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.
Rapid adoption of automated storage systems in clinical and research labs is expected to support a compound annual growth rate of 11.1% through 2034.
As clinical laboratories push for greater efficiency in their processing of blood, urine, and tissue samples, research firm Global Market Insights (GMI) projects massive growth in the international market for automated systems used to safely store and retrieve these samples as well as chemical compounds used in drug discovery and research.
Key Growth Drivers: Biobanking, AI Integration, and Lab Digitalization
The market for automated sample storage systems in life sciences will grow from an estimated $1.3 billion in 2024 to $3.6 billion in 2034, a compound annual growth rate (CAGR) of 11.1%, GMI stated in a July 2025 report.
“This high growth is attributed to several factors including the growing need for biobanking and maintaining biorepositories, digital transformation across clinical and research laboratories, growth in drug discovery and development, and growing focus on sample integrity and compliance,” GMI stated in a summary of the report.
Market Breakdown: Compound vs. Biological Sample Storage
The market includes a wide range of products used to manage sample storage and retrieval in healthcare, medical research, and drug development. Systems used to store, track, and retrieve chemical compounds accounted for nearly 60% of the market in 2024, with pharmaceutical companies as the primary drivers. Systems used to manage biological samples amounted to approximately 30% of the market.
The report identifies several key factors that are driving this growth. Among them, an increase in the number of biobanks and high-throughput genomic research programs is “significantly driving the growth in sample volumes,” GMI noted. “This trend is boosting the demand for scalable automated storage systems in laboratories.”
Photo copyright: Artem Podrez
Other drivers include new technologies such as artificial intelligence (AI). GMI noted that these systems are increasingly deploying AI “to automate sample identification, optimize retrieval processes, and reduce errors.” In addition, labeling techniques such as radio frequency identification and 2D barcodes “have minimized manual intervention while decreasing human mistakes to allow quicker inventory assessments and enhanced traceability,” GMI stated.
However, GMI also noted challenges that could hinder market growth, including high upfront costs and questions about data security.
Regional Trends and Leading Companies in Sample Storage Automation
North America currently boasts the largest market for these systems, an estimated $533.3 million in 2024, GMI reported. However, the Asia Pacific region will see the highest CAGR, growing at a rate of 11.9% through 2034.
GMI identified Brooks Automation as the market leader with a 20% share in 2024. The company’s product line includes PathFinder systems designed to automate management of biological samples in pathology labs, such as sorting, decapping, sealing, and archiving of specimens.
Interestingly, the report noted several recent developments involving Hamilton Company, including a 2024 deal with Platomics to register its liquid handling systems with the latter’s PlatoX regulatory platform. This will make it easier for clinical labs in the EU to comply with the region’s In Vitro Diagnostic Regulation (IVDR) when deploying internally developed tests, the companies stated in a press release.
The market, estimated at $1.02 billion in 2024, will grow to $3.12 billion by 2034, a CAGR of 11.9%, the company said.
The report noted many of the same growth drivers—and challenges—identified by GMI. Drivers include technological advancements as well as the growth of personalized medicine and the need for long-term sample preservation for research related to cancer, cardiovascular, and neurological disease.
“The automated biobanking market is on the cusp of a revolution, not only enhancing the speed and precision of sample management but also enabling cross-border biomedical collaboration, rare disease research, and pandemic preparedness,” the company stated in a press release. “As personalized medicine and digital health accelerate, investments in smart biorepositories will become foundational to innovation in diagnostics, drug discovery, and population health.”
Hospital laboratories are likely to see an increase in test orders for bacteria-borne infections, such as tuberculosis
The tuberculosis outbreak in Kansas City, Kan., is one of the largest in the US within a one-year period over the past several decades. Hospital laboratories are the front line for detecting these types of infectious diseases.
As of June 6, 2025, the number of reported active cases of tuberculosis (TB) since 2024 was 69 with 62 cases in Wyandotte County and seven cases in nearby Johnson County, both in Kansas, according to the latest available data as of this writing from the Kansas Department of Health and Environment.
An active TB infection is one in which patients are symptomatic, in need of immediate treatment, and contagious. These patients have typically had a positive TB blood or skin test and may have had an abnormal chest x-ray or positive sputum smear or culture.
The latest statistics show there are 97 cases of latent TB infections reported in the same counties. Latent TB infections are those where patients are asymptomatic but have had a positive TB test, a normal chest x-ray, and a negative sputum smear.
Although individuals with latent infections cannot transmit the illness to others, these cases may become active without treatment, rendering them potentially dangerous.
