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US and UK Researchers Simultaneously Develop New Tests to Detect Prostate Cancer

Though still in trials, early results show tests may be more accurate than traditional clinical laboratory tests for detecting prostate cancer

Within weeks of each other, different research teams in the US and UK published findings of their respective efforts to develop a better, more accurate clinical laboratory prostate cancer test. With cancer being a leading cause of death among men—second only to heart disease according to the Centers for Disease Control and Prevention (CDC)—new diagnostics to identify prostate cancer would be a boon to precision medicine treatments for the deadly disease and could save many lives.

Researchers at the University of East Anglia (UEA) in Norwich, England, were working to improve the accuracy of the widely-used and accepted prostate-specific antigen (PSA) test. By contrast, researchers at Cedars-Sinai Cancer in Los Angeles, pursued a new liquid biopsy approach to identifying prostate cancer that uses nanotechnology.

Thus, these are two different pathways toward the goal of achieving earlier, more accurate diagnosis of prostate cancer, the holy grail of prostate cancer diagnosis.

Dmitry Pshezhetskiy, PhD

“There is currently no single test for prostate cancer, but PSA blood tests are among the most used, alongside physical examinations, MRI scans, and biopsies,” said Dmitry Pshezhetskiy, PhD (above), Professorial Research Fellow at University of East Anglia and one of the authors of the UEA study. “However, PSA blood tests are not routinely used to screen for prostate cancer, as results can be unreliable. Only about a quarter of people who have a prostate biopsy due to an elevated PSA level are found to have prostate cancer. There has therefore been a drive to create a new blood test with greater accuracy.” With the completion of the US and UK studies, clinical laboratories may soon have a new diagnostic test for prostate cancer. (Photo copyright: University of East Anglia.)

East Anglia’s Research into a More Accurate Blood Test

Scientists at the University of East Anglia (UEA) worked with researchers from Imperial College in London, Imperial College NHS Trust, and Oxford BioDynamics to develop a new precision medicine blood test that can detect prostate cancer with greater accuracy than current methods.

The epigenetic blood test they developed, called Prostate Screening EpiSwitch (PSE), can identify cancer-specific chromosome conformations in blood samples. The test works in tandem with the standard prostate-specific antigen (PSA) blood test to diagnose prostate cancer, according to an Oxford BioDynamics press release.

The researchers evaluated their test in a pilot study involving 147 patients. They found their testing method had a 94% accuracy rate, which is higher than that of PSA testing alone. They discovered their test significantly improved the overall detection of prostate cancer in men who are at risk for the disease. 

“When tested in the context of screening a population at risk, the PSE test yields a rapid and minimally invasive prostate cancer diagnosis with impressive performance,” Dmitry Pshezhetskiy, PhD, Professorial Research Fellow at UEA and one of the authors of the study told Science Daily. “This suggests a real benefit for both diagnostic and screening purposes.”

The UK scientists hope their test can eventually be used in everyday clinical practice as there is a need for a highly accurate method for prostate cancer screening that does not subject patients to unnecessary, costly, invasive procedures. 

The UEA researchers published their findings in the peer-reviewed journal Cancers, titled, “Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection.”

Cedars-Sinai’s Research into Nanotechnology Cancer Testing

Researchers from Cedars-Sinai Cancer took a different approach to diagnosing prostate cancer by developing a nanotechnology-based liquid biopsy test that detects the disease even in microscopic amounts.  

Their test isolates and identifies extracellular vesicles (EVs) from blood samples. EVs are microscopic non-reproducing protein and genetic material shed by all cells. Cedars-Sinai’s EV Digital Scoring Assay accurately extracts EVs from blood and analyzes them faster than similar currently available tests.

“This research will revolutionize the liquid biopsy in prostate cancer,” said oncologist Edwin Posadas, MD, Medical Director of the Urologic Oncology Program and co-director of the Experimental Therapeutics Program in Cedars-Sinai Cancer in a press release. “The test is fast, minimally invasive and cost-effective, and opens up a new suite of tools that will help us optimize treatment and quality of life for prostate cancer patients.”

The researchers tested blood samples from 40 patients with prostate cancer. They found that their EV test could distinguish between cancer localized to the prostate and cancer that has spread to other parts of the body.

Microscopic cancer deposits, called micrometastases, are not always detectable, even with advanced imaging methods. When these deposits spread outside the prostate area, focused radiation cannot prevent further progression of the disease. Thus, the ability to identify cancer by locale within the body could lead to new precision medicine treatments for the illness.

