Danaher’s chief medical officer, Maximilian Schmid, says ‘infrastructure is there’ to push forward whole slide imaging.
Based on discussions at the recent Association for Diagnostics & Laboratory Medicine’s (ADLM) 2025 conference and observations from other sources, digital pathology trends continue to show sluggish adoption by clinical laboratories and anatomic pathology practices in the US. However, proponents of whole slide imaging say now is a prime opportunity to integrate the technology with a patient-centric care approach.
At least 65 vendors at the ADLM 2025 exhibitor hall indicated that their products touched whole slide imaging or digital pathology, showing this area is a hot focus for sellers.
Based on its customers, Leica has one of the largest installation bases of digital pathology scanners in the world. From that perspective, the technology is available, yet obstacles remain.
“The infrastructure is there,” said Maximilian Schmid, MD, chief medical officer at Danaher Diagnostics. “How do we bring it to the patients?”
Danaher Corporation, which held a press briefing at ADLM 2025, is parent company to Leica.
ADLM 2025 took place in Chicago July 27-31at McCormick Place. (Photo credit: Scott Wallask.)
Labcorp Report Notes Costs as a Barrier
Anyone who has followed the slow progression of digital pathology knows adoption from the diagnostic lab industry has been lukewarm. In 2024, Labcorp released a report about clinical laboratory trends that indicated cost remained a hurdle to further use of digital pathology scanners and software. Based on a survey of 115 US-based pathologists, lab managers, and lab directors, the report concluded that just 33% of respondents had started orplanned to implementdigital pathologyin lab workflows.
“Industry adoption of digital pathology has been slower than expected, largely due to high initial costs,” Deborah Sesok-Pizzini, MD, MBA, chief medical officer at Labcorp, told Today’s Clinical Lab at the time. That publication is a partner brand to Dark Daily.
Digital Pathology Trends are Rosier in Europe
Leica has been able to convey a message to its customers that despite the initial costs, the return on investment for digital pathology is high in terms of more accurate diagnoses and quicker processes, Schmid said.
“When I look ahead 10 years, digital pathology will be as normal to labs as H&E staining,” he predicted, referring to common hematoxylin and eosin stains.
He added that while Labcorp’s study reflected US trends, digital pathology adoption is stronger elsewhere, based on what Danaher and Leica see with customers.
“Europe seems to be a little bit ahead in terms digitization,” including with whole-slide imaging, he noted. However, even in the US, “academic medical centers are moving very fast in this direction.”
Schmid’s assertion about Europe is supported by other sources. For example, a business case published in July 2024 by the UK’s National Health Service (NHS) for Wales indicated that Northern Ireland and Scotland had near-fully digitized cellular pathology programs for the NHS, and England was building up its network. Wales was seen as trailing behind these countries.
“The national move towards scanning of histological material for primary diagnosis and more recently, the adoption of artificial intelligence (AI)/computational pathology to improve the accuracy, reliability and quality of reports, means that most pathologists, especially new trainees who are already using digital technology, will, in the future, choose to work in departments where digital technology will enhance and underpin their diagnosis thus benefiting the quality of patient care,” the NHS Wales business case paper stated.
Computational Pathology’s Growing Role
Computational pathology—in other words, the use of data science, information, and digital technologies for laboratory medicine—is a key to moving precision medicine forward via digital pathology, said Nicole Selenko-Gebauer, MD, MBA, group vice president and chief innovation officer at Danaher Diagnostics.
“We need to complement technology-driven focuses” with a patient-centric approach, Selenko-Gebauer added.
Even in 2022, The Dark Report had alerted its readers to the promise of computational pathology, noting Mayo Clinic Laboratories’ early success in launching related clinical assessment goals based on digital pathology and artificial intelligence. (If you’re not a Dark Report subscriber, check out our 14-day free trial.)
Taken at that viewpoint, digital pathology trends related to patient care will be an important milestone for the technology.
“A pivotal moment will be the clinical utilization of digital pathology—that it works and is accurate,” Schmid said.
Lab leaders can now align with WHO’s new product profile to develop innovative diagnostics that address gaps in newborn infection detection and antimicrobial resistance prevention.
