has some advantages compared to blood or cerebrospinal fluid-based biopsy.

“Here, we have developed a mass-producible and sterilizable nanowire-based device that can extract urinary microRNAs efficiently. … Our findings demonstrate that urinary microRNAs extracted with the nanowire device offer a well-fitted strategy for mass screening of CNS tumors.”

The Nagoya University researchers focused on microRNA in urine as a biomarker for brain tumors because “urine can be collected easily without putting a burden on the human body,” said Atsushi Natsume, MD, PhD, Associate Professor in the Department of Neurosurgery at Nagoya University and a corresponding author of the study, in a news release.

A total of 119 urine and tumor samples were collected from patients admitted to 14 hospitals in Japan with CNS cancers between March 2017 and July 2020. The researchers used 100 urine samples from people without cancer to serve as a control for their test.

To extract the microRNA from the urine and acquire gene expression profiles, the research team designed an assembly-type microfluidic nanowire device using nanowire scaffolds containing 100 million zinc oxide nanowires. According to the scientists, the device can be sterilized and mass-produced, making it suitable for medical use. The instrument can extract a significantly greater variety and quantity of microRNAs from only a milliliter of urine compared to traditional methods, such as ultracentrifugation, the news release explained.

Simple Liquid-biopsy Test Could Save Thousands of Lives Each Year

While further studies and clinical trials will be necessary to affirm the noninvasive test’s accuracy, the Nagoya University researchers believe that, with the inclusion of additional technologies, a urine-based microRNA test could become a reliable biomarker for detecting brain tumors.

“In the future, by a combination of artificial intelligence and telemedicine, people will be able to know the presence of cancer, whereas doctors will be able to know the status of cancer patients just with a small amount of their daily urine,” Natsume said in the news release.

Biomarkers found in urine or blood samples that provide clinical laboratories with a simple, non-invasive procedure for early diagnosis of brain tumors could greatly increase the five-year survival rate for thousands of patients diagnosed with brain cancer each year. Such diagnostic technologies are also appropriate for hospitals and physicians interested in advancing patient-centered care.

Andrea Downing Peck

Related Information:

Urine Test Detects Brain Tumors with 97% Accuracy

Urinary MicroRNA-based Diagnostic Model for Central Nervous System Tumors Using Nanowire Scaffolds

Simple Urine Test May Help Early Detection of Brain Tumors

;