“You can think of TB outbreaks like a canary in the coalmine of our public health infrastructure,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “What causes them to happen is a weakening of our public health infrastructure.” (Photo copyright: Johns Hopkins Medicine.)
Cause of Outbreak Remains Unknown
This TB outbreak was first identified in Kansas last year and its origin is unknown. Two people have died from the infection, but the risk to the public remains low.
“It’s definitely more than just a little blip,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “It’s one of the largest outbreaks of tuberculosis that we’ve seen in the country in the past 30, 40, 50 years.”
TB in humans can be caused by two types of mycobacteria: Mycobacterium tuberculosis and Mycobacterium bovis. The former is the most common cause of the disease. The pathogen is airborne and is transmitted via respiratory droplets produced by coughing, sneezing, or speaking.
TB usually attacks the lungs, but other parts of the body can be affected as well. According to the Centers for Disease Control and Prevention, symptoms of the disease include:
Cough that lasts more than three weeks.
Coughing up blood or sputum.
Fever and chills.
Loss of appetite.
Weight loss.
Night sweats.
Weakness or fatigue.
Chest pains.
Each patient in the Kansas outbreak has been screened and contact traced. Testing is being provided free of charge. TB is treatable via antibiotics, and more than 85% of infected individuals fully recover with treatment.
TB is Relatively Common
Although curable and preventable, TB is one of the world’s deadliest infectious diseases. According to the World Health Organization, an estimated 10.8 million people contracted TB in 2023, and 1.25 million people died from the disease that year. Fewer than 10,000 of the cases occurred in the US.
“I think the first misconception about TB is that it’s a rare and uncommon disease. We think of it as something that doesn’t really impact us anymore in 2025, but TB has been here, is here, and it’s something that’s relatively common,” said Michael Bernstein, MD, director of pulmonary and critical care at Stamford Health, Stamford, Conn., in the American Journal of Managed Care. “So, the fact that we would see a TB outbreak doesn’t surprise most pulmonologists.”
Clinical laboratories should monitor localized TB outbreaks as they are at the forefront for testing and detecting infectious diseases. Hospital labs may want to prepare for an upsurge in patients arriving with tuberculosis and other bacterial infections in the future.
NPR reports that the shamed Theranos founder/CEO is providing advice to Evans, but the startup denies that claim
Prison bars can’t block Elizabeth Holmes from finding her way back into the news spotlight. The disgraced founder and former CEO of Theranos is reportedly advising her partner Billy Evans on his new artificial intelligence (AI) diagnostic startup company, named Haemanthus after the blood lily.
According to sources who spoke with NPR, Evans’ new company Haemanthus, Inc. is developing a blood testing device and has patented a process that uses Raman spectroscopy, which, according to NPR, “has been shown to help diagnose ALS, also called Lou Gehrig’s disease, as well as some forms of cancer. It has also been used to discover improvised explosive devices on battlefields.”
Evans has already raised millions of dollars for the fledgling startup, NPR reported, adding that a source claimed finances for the company have come from “mostly friends, family, and other supporters so far.”
According to Newsweek, Evans’ goal is to raise $50 million toward the development of a “medical testing product.”
The company will “do medical tests using bodily fluids,” Newsweek reported, adding, “An image of the alleged device published by The New York Times is eerily similar to Theranos’ ‘Edison’ testing machine.”
Elizabeth Holmes is currently housed in a federal facility in Bryan, Texas. Sources told NPR that she has been “providing advice” to Billy Evans, her partner, on his new AI/medical testing company Haemanthus, which denied those claims stating on X that Holmes “has no role, now or future.” (Photo copyright: Wikimedia Commons.)
Haemanthus Denies Holmes’ Involvement
Holmes has reportedly been providing insight to Evans throughout her prison term, though her role with his budding company is unclear, NPR noted.
As previously reported by Dark Daily, Holmes is “barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the healthcare sector.”
Haemanthus denied Holmes’ involvement with the company, claiming that she “has no formal role” and that “Haemanthus is not Theranos 2.0,” Fortune reported.
Previous lengthy posts by Haemanthus on social media platform X fully denied any involvement with Holmes but have since been deleted. The company now uses their platform to curtly retort the significance of Holmes’ involvement, leaning on their advancements and high standards. “Skepticism is rational. We must clear a higher bar,” they said. “When The NY Times contacted us, we invited them to see our lab, tech, and team. They declined. The headline was already written. Our reality inconvenient.”
Further posts on X showcase Haemanthus’ desire to have the same groundbreaking prowess Holmes clung to throughout her Theranos venture. The company claims to have developed “the world’s first AI-native sensors for health,” adding, “Our technology captures thousands of biomarkers simultaneously.”