“[The EV Digital Scoring Assay] would allow many patients to avoid the potential harms of radiation that isn’t targeting their disease, and instead receive systemic therapy that could slow disease progression,” Posadas explained.

The Cedars-Sinai researchers published their findings in Nano Today, titled, “Prostate Cancer Extracellular Vesicle Digital Scoring Assay: A Rapid Noninvasive Approach for Quantification of Disease-relevant mRNAs.”

Other Clinical Laboratory Tests for Prostate Cancer Under Development

According to the American Cancer Society, the number of prostate cancer cases is increasing. One out of eight men will be diagnosed with the illness during his lifetime. Thus, developers have been working on clinical laboratory tests to accurately detect the disease and save lives for some time.

In “University of East Anglia Researchers Develop Non-Invasive Prostate Cancer Urine Test,” Dark Daily reported on a urine test also developed by scientists at the University of East Anglia that clinical laboratories can use to not only accurately diagnose prostate cancer but also determine whether it is an aggressive form of the disease.

And in “UPMC Researchers Develop Artificial Intelligence Algorithm That Detects Prostate Cancer with ‘Near Perfect Accuracy’ in Effort to Improve How Pathologists Diagnose Cancer ,” we outlined how researchers at the University of Pittsburgh Medical Center (UPMC) working with Ibex Medical Analytics in Israel had developed an artificial intelligence (AI) algorithm for digital pathology that can accurately diagnose prostate cancer. In the initial study, the algorithm—dubbed the Galen Prostate AI platform—accurately detected prostate cancer with 98% sensitivity and 97% specificity.

More research and clinical trials are needed before the new US and UK prostate cancer testing methods will be ready to be used in clinical settings. But it’s clear that ongoing research may soon produce new clinical laboratory tests and diagnostics for prostate cancer that will steer treatment options and allow for better patient outcomes.  

—JP Schlingman

Related Information:

The New Prostate Cancer Blood Test with 94 Percent Accuracy

Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection

Invention: A Blood Test to Unlock Prostate Cancer Mysteries

Prostate Cancer Extracellular Vesicle Digital Scoring Assay: A Rapid Noninvasive Approach for Quantification of Disease-relevant mRNAs

Could a Urine Test Detect Pancreatic and Prostate Cancer? Study Shows 99% Success Rate

University of East Anglia Researchers Develop Non-Invasive Prostate Cancer Urine Test

UPMC Researchers Develop Artificial Intelligence Algorithm That Detects Prostate Cancer with ‘Near Perfect Accuracy’ in Effort to Improve How Pathologists Diagnose Cancer

International Team of Scientists Develop Smart Diaper That Alerts Parents When It Is Soiled and Needs to Be Changed

Not the first smart diaper to come along, but consumers seem unready for diapers that can flag urinary tract infections and other biomarkers usually tested by clinical laboratories

Will wonders never cease? For centuries, parents had only their own senses to determine when infants needed diaper changing. Today, however, caregivers can rely on “smart diapers” to send alerts when a diaper is soiled. Crying, smelly babies may no longer be the gold standard in diaper management. But are smart diapers practical?

Scientists at Penn State University in collaboration with scientists from the Hebei University of Technology and Tianjin Tianzhong Yimai Technology Development Company in China think so.

Funded by the National Institutes of Health (NIH) and the National Science Foundation (NSF), Penn State’s new smart diaper is based on a simple pencil-on-paper design that utilizes an electrode sensor array treated with a sodium chloride solution that detects dampness when urine is present.

The sensor array is “so cheap and simple” it “could clear the way for wearable, self-powered health monitors for use not only in ‘smart diapers’ but also to predict major health concerns like cardiac arrest and pneumonia,” a Penn State new release noted.

However, clinical laboratory managers following similar developments probably know that this is not the first scientific effort to develop a smart diaper that uses some type of sensor to detect a biomarker and issue an alert to the wearer or caregivers.

For example, nine years ago, 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 a digital smart diaper invented by New York startup Pixie Scientific that constantly monitors a baby’s health to detect urinary tract infections, kidney problems, or dehydration before the health issue escalates. That smart diaper also uses a smartphone app to send data to the baby’s doctor.

In this latest research effort, the scientists published their findings in the journal Nano Letters, titled, “Pencil-on-Paper Humidity Sensor Treated with NaCl Solution for Health Monitoring and Skin Characterization.”