The World Health Organization (WHO) has unveiled a new target product profile aimed at guiding the development of in vitro diagnostic tests for detecting serious bacterial infections in newborns and young infants, including neonatal sepsis—a major cause of infant mortality worldwide. This initiative comes in response to alarming statistics: 2.3 million newborns die every year, with around 15% of these deaths linked to sepsis. The burden is heaviest in low- and middle-income countries, where access to timely diagnosis and treatment remains limited.
Current diagnostic methods such as blood cultures and molecular diagnostics are often inaccessible, expensive, or unreliable, particularly in resource-limited settings. They suffer from low sensitivity, long turnaround times, and high infrastructure demands, making them poorly suited for the urgent needs of frontline healthcare facilities.
Lab Leaders See Shift in Global Standards
For laboratory leaders, WHO’s newly released target product profile for diagnosing serious bacterial infections in newborns and young infants could represent a pivotal shift in global diagnostic standards. As the demand for timely, accurate, and affordable diagnostic tools grows—particularly in low-resource settings—lab leaders have a unique opportunity to play a central role in shaping the next generation of in vitro diagnostics.
The new profile to is designed to define the essential and desirable characteristics of diagnostic tools needed to improve early detection of infections in infants aged 0–59 days. The profile covers two major clinical scenarios: use in primary health care settings and in higher-level hospitals. It’s intended to assist developers, regulators, and public health officials in designing effective tools tailored to diverse healthcare environments.
Yvan Hutin, MD, PhD, Director of the Department of Antimicrobial Resistance at WHO, emphasized the urgency of the effort, stating, “Timely and accurate diagnosis tests for serious bacterial infection is critical to reducing newborn mortality.”
Hutin’s areas of expertise include epidemiology, prevention, care and treatment of viral hepatitis, public health training, economic analyses, and financing. He has co-authored more than 120 articles in peer-reviewed journals. (Photo credit: WHO)
Silvia Bertagnolio, MD, Head of the Antimicrobial Resistance Surveillance, Evidence and Laboratory Strengthening Unit at WHO noted, “This new target product profile outlines the essential features needed in diagnostic tools to improve clinical decision-making, reduce unnecessary antibiotic use and prevent antimicrobial resistance, especially in low-resource settings where the burden of neonatal sepsis remains critical.”
Targeted Care
In many communities, healthcare workers must make critical decisions about antibiotic treatment or hospital referrals based on clinical judgment alone, without reliable diagnostics. The new tools envisioned by WHO would help identify which infants truly need antibiotics or hospitalization, allowing for more targeted and effective care.
For laboratory leaders, the release of this target product profile is more than just a technical guideline, it’s a call to action. By aligning their diagnostic development and evaluation efforts with WHO’s outlined priorities, lab leaders can help fill a critical gap in newborn and infant care, particularly in underserved regions. Their expertise will be essential in translating this profile into practical, scalable solutions that improve early detection, guide appropriate treatment, and ultimately save lives. As stewards of innovation and quality in diagnostics, lab leaders are uniquely positioned to drive meaningful progress in the global fight against neonatal infections and antimicrobial resistance.
The NHS plans to map the DNA of all newborns in England over the next 10 years to evaluate their risk for hundreds of diseases
Clinical laboratories in the UK will soon see a new increase for specialized testing. Under a new 10-year plan by England’s National Health Service (NHS), every newborn baby in the country will have their complete DNA mapped using tiny blood samples taken from their umbilical cords shortly after birth. The blood samples will assess an infant’s risk for hundreds of diseases with the intent of predicting and preventing those illnesses while mitigating demand for services and saving money. The plan itself is set to be revealed in the near future.
In October, the NHS announced it would be analyzing the genetic code of up to 100,000 newborns via a small drop of blood collected from the heel. Currently, testing usually occurs when a baby is five days old and looks for nine rare, but serious gene disorders that develop in early childhood and have effective treatments available.
The new umbilical cord testing utilizes genomics, artificial intelligence (AI), predictive analytics, and other technologies to provide faster diagnoses and treatments for approximately 7,000 single-gene disorders.