And the Holmes Saga Continues
Haemanthus is comprised of about a dozen people, including individuals who “worked with Evans at Luminar Technologies, which develops sensor technology for autonomous vehicles, according to the company’s patent and Delaware incorporation paperwork,” NPR reported.
Holmes is currently serving an 11-year federal prison sentence for her role in fraud involving Silicon Valley startup Theranos, which boasted clinical laboratory blood-test breakthroughs that turned out to be riddled with faulty equipment and fraudulent results.
Though whistleblowers brought Holmes scheme to the light, she has never admitted wrongdoing for her actions and continues to claim her innocence. In May, the Ninth Circuit of Appeals denied her request for a rehearing of her case.
Findings may lead to new clinical laboratory testing and treatments for Parkinson’s patients
Gut bacteria have repeatedly been proven to perform critical roles in the development of certain diseases. And many clinical laboratory tests use human microbiota as biomarkers.
Now, researchers at Nagoya University Graduate School of Medicine in Japan have discovered a link between microbes in the gut and the brain. The connection may play a part in the development of Parkinson’s disease, according to a Nagoya University news release.
The researchers found that a reduction in the genes responsible for synthesizing riboflavin (vitamin B2) and biotin (vitamin B7) may increase the likelihood of developing Parkinson’s.
They also determined that the lack of these genes may lessen the integrity of the intestinal barrier that prevents toxins from entering the bloodstream causing the inflammation often seen in Parkinson’s patients.
“Supplementation therapy targeting riboflavin and biotin holds promise as a potential therapeutic avenue for alleviating Parkinson’s symptoms and slowing disease progression,” said lead researcher Hiroshi Nishiwaki, PhD, Division of Neurogenetics, Center for Neurological Diseases and Cancer, Nagoya University Graduate School of Medicine, in a news release. (Photo copyright: Nagoya University.)
Key Deficiencies in Parkinson’s Patients
According to the Parkinson’s Foundation, nearly one million people in the US are living with Parkinson’s and that number is expected to increase to 1.2 million by the year 2030. Approximately 90,000 new cases of Parkinson’s are diagnosed in the US each year, and more than 10 million people are living with the disease worldwide.
To perform their research, the Nagoya University team analyzed stool samples from 94 Parkinson’s patients from Japan, the US, Germany, China, and Taiwan. They also included 73 relatively healthy controls from Japan. They then used shotgun sequencing (a laboratory technique for determining the DNA sequence of an organism’s genome) to gain a better understanding of the microbial community and genetic makeup of each sample.
The scientists discovered a decrease in B2 and B7 vitamins in patients diagnosed with Parkinson’s. B vitamins promote the production and functions of short-chain fatty acids (SCFA) and polyamines.
“Supplementation of riboflavin and/or biotin is likely to be beneficial in a subset of Parkinson’s disease patients, in which gut dysbiosis plays pivotal roles,” the authors wrote in NPJ-Parkinson’s Disease.
The examination of fecal metabolites in Parkinson’s patients revealed a reduction in both components.
“Deficiencies in polyamines and SCFAs could lead to thinning of the intestinal mucus layer, increasing intestinal permeability, both of which have been observed in Parkinson’s,” said Hiroshi Nishiwaki, PhD, a professor at Nagoya University Graduate School of Medicine and a lead researcher for the study, in the news release.
“This higher permeability exposes nerves to toxins, contributing to abnormal aggregation of alpha-synuclein, activating the immune cells in the brain, and leading to long-term inflammation,” he added.
The team surmises that the weakened protective layer in the gut exposes the intestinal nervous system to more of the toxins people experience in everyday life, such as chemicals, pesticides, and herbicides. These types of toxins lead to the overproduction of alpha-synuclein fibrils. These molecules are aggregates of the α-synuclein protein that form into long, thread-like structures which are primarily found in the brains of individuals with neurodegenerative diseases like Parkinson’s.
Alpha-synuclein fibrils amass in dopamine-producing cells in the brain and increase the type of inflammation that leads to the debilitating motor skills and dementia symptoms of Parkinson’s.
Precision Medicine Analysis Suggested
Due to their research, the team proposes that high doses of vitamin B may help reduce the damage of toxins on the gut microbiome, help protect against neurodegenerative diseases like Parkinson’s, and aid in the creation of personalized therapy plans for patients.
“We could perform gut microbiota analysis on patients or conduct fecal metabolite analysis,” Nishiwaki noted. “Using these findings, we could identify individuals with specific deficiencies and administer oral riboflavin and biotin supplements to those with decreased levels, potentially creating an effective treatment.”