Huanyu "Larry" Cheng, PhD

“Our team has been focused on developing devices that can capture vital information for human health,” said Huanyu “Larry” Cheng, PhD (above), the James L. Henderson, Jr. Memorial Associate Professor of Engineering Science and Mechanics at Penn State in a news release. “The goal is early prediction for disease conditions and health situations, to spot problems before it is too late.” This is yet another example of how researchers are working to take more testing out of clinical laboratories and offer unique assays that can be used as wearables—whether as a diaper, a skin patch, or a smart watch. (Photo copyright: Penn State University.)

This Smart Diaper Is as Simple to Use as Paper and Pencil

The Penn State sensor array takes advantage of how paper naturally reacts to wetness and utilizes the graphite in pencil marking to interact with the water molecules and sodium chloride.

Once the water molecules are absorbed by the paper, the sodium chloride solution becomes ionized and electrons start to stream towards the graphite. This movement sets off the sensor, which is extremely sensitive to humidity. According to the study, the sensor can provide accurate readings over a wide range of humidity levels, from 5.6% to 90%.

“We wanted to develop something low-cost that people would understand how to make and use, and you can’t get more accessible than pencil and paper,” said Li Yang, PhD, a professor in the School of Artificial Intelligence at China’s Hebei University of Technology and one of the authors of the study, in the Penn State news release.

“You don’t need to have some piece of multi-million-dollar equipment for fabrication. You just need to be able to draw within the lines of a pre-drawn electrode on a treated piece of paper. It can be done simply and quickly.”

The diaper is connected to a tiny lithium battery. When the sensor recognizes an increase in humidity the battery powers transmission of the change to a smartphone via Bluetooth technology. This notification informs caregivers that it is time to change the diaper.

“That application was actually born out of personal experience,” explained Huanyu “Larry” Cheng, PhD, James L. Henderson, Jr. Memorial Associate Professor of Engineering Science and Mechanics at Penn State, one of the authors of the study and father to two young children. “There’s no easy way to know how wet is wet, and that information could be really valuable for parents. The sensor can provide data in the short-term, to alert for diaper changes, but also in the long-term, to show patterns that can inform parents about the overall health of their child.”

Do Consumers Want Smart Diapers?

Research into such wearable sensors has been gaining momentum in the scientific community as a novel way to detect and deal with several medical conditions. The Penn State team hopes that devices such as their smart diaper can be used in the future to alert caregivers about the overall health of their children and clients.

“Our team has been focused on developing devices that can capture vital information for human health,” Cheng said. “The goal is early prediction for disease conditions and health situations, to spot problems before it is too late.” 

Previous research teams have had similar smart diaper goals.

In “Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults,” we covered how a team of researchers at Tokyo University of Science (TUS) in Japan had developed a diaper that detects blood glucose levels in individuals living with diabetes, a debilitating illness.

However, these types of products have yet to gain significant popularity with consumers. Regardless, sales projections for smart diapers remain positive.

According to a MarketsandMarkets report, the smart diaper market, estimated to be $646 million (US) in 2021, is expected to surpass $1.5 billion by 2026. The demand for smart diapers, the report notes, is increasing due to:

  • Growing elderly populations,
  • Rising disposable incomes,
  • Increasing personal hygiene awareness,
  • Growing populations in emerging countries, and
  • Expanding preference for advanced technology when it comes to health.

So, it’s uncertain if consumers are now ready for a device in their baby’s diaper telling them it’s time for a change. Regardless, researchers will likely continue developing tools that combine new diagnostics with existing products to help people better understand and monitor their health and the health of their loved ones.

Meanwhile, clinical laboratory managers and pathologists can remain on the alert for future published studies and press releases announcing new wearable items containing sensors, such as smart diapers. The unanswered question is whether both consumers and healthcare professionals will consider these novel inventions useful devices in the care of young and old alike.

—JP Schlingman

Related Information:

Researchers Developed a “Smart Diaper” That Sends Notifications to Parents’ Phones

New Sensor Enables ‘Smart Diapers,’ Range of Other Health Monitors

Pencil-on-Paper Humidity Sensor Treated with NaCl Solution for Health Monitoring and Skin Characterization

Diaper Which Signals Time for Change by Chinese Team

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

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

Smart Diapers Market by End-Use (Babies, Adults), Technology (RFID Tags, Bluetooth Sensors), and Geography (North America, Asia Pacific, Europe, and Rest of World) (2022—2026)

The Smart Diaper is Coming. Who Actually Wants It?

University of Washington Researchers Use Genomic Analysis to Track Shigella Infections as Decreased Cost of Gene Sequencing Aids Public Health Research

Another study in the United Kingdom that also used genomic analysis to understand drug-resistant Shigella produced findings that may be useful for microbiologists and medical laboratory scientists

From the onset of an infectious disease outbreak, public health officials, microbiologists, and clinical laboratory managers find it valuable to trace the origin of the spread back to the “index case” or “patient zero”—the first documented patient in the disease epidemic. Given the decreased cost of genomic analysis and improved accuracy of gene sequencing, infectious disease researchers are finding that task easier and faster than ever.