“With the power of this new technology, patients will be able to receive personalized healthcare to prevent ill-health before symptoms begin, reducing the pressure on NHS services and helping people live longer, healthier lives,” stated Wes Streeting, NHS Secretary of State for Health and Social Care in a statement.
Wes Streeting, NHS Secretary of State for Health and Social Care said, “”Genomics presents us with the opportunity to leapfrog disease, so we’re in front of it rather than reacting to it.” (Photo credit: GOV.UK)
This new, whole genome sequencing procedure for infants is part of a 10-year plan by the NHS to establish major shifts in how healthcare is delivered in the UK to improve the quality of care and increase transparency. The intent is to move delivery from hospital to community, which includes the implementation of “neighborhood health teams” to aggregate services. The plan also includes transitioning from analog to digital methods and from treating illnesses to preventing them.
“Our 10-year plan will build on the founding promise of the NHS, so that it provides health care free at the point of risk, not just need,” said Streeting.
He also stated technological advances will help alleviate pressures on the NHS and contribute to its future success, thus improving the overall health of the population.
“As we deliver the transformational shifts in our 10-year plan, from hospital to community, analog to digital, and sickness to prevention, it will have radical implications for services,” he said. “Much of what’s done in a hospital today will be done on the high street, over the phone, or through the app in a decade’s time.”
While many scientists, doctors and patient advocacy groups applaud this testing on infants, there are some concerns it may spark an ethical debate. Parents will have the ability to give consent, but the testing may result in information they may not want to know, which could have a negative psychological effect on children and parents who are aware they have a higher risk for certain diseases.
There are also concerns regarding the security of crucial patient data and how such information can be prone to security breaches. The DNA and health records of infants are stored on secure systems and require strict authorization to access, but this type of data is very valuable to cyber hackers. The NHS has stressed it is prioritizing digital security measures, including vigorous cybersecurity, data governance and the implementation of ethical guidelines for AI development.
Robin Lovell-Badge, PhD, principal group leader and head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute also noted some reservations he has regarding how the collected data is provided to patients.
“You need people to have conversations with individuals who might be affected by genetic disease,” he said. “One of the things that worries me was an insufficient number of genetic counselors. It’s not just having the information, it’s conveying the information in an appropriate, helpful way.”
As technological advances become increasingly prevalent in medicine, clinical labs will be at the forefront of new initiatives such as the 10-year plan by the NHS.
The Pan American Health Organization has sounded the alarm: non-communicable diseases have surged with relentless force over the past 25 years, painting a grim portrait of a mounting public health crisis.
Non-communicable disease (NCD) deaths have risen by an alarming 43% in the Americas during the last 25 years, according to a recent report released in July by the Pan American Health Organization (PAHO).
A Silent Epidemic: Non-Communicable Diseases Surge Across the Americas
In 2021, NCDs were responsible for 65% of all deaths in the region or 9.2 million people. Almost 40% of these deaths occurred before the age of 70. According to PAHO, the following NCDs led to an increase in deaths:
Cardiovascular disease (2.16 million deaths)
Cancer (1.37 million deaths)
Diabetes (420,000 deaths)
Chronic respiratory conditions (416,000 deaths)
“The surge in NCD deaths is an urgent wake-up call,” stated Jarbas Barbosa, PhD, PAHO Director in a news release. “Too many people are dying prematurely from diseases that are largely preventable and treatable. With early detection, timely diagnosis, access to care, and strong policies, we can save lives. This report gives countries the tools they need to act.”
Jarbas Barbosa, PhD, was elected Director of the PAHO by Member States during the 30th Pan American Sanitary Conference on September 28, 2022, Barbosa began his five-year term on February 1, 2023. (Photo copyright: PAHO)
Risky Behaviors and Environmental Hazards Are Fueling the Crisis
Although population growth and aging are contributing factors to the findings, the PAHO report indicates modifiable risk factors are also driving the rise in NCD deaths. Behaviors such as tobacco use, unhealthy diet, physical inactivity, and harmful alcohol consumption are endangering individuals’ health. The report added that in 2022, there was a 28% increase in obesity since 2010, which affects 33.8% of the adult population in the Americas. Further, the prevalence of diabetes was reported in 13.1% of the population and more than one third of adults have hypertension, but only 36.4% of these cases are controlled.