The results of the Nagoya University study illustrate the importance of a healthy gut microbiome in the prevention of disease. Altering the bacterial level in the gut may enable doctors to stave off the progression of neurodegenerative illnesses like Parkinson’s disease.
Artificial intelligence tools for radiology, clinical laboratory, and pathology diagnostics continue to advance and improve
Researchers in Germany have developed a fully automated, artificial intelligence (AI) tool that improves the diagnosis of prostate cancer. Developed by mediaire, a company that creates AI-based tools for radiologists, the software reduces clinical workloads and could be beneficial in counteracting issues associated with variability in magnetic resonance imaging (MRI) reporting. This is another example of AI’s growth in the clinical diagnostic industry, including clinical laboratory and pathology medicine.
The software, called mdprostate, has received the mandatory certification mark (CE or European Conformity) for products sold within the European Economic Area (EEA). It is now commercially available in those countries and was recently incorporated into the picture archiving and communications system (PACS) of some healthcare organizations and applied to a group of patients who had undergone a multiparametric prostate MRI (mpMRI).
The goal was to compare the overall performance of mdprostate against radiologists who executed the initial interpretations of the mpMRIs, according to Health Imaging.
“Mdprostate is intended to support radiologists by automating time-consuming processes and improving the objectivity of diagnosis through data quantification,” said Tonia Michaely, chief of staff at mediaire, in a news release.
“By providing objective assessments and standardizing lesion detection and classification, AI has the potential to augment radiologists’ performance throughout the PCa [prostate cancer] diagnostic pathway,” Nadine Bayerl, Dr. med., a radiologist with the Institute of Radiology at University Hospital Erlangen and corresponding author of the mediaire study, told Health Imaging. (Photo copyright: University Hospital Erlangen.)
Scoring Cancer Risk
To perform the comparison, a team of researchers applied the AI tool to 123 prostate MRI exams followed by systematic and targeted biopsies. The software was instructed to automatically segment the prostrate, calculate prostate volume, and classify lesions per the Prostate Imaging Reporting and Data System (PI-RADS).
PI-RADS, according to the America College of Radiology, is a reporting method that indicates how likely a lesion is to be clinically significant cancer on a score of one to five:
PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present).
PI-RADS 2: low (clinically significant cancer is unlikely to be present).
PI-RADS 3: intermediate (the presence of clinically significant cancer is equivocal).
PI-RADS 4: high (clinically significant cancer is likely to be present).
PI-RADS 5: very high (clinically significant cancer is highly likely to be present).
For PI-RADS scores greater than two, mdprostate generated 100% sensitivity and dismissed all cancers for lesions that were below that threshold. For PI-RADS scores of four or higher, the AI tool yielded 85.5% sensitivity and specificity of 63.2% for clinically significant cancers.
Deep Learning in Diagnostic Pathway
“In practical terms, these results indicate that when a case falls below the PI-RADS ≥ 2 cutoff, clinicians can rule out malignancy with a high degree of confidence,” the authors explained in the European Journal of Radiology. “This capability is particularly valuable in clinical decision-making, as it allows for the safe avoidance of unnecessary biopsies or further invasive procedures in these patients.”
“Recent advances in deep learning algorithms, facilitated by larger labeled datasets, improved computing hardware, and refined training techniques, have led to several studies highlighting the diagnostic value of deep learning algorithms in prostate imaging,” radiologist Nadine Bayerl, Dr. med., Institute of Radiology at University Hospital Erlangen and corresponding author of the study, told Health Imaging.
The software “demonstrated high diagnostic performance in identifying and grading prostate lesions, with results comparable to those reported in meta-analyses of expert readers using PI-RADS,” the researchers noted in their published study.
“Its ability to standardize evaluations and potentially reduce variability underscores its potential as a valuable adjunct in the prostate cancer diagnostic pathway. The high accuracy of mdprostate, particularly in ruling out prostate cancers, highlights its clinical utility by reducing workload and enhancing patient outcomes,” they concluded.
AI in Clinical Laboratories and Pathology
Dark Daily has frequently covered AI’s expanding role in clinical laboratory testing and pathology diagnostics. At the recent Executive War College, a dozen sessions explored its growth in the industry. During one session, Sam Terese, CEO and president at Alverno Laboratories said, “AI is allowing us to drive our business. It is really resonating that we need to use AI in the future.”
Members who could not attend the 2025 Executive War College can order audio recordings of these valuable sessions by clicking here.