One recent example is a genomic study conducted at University of Washington (UW) in Seattle that enabled researchers to “retrace” the origin and spread of a “multidrug-resistant Shigellosis outbreak” from 2017 to 2022. “The aim of the study was to better understand the community transmission of Shigella and spread of antimicrobial resistance in our population, and to treat these multi-drug resistant infections more effectively,” the UW scientists stated in a new release.

Shigellosis (aka, bacillary dysentery) is a highly contagious disease of the intestines that can lead to hospitalization. Symptoms include fever, stomach cramps, diarrhea, dysentery, and dehydration.

“Additional analysis of the gut pathogen and its transmission patterns helped direct approaches to testing, treatment, and public health responses,” the UW news release states.

Usually prevalent in countries with public health and sanitation limitations, the “opportunistic” Shigella pathogen is now being seen in high-income countries as well, UW reported.

The researchers published their findings in Lancet Infectious Diseases, titled, “Genomic Reconstruction and Directed Interventions in a Multidrug-Resistant Shigellosis Outbreak in Seattle, WA, USA: A Genomic Surveillance Study.”

Ferric Fang, MD

“You can’t really expect an infectious disease to remain confined to a specific at-risk population. [Shigella infections are] very much an emerging threat and something where our public health tools and therapeutic tools have significant limitations,” infectious disease specialist Ferric Fang, MD (above) told CIDRAP News. Fang is a UW professor of Microbiology and Clinical Laboratory Medicine and a corresponding author of the UW study. (Photo copyright: University of Washington.)

Why are Shigella Cases Increasing?

The US Centers for Disease Control and Prevention (CDC) records more than 450,000 shigellosis infections each year in the US. The most common species in the US, according to CDC statistics, is Shigellaa sonnei.

Other members of the genus include:

Generally, Shigella infects children, travelers, and men who have sex with men (MSM), the CDC noted.

The UW researchers were motivated to study Shigella when they noticed an uptick in drug-resistant shigellosis cases in Seattle’s homeless population in 2020 at the beginning of the COVID-19 pandemic, Center for Infectious Disease Research and Policy News (CIDRAP News) reported.

“Especially during the pandemic, a lot of public facilities were closed that homeless people were used to using,” infectious disease specialist Ferric Fang, MD, told CIDRAP News. Fang is Professor of Microbiology and Laboratory Medicine at University of Washington and corresponding author of the UW study.

The researchers studied 171 cases of Shigella identified from 2017 to 2022 by clinical laboratories at Harborview Medical Center and UW Medical Center in Seattle. According to CIDRAP News, the UW researchers found that:

  • 46% were men who have sex with men (MSM).
  • 51% were people experiencing homelessness (PEH).
  • Fifty-six patients were admitted to the hospital, with eight to an intensive care unit.
  • 51% of isolates were multi-drug resistant (MDR).

Whole-Genome Sequencing Reveals Origin

The UW scientists characterized the stool samples of Shigella isolates by species identification, phenotypic susceptibility testing, and whole-genome sequencing, according to their Lancet Infectious Diseases paper. The paper also noted that 143 patients received antimicrobial therapy, and 70% of them benefited from the treatment for the Shigella infection.

Whole-genome sequencing revealed that two strains of Shigella (S. flexneri and S. sonnei) appeared first in Seattle’s MSM population before infecting the PEM population.

The genomic analysis found the outbreak of drug-resistant Shigella had international links as well, according to CIDRAP News:

  • One S. flexneri isolate was associated with a multi-drug resistant (MDR) strain from China, and
  • S. sonnei isolates resembled a strain characteristic of a current outbreak of MDR Shigella in England.

“The most prevalent lineage in Seattle was probably introduced to Washington State via international travel, with subsequent domestic transmission between at-risk groups,” the researchers wrote.

“Genomic analysis elucidated not only outbreak origin, but directed optimal approaches to testing, treatment, and public health response. Rapid diagnostics combined with detailed knowledge of local epidemiology can enable high rates of appropriate empirical therapy even in multidrug-resistant infection,” they continued.

UK Shigella Study Also Uses Genomics

Another study based in the United Kingdom (UK) used genomic analysis to investigate a Shigella outbreak as well.