The report confirmed there are critical environmental challenges contributing to the rise in NCDs, noting air pollution is increasing incidents of cardiovascular and respiratory conditions. It also stated that suicide was the fourth leading cause of death in the 15-29 age group, claiming 100,760 lives. And overall suicide rates have increased by 17.4% since 2000 in the region.
The report also noted there have been some improvements in health trends since 2000, including:
Overall NCD mortality rates decreased by 16.2%
Cardiovascular and chronic respiratory disease mortality rates dropped by nearly 30%
Cancer mortality rates fell by 24.6%
Tobacco use declined by 22.1%
Diabetes treatment coverage rose from 46.6% to 57.7%
Accelerated efforts to battle NCD mortality rates should be considered to improve public health in the Americas. Only five countries—Antigua and Barbuda, Argentina, Barbados, Chile, and Grenada were able to realize the global goal of reducing NCD deaths by 25% before 2025.
Barbosa acknowledges that significant disparities still exist, and critical steps need to be taken to deal with NCDs.
“Only 36% of adults with hypertension are controlled; approximately 38% of adults with diabetes are not adequately treated. Cervical cancer can potentially be eliminated through HPV vaccination, HPV testing, and precancer treatment, all delivered through primary care services. However, coverage rates for HPV vaccination are well below the 90% target, while HPV testing has only been introduced in a few countries,” he said.
Barbosa added that “more than 160 million people live with mental disorders in the Americas, most of whom lack access to care and also experience stigma and discrimination.”
Clinical tests can help identify many of the non-communicable diseases that are responsible for millions of premature deaths. Labs hoping to raise awareness of NCDs among their customers should review the PAHO report to ensure patients receive the best diagnoses and treatments.
UK researchers have identified a link between womb lining issues and recurrent miscarriage, leading to a new test that may help detect risks before pregnancy.
Researchers in the UK have identified a malfunction in the womb lining as a significant contributor to recurrent miscarriages—even when embryos are healthy. The new study entitled “Stalling of the Endometrial Decidual Reaction Determines the Recurrence Risk of Miscarriage,” was published June 25 in the journal Science Advances. The scientists’ findings have led to the development of a new diagnostic tool aimed at identifying women at risk before pregnancy begins.
The study, led by scientists at the University of Warwick, sheds light on a poorly understood biological process called the “decidual reaction,” which prepares the endometrium—the inner lining of the uterus—for embryo implantation.
“This is about identifying preventable miscarriages,” said lead author Joanne Muter, PhD of Warwick Medical School in a press release. “Many women are told they’ve just had ‘bad luck’, but our findings show that the womb itself may be setting the stage for pregnancy loss, even before conception takes place.”
The team analyzed 1,555 biopsies from 1,308 women who sought care at the Implantation Research Clinic at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust. These patients had experienced one or more miscarriages or ongoing fertility issues.
In many of these women, the researchers observed that the decidual reaction did not activate or progress as it should. This disruption results in an unstable uterine environment that still allows embryos to implant but increases the likelihood of early pregnancy loss.
Senior author Jan Brosens, PhD, Professor of Obstetrics & Gynaecology at Warwick and UHCW NHS Trust and Scientific Director of the Tommy’s National Miscarriage Research Centre noted in the press release, “It is well-established that chromosomal errors in embryos account for the rise in miscarriage rates in women older than 35 years. This study shows that each miscarriage increases the risk of an embryo implantation in an abnormal womb, regardless of age.”
“… we now have the tools to screen for the risk of preventable miscarriage and to evaluate treatments that improve the womb lining before pregnancy,” said Senior Author Professor Jan Brosens. (Photo credit: University of Warwick)
“The endometrium’s role is to receive the embryo and support the development of the placenta throughout pregnancy,” the researchers explained in the release. “The decidual reaction transforms the womb lining into a supportive tissue for the embryo to implant.
When it doesn’t fully activate or becomes dysregulated, it creates an unstable environment that, while still allowing embryos to implant, increases the risk of bleeding and early pregnancy loss.”
New Test Measures Womb Readiness and Immune Cell Activity
To detect these abnormalities, the research team developed the Digital Endometrium Function Test—abbreviated as (d)EFT—which is currently undergoing a large-scale pilot trial at UHCW. According to the university, more than 1,000 patients have already received the test as part of their clinical care.