Motivated by a UK Health Security Agency report of an increase in drug-resistance to common strains since 2021, the UK researchers studied Shigella cases from September 2015 to June 2022.

According to a paper they published in Lancet Infectious Diseases, the UK researchers “reported an increase in cases of sexually transmitted S. flexneri harboring blaCTX-M-27 (an antibiotic-resistant gene) in England, which is known to confer resistance to third-generation cephalosporins (antibiotics),” the researchers wrote.

Their analysis of plasmids (DNA with genes having antibiotic resistance) revealed a link in two drug-resistant Shigella strains at the same time, CIDRAP News explained.

“Our study reveals a worsening outlook regarding antimicrobial-resistant Shigella strains among MSM and highlights the value of continued integration of genomic analysis into surveillance and research,” the UK-based scientists wrote.

Current challenges associated with Shigella, especially as it evades treatment, may continue to demand attention from microbiologists, clinical laboratory scientists, and infectious disease specialists. Fortunately, use of genomic analysis—due to its ongoing improvements that have lowered cost and improved accuracy—has made it possible for public health researchers to better track the origins of disease outbreak and spread.    

Donna Marie Pocius

Related Information:

Genomic Reconstruction and Directed Interventions in a Multidrug-Resistant Shigellosis Outbreak in Seattle, Washington, USA: a Genomic Surveillance Study.

Genomics Aids Study of Seattle 2017-22 Shigella Outbreak

Q/A: Shigella—Shigellosis

A Spotlight on Growing Threat of Drug-Resistant Shigella

Emergence of Extensively Drug-Resistant and Multidrug-Resistant Shigella flexneri serotype 2a Associated with Sexual Transmission Among Gay, Bisexual, and Other Men Who Have Sex with Men, in England: A Descriptive Epidemiological Study

With New Daily Monkeypox Cases Now in Single Digits, Can We Declare the Mission Accomplished?

Coordinating at-home testing for monkeypox may provide opportunities for clinical laboratories to add value for their physician clients

Microbiologists and clinical laboratory managers who oversee medical laboratory tests for monkeypox (aka, mpox) will be interested to learn that, according to the US Centers of Disease Control (CDC), cases per day have dropped into the single digits.

The United States led the world in cases during the 2022-2023 outbreak, according to the most recent CDC statistics. As of February 15, the US has reported 30,193 cases of monkeypox with 32 deaths.

Nevertheless, January 31 was the day that the US public health emergency involving monkeypox officially expired. Data from the World Health Organization shows the number of daily monkeypox cases in most countries around the world is declining, although numbers of cases are still increasing in some South American countries.

The global monkeypox outbreak appears to have slowed considerably, but are we out of the woods?

Jonathan Mermin, MD

“There were concerns that there would be ongoing transmission and that ongoing transmission would become endemic in the United States like other STIs: gonorrhea, chlamydia, syphilis. We have not seen that occur,” Jonathan Mermin, MD (above), Director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention at the CDC, told CNN.” We are now seeing three to four cases a day in the United States, and it continues to decline. And we see the possibility of getting to zero as real.” This decline in monkeypox test corresponds with a similar decline in COVID-19 clinical laboratory testing as well. (Photo Copyright: CDC.)

Untried Vaccine and At-home Testing for Monkeypox

When the monkeypox outbreak began in May of 2022, there were concerns about the US’ level of preparedness for dealing with a second pandemic while also battling COVID-19. But monkeypox was not entirely unknown to the scientific and medical communities.

Monkeypox first appeared in 1958 amongst a colony of monkeys being kept for research. The origin of the disease is not known. According to the CDC, the first reported human case of monkeypox was in 1970. Prior to the 2022 outbreak, most cases were found in central and western African countries. Cases outside of those areas could be traced back to travel from those specific countries.

When cases of monkeypox first appeared in the US, public health officials were concerned about the availability of testing, vaccines, and treatments. As CNN reported, though there was a new vaccine available, its effectiveness against monkeypox had never been tested on humans.

That treatment, known as TPOXX (Tecovirimat), was an antiviral drug approved by the FDA in 2018 to treat smallpox in adults and children, according to an FDA factsheet. The drug was difficult to obtain, and it took until August of 2022 for the federal government to declare monkeypox a public health emergency. That allowed it to deploy emergency funds towards fighting the outbreak.

The US government eventually set up a task force to address the outbreak led by Robert Fenton Jr. from the Federal Emergency Management Agency (FEMA), and Demetre Daskalakis, MD, Director of the CDC’s Division of HIV/AIDS Prevention (DHAP) in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).

The demographic found to be at the highest risk of monkeypox infection were men who have sex with other men. According to MedPage Today, “Daskalakis had both pandemic experience as former senior lead on equity in COVID-19 data and engagement for the New York City Department of Health and Mental Hygiene and an ‘in’ with the LGBTQ+ community from his work in HIV prevention and his transparency about being a gay man.”

When comparing monkeypox to HIV, Daskalakis said, “This one [monkeypox], you don’t have to change behaviors for generations; it’s for a few months. Once you build your force field of immunity with vaccines, people can make their own informed decisions about their risk.”

Opportunities for Clinical Laboratories

So, how should clinical laboratories respond if there’s another monkeypox flare up?

Daskalakis advocates for home testing. “People that are going to order home tests are going to be motivated to action in other ways. And so, thinking about HIV home testing, which was the grandparent of COVID-19 home testing, this really shows us how you reach people you’re not going to reach when you have lab-based, provider-only testing … When you look at the HIV home testing data from the CDC, 26% of the people that ordered a home test had never been tested before. That is way higher than what you would expect,” he told MedPage Today.

In “Healthcare Experts Say Consumers Are Ready for Self-Test Flu Kits, but Are Physicians and Clinical Laboratories Ready to Let That Cat Out of the Bag?Dark Daily explored similar opportunities for clinical laboratories to be instrumental in increasing consumers safety by helping patients accurately collect samples, administer tests, and understand test results.

We are not out of the woods in regard to monkeypox, vigilance is still required. But with existing harm reduction measures in the most vulnerable community, at-home testing and advancements in vaccines could help us keep our numbers as low as possible.

Ashley Croce

Related Information:

2022 (Mpox) Outbreak Cases and Data

About Mpox

Mpox Is Almost Gone in the US, Leaving Lessons and Mysteries In Its Wake

Mpox Is No Longer a Public Health Emergency in the US

2022-23 Mpox (Monkeypox) Outbreak: Global Trends

Where Did All the Monkeypox Go?

Healthcare Experts Say Consumers Are Ready for Self-Test Flu Kits, but Are Physicians and Clinical Laboratories Ready to Let That Cat Out of the Bag?

Australia’s NSW Health Chooses Epic for its Statewide Patient EHR

Five clinical laboratory information systems are part of the transition that will create a single statewide EMR for all New South Wales patients

In a massive project, Australia’s New South Wales Ministry of Health (NSW Health) has selected health information system developer Epic to unify its five pathology laboratory information management systems (LIMS), nine electronic medical record systems (EMR), and six patient administration systems (PAS) into a statewide single digital patient record (SDPR).

According to ITnews, providers in New South Wales currently use LIMS systems by Citadel Health and Integrated Software Solutions OMNI-Lab, EMR systems by Oracle Cerner and Orion Health, and patient administration systems from Oracle Cerner and DXC.

“The SDPR will consolidate geographically fragmented EMR, PAS, and LIMS systems to create a detailed lifelong patient record and deliver cost savings,” NSW Health said in a news release.

NSW Health is the largest public health system in Australia with more than 220 public hospitals, 16 Local Health Districts, and three Specialty Networks. NSW Health Pathology operates more than 60 pathology laboratories (clinical laboratories in the US) and has 150 patient service centers.

Andrew Montague

“While this initiative will provide untold benefits to all the patients of NSW, we are excited about its potential for improving the health outcomes of our regional patients,” said Andrew Montague (above), former Chief Executive, Central Coast Local Health District in a press release. “By enabling greater collaboration across all local health districts and specialty health networks, the Single Digital Patient Record will provide clinicians with even better tools to keep the patient at the center of everything we do.” This project is more market evidence of the trend to bring clinical laboratory test results from multiple lab sites into a single data repository. (Photo copyright: Coast Community News.)

Cloud-based Realtime Access to Patient Records

Australia has a population of about 26 million and New South Wales, a state on the east coast, is home to more than eight million people. Though the scale of healthcare in Australia is much smaller than in the US, this is still a major project to pull patient data together from all the NSW hospitals, physicians’ offices, and other healthcare providers such as clinical laboratories and pathology practices.

With the change, NSW clinicians will benefit from a cloud–based system offering up real-time access to patients’ medical records, NSW Health Pathology Chief Executive Tracey McCosker told ITnews.

“Patients and our busy staff will benefit from clinical insights gained from the capture of important new data. Our work in pathology is vital to the diagnostic process and developing a statewide laboratory information management system will ensure we provide the best possible services,” McCosker told ITnews.