The (d)EFT test requires a small biopsy of the womb lining, according to the Warwick Medical School website. In addition, patients provide a blood sample—used to measure progesterone level—and undergo a transvaginal ultrasound scan. They must also use an ovulation test or wearable device to determine their peak fertility day.
The test evaluates three key markers:
Endometrial readiness: Digital PCR technology measures biomarkers that indicate whether the endometrium can support embryo implantation.
Timing of implantation window: PCR results combined with mathematical modeling determine when the womb lining is most receptive.
uNK cell levels: Digital image analysis measures uterine natural killer cells, which, in abnormal numbers, are linked to IVF failure or increased miscarriage risk.
“High uNK cells are linked to implantation and IVF failure, whereas low levels of uNK cells may increase the risk of miscarriage,” according to the Warwick Medical School website.
The research, funded by UK pregnancy charity Tommy’s, has the potential to shift how clinicians assess and treat miscarriage risk. Current diagnostics often focus on embryo quality, hormone levels, or genetic issues—overlooking the role of the uterine environment.
By offering a more targeted, womb-centered approach, the researchers hope their work will lead to effective new treatments for the estimated 15% of pregnancies that end in miscarriage.
Lead author of a new study, Ciro Chiappini, PhD, says this new technology could lead to advancements in personalized medicine
Scientists at King’s College London have developed a nanoneedle patch that offers a painless alternative to biopsies that also delivers quicker and more accurate results.
As reported by Phys Org, new research published in Nature Nanotechnology shows that these new patches could be the future of diagnostics. As common as traditional biopsies are, they can be painful and often patients are deterred from follow-ups as well as seeking out treatment and early diagnosis.
“We have been working on nanoneedles for twelve years, but this is our most exciting development yet. It opens a world of possibilities for people with brain cancer, Alzheimer’s, and for advancing personalized medicine. It will allow scientists—and eventually clinicians—to study disease in real time like never before.” said Ciro Chiappini, PhD, senior lecturer at King’s College London and lead author of the study.
The lead author of the study, Ciro Chiappini, PhD, senior lecturer at King’s College London said the new development doesn’t disrupt the cell membrane in a way that cannot be repaired. (Photo copyright: King’s College London)
How it Works
The patches are made up of tens of millions of microscopic needles that are 1,000 times thinner than a human hair and do not remove tissue. This causes no damage and pain while the nanoneedles extract molecular fingerprints from the tissue. The sample is then analyzed using both mass spectrometry and artificial intelligence.
“This approach provides multidimensional molecular information from different types of cells within the same tissue. Traditional biopsies simply cannot do that. And because the process does not destroy the tissue, we can sample the same tissue multiple times, which was previously impossible.” said Chiappini of the process. The study focused on lipids and applied the patch to brain cancer tissue of human origin and mice.
Potential Limitations
Additional reporting by Science News looks into some of the possible drawbacks of the technology.
The patch can’t sample tissue that exists deeper in the body, yet Chiappini says that physicians can use the patch during surgery to get fast results on tissue they are operating on. “It’s very much a surface technology, which is potentially [both] a limitation and a feature,” he says.
Phys Org explained the potential during brain surgery. A surgeon would apply a patch to a “suspicious area” and receive results within 20 minutes, providing the surgical team with impactful information in real-time.
Less Pain, More Gain?
It is no secret that patients will often try to avoid or put off uncomfortable medical procedures like biopsies. This new development is part of an ongoing larger trend—making medical procedures more appealing to encourage higher percentages of patients to seek care and receive treatment. As recently reported by Dark Daily in the article entitled, “University of Texas Study Shows Self-Collection Boosts Cancer Screenings among Women,” a new at-home collection kit to replace a traditional Pap smear may help boost early detection of cervical cancer in women.
This new technology and trend toward less painful procedures suggests that patients will be more inclined to participate in pathology exams if they were less invasive and uncomfortable or painful. Pathology professionals should keep on eye on future developments in this space.
Biopsies are not yet ready to become obsolete, as the patch is still in its early stages and more research is needed.