The KLAS Research report, “US Hospital Market Share 2022,” states that Epic, located in Verona, Wisconsin, has the largest US electronic health record (EHR) market share, Healthgrades noted. According to KLAS:

NSW Health’s decision to engage Epic came after a process involving 350 clinicians, scientists, and technical experts, Zoran Bolevich, MD, Chief Executive of eHealth NSW and NSW Health’s Chief Information Officer, told ITnews.  

NSW Health’s Goal for Statewide Digital Patient Record

It was in December 2020 when NSW Health announced its plan to create the SDPR. 

“Our vision is to be able to provide a single, holistic, statewide view of every patient—and for that information to be readily accessible to anyone involved in the patient’s care,” Bolevich said in the news release.

The SDPR, according to NSW Health, will address the following:    

Challenges:

  • Current systems not connected statewide.
  • Inaccessible patient data.
  • Duplicative data collection.
  • Gaps in decision-making.

Goals:

  • Improve health outcomes.
  • Create patient centricity.
  • Leverage insights.

NSW’s government has already invested more than $106 million in the SDPR, Healthcare IT News reported.

Other Large EHR Rollouts

NSW Health is not the only large organization to take on such an ambitious project of creating a large-scale digital patient record. And not always to a successful conclusion.

The US Department of Veterans Affairs (VA)—also intent on EHR modernization—recently announced it is suspending roll-out of the Oracle Cerner EHR at VA centers until June 2023 to address technical issues affecting appointments, referrals, and test results.

Four VA centers in Washington, Oregon, and Ohio already went live with the system in 2022.

“We are delaying all future deployments of the new EHR while we fully assess performance and address every concern. Veterans and clinicians deserve a seamless, modernized health record system, and we will not rest until they get it,” said Deputy Secretary of Veterans Affairs Donald Remy, JD, in a news release.

For its part, Oracle Cerner wrote federal lawmakers noting the importance of continuing the project, which will move the VA away from its former VistA health information system. 

“Modernization requires change and some short-term pain for the long-term benefits of a modern technology infrastructure,” noted Oracle Cerner Executive Vice President Ken Glueck in the letter, Becker’s Health IT reported. “A modernization project of this scale and scope necessarily involves time to untangle the decades of customized processes established in support of VistA, which inevitably involves challenges.”

NSW Health’s goal is to build a single repository of health information—including lab test results from multiple clinical laboratory sites. When finished NSW Health expects that sharing patient data will contribute to producing better healthcare outcomes.

However, the VA’s experience—and several other similar attempts at large-scale electronic patient record installations—suggest the work ahead will not be easy. But for NSW Health, it may be worth the effort.   

—Donna Marie Pocius

Related Information:

NSW Health Taps Epic for Statewide, Single Digital Patient Record

Single Digital Patient Record Set to Deliver Vastly Improved Patient Experience

NSW Health to Partner with Epic in the Next Step Towards its Digital Healthcare System

US Hospital Market Share 2022: Strong Purchasing Energy across Large, Small, and Standalone Hospitals

EHR Market Share 2021: 10 Things to Know About Major Players Epic, Cerner, Meditech and Allscripts

Single Digital Patient Record (SDPR)

New South Wales Invests $106 Million in Single EMR System

Recent Separate Business Transactions by Fujifilm and GE Healthcare Suggest Bullish Outlook for Faster Adoption of Digital Pathology

Fujifilm acquired Inspirata’s Dynamyx digital pathology technology and business while GE Healthcare announced a partnership with Tribun Health in Europe

Clinical pathology laboratories, especially in the US, have been slow to adopt digital imaging systems. But recent industry deals suggest that the market may soon heat up, at least in the eyes of vendors. These collaborators may hope that, by integrating diagnostic data, the accuracy and productivity of anatomic pathologists will improve while also shortening the time to diagnosis.

In a December press release, Tokyo-based Fujifilm announced it acquired the global digital pathology business of Inspirata, including its Dynamyx digital pathology system. Inspirata is a Tampa-based cancer informatics company.

In the press release, Fujifilm stated that 85% of US healthcare organizations use analog systems for pathology. That compares with 86% in Europe and 90% in Asia, the company stated.

“Acquiring Inspirata’s digital pathology business allows Fujifilm to be an even stronger healthcare partner—bridging a technological gap between pathology, radiology, and oncology to facilitate a more collaborative approach to care delivery across the enterprise,” said Fujifilm CEO and president Teiichi Goto in the press release.

The press release cited data from Signify Research, a healthcare technology marketing data firm that is predicting the global market for digital pathology systems would double from $320 million in 2021 to $640 million by 2025.

Fujifilm previously had a deal with Inspirata to sell the Dynamyx system exclusively in the UK, Italy, Spain, Portugal, Belgium, the Netherlands, and Luxembourg, an August press release noted.

Henry Izawa

“A $320 million global industry in 2021 projected to reach $640 million by 2025, the rising number of cancer cases and the demonstrated benefits of digital pathology are fueling significant demand and market growth in the hospital and pharmaceutical industries,” said Henry Izawa (above), president and CEO, Fujifilm Healthcare Americas Corporation, in a press release. “These evolving clinical needs fuel Fujifilm’s investment and innovation in the digital revolution, and we look forward to introducing Dynamyx and its host of unique features and benefits to our Synapse customers and prospects as we strive to enable more efficient medical diagnosis and high-quality care.” (Photo copyright: LinkedIn.)

GE Healthcare Partners with Tribun Health

The Fujifilm acquisition followed an October 18 announcement of a collaboration between GE Healthcare and digital pathology company Tribun Health in Europe to provide an interface between the latter’s digital pathology software and GE Healthcare’s Edison Datalogue image-management system.

In announcing their new collaboration, GE Healthcare and Tribun Health said the integration of their systems—Edison Datalogue and the Tribun Health suite—would foster collaboration between pathologists and clinicians by providing a consolidated location for imaging records. This capability is especially important in oncology, they said.

“The oncology care pathway is one of the most complex with multiple steps involving a variety of specialists, complex tools, frequent decisions, and large data sets,” said GE Healthcare CEO of Enterprise Digital Solutions Nalinikanth Gollagunta in a GE press release. “With this digital pathology collaboration, we continue our journey towards simplifying the oncology care pathway with improved data management, the digitization of pathology, and streamlined data access.”

Tribun Health, based in Paris, France, offers a digital pathology platform that incorporates a camera system, artificial intelligence (AI)-based analysis, remote collaboration, and storage management, plus integration with third-party automation apps.

GE Healthcare claims that Edison Datalogue has the largest share of the Vendor Neutral Archive (VNA) market. That term refers to image archiving systems that use standard formats and interfaces instead of proprietary formats. They are an alternative to the more widely used Picture Archiving and Communications Systems (PACS) used in medical imaging.

The collaboration between the companies “is probably a strategic move to position GE as an integrator of imaging data and digital pathology data in oncology,” said Robert Michel Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

GE’s History with Dynamyx

This is not GE Healthcare’s first foray into digital pathology. In fact, the company had a major hand in launching the very Dynamyx system that Fujifilm recently acquired.

Dynamyx was originally developed by digital pathology technology company Omnyx, LLC, which was a joint venture formed in 2008 between GE Healthcare and the University of Pittsburgh Medical Center (UPMC).

In “GE Healthcare Sells Omnyx to Inspirata,” The Dark Report interviewed Inspirata CEO Satish Sanan who at that time said the acquisition would allow his company to offer “a fully integrated, end-to-end digital pathology solution” in Canada and Europe. But GE Healthcare chose to end the partnership in 2016, citing regulatory uncertainty and variable global demand. Two years later, GE sold Omnyx to Inspirata.

GE Healthcare’s new collaboration with Tribun Health shows that the company “still recognizes the value of the pathology data in cancer diagnosis and wants to be in a position to manage that digital pathology data,” Michel said.

Fujifilm’s Plans

Fujifilm said it will incorporate Dynamyx into its Synapse Enterprise Imaging suite, which includes VNA, Radiology PACS, and Cardiology PACS. “Future releases of Dynamyx will also create opportunities for Fujifilm to support pharmaceutical and contract research organizations with toxicity testing data management for drug development,” the company stated in the press release.

US-based subsidiary Fujifilm Healthcare Americas Corporation will handle future development of the Dynamyx system. In the US, the system is currently cleared for the US Food and Drug Administration (FDA) for use with Leica’s Aperio AT2 DX scanner and Philips’ Ultra Fast Scanner.

With its recent moves into digital pathology, Fujifilm will be taking on major competitors including Philips, Danaher, and Roche, MedTech Dive reported.

Stephen Beale

Related Information:

Fujifilm Announces Asset Purchase Agreement with Inspirata, Inc. to Acquire the Company’s Digital Pathology Business

Fujifilm Agrees to Buy Inspirata’s Dynamyx in Challenge to Philips for Digital Pathology Market

GE Healthcare Announces Collaboration to Advance Digital Transformation of Pathology

Leica, Philips Come Out on Top in Digital Pathology Systems Market, KLAS Finds

GE Healthcare Sells Omnyx to Inspirata

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