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

Hosted by Robert Michel

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

Hosted by Robert Michel

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Executive War College 2026 to Spotlight AI, Workforce Solutions, and Financial Strategy for Clinical Labs

Set for April 28–29 in New Orleans, the 31st Annual Executive War College will bring lab leaders together for practical, execution-focused strategies across reimbursement, staffing, compliance, and emerging technologies, with new emphasis on digital pathology and AI-driven operations.

The 31st Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, April 28–29 in New Orleans, will bring together clinical laboratory leaders to address the most pressing challenges shaping the industry in 2026. This year’s event emphasizes practical, execution-focused strategies across financial performance, workforce development, compliance, and emerging technologies.

A key addition to the 2026 program is the inaugural Executive Forum on Digital Pathology Management, a dedicated session exploring digital workflows, artificial intelligence (AI), and data integration. Designed as an interactive and collaborative experience, the forum will highlight real-world implementation strategies and provide attendees with actionable insights into adopting new technologies.

Recently, the Dark Report highlighted what’s to come at the event. Further, Dark Daily reported on key sessions that attendees won’t want to miss.

Six Major Themes Shaping the Industry

The conference agenda is structured around six strategic themes reflecting the evolving laboratory landscape.

  • Financial strategy sessions will focus on improving reimbursement, strengthening payer relationships, and using analytics to drive revenue growth.
  • Workforce discussions will address staffing shortages, automation, and leadership development.
  • Compliance sessions will offer frameworks for managing regulatory risk and embedding compliance into daily operations.
  • Innovation and technology will play a central role, with case studies demonstrating how laboratories can leverage molecular diagnostics, automation, and informatics to enhance clinical value and operational efficiency.
  • AI will receive particular attention, with sessions examining both its opportunities and challenges, including governance, validation, and return on investment.
  • Additionally, experts will explore trends in mergers and acquisitions and strategic partnerships, providing guidance on growth, valuation, and long-term positioning.

Healthcare attorney Elizabeth Sullivan of McDonald Hopkins leads a panel discussion at last year’s Executive War College. Sullivan will return for two sessions at the upcoming 2026 conference. (Photo credit: EWC)

2025 Executive War College Highlights

Workforce challenges persist in 2026 and will again be a key theme at the event. The 2025 Executive War College highlighted several innovative approaches to staffing.

For example, the Dark Report reported on a 2025 Executive War College presentation by Jennifer Fralick, vice president anatomic pathology and clinical laboratories at Stanford Health Care. Fralick noted that clinical labs are addressing severe staffing shortages by focusing on internal talent development through career ladders, training programs, and smarter staffing models that shift routine tasks away from licensed professionals. These strategies improve efficiency, reduce burnout, and help labs build sustainable, long-term workforce pipelines instead of relying solely on external hiring. (Fralick is returning to this year’s event to discuss an AI playbook for labs.)

Operational solutions will also be highlighted in the 2026 agenda. Last year, as the Dark Report noted in an article, Shashirekha Shetty, PhD, professor in the Department of Pathology at  Case Western University, presented on how up to 70% of laboratory errors occur in the pre-analytical phase, often due to incorrect test orders, improper sample handling, and poor communication, making it a major risk to patient care and lab efficiency. Shetty emphasized that labs must take full ownership of this phase by implementing standardized workflows, strengthening training and collaboration with clinicians, and embedding pre-analytic quality into their overall quality management systems.

Attendees can expect updated solutions for these challenges and more presented by experts at this year’s Executive War College, which is just a short month away. With nearly 80 sessions and around 150 speakers, the program is designed to equip attendees with practical tools, real-world case studies, and operational playbooks. Laboratory executives will leave with clear, actionable roadmaps to navigate financial pressures, regulatory scrutiny, and rapid technological change.

—Janette Wider

Industry Innovators to Reveal High-Performance Strategies at 31st Annual Executive War College

From MD Anderson’s workforce pillars to NYU Langone’s digital pathology overhaul, the 2026 Executive War College speaker spotlight highlights the “boots-on-the-ground” experts set to reveal how labs can navigate reimbursement pressure and regulatory shifts this April in New Orleans.

As clinical laboratories face a “perfect storm” of reimbursement pressure, workforce shortages, and shifting regulatory mandates, the upcoming Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management (April 28-29, 2026) has released its first wave of speaker spotlights. The 2026 agenda will focus on “early-adopter” case studies that demonstrate how labs can stop merely keeping pace to instead set new standards in innovation.

Speaker Highlights: Driving Financial and Operational Resilience

Among the key thought leaders taking the podium are experts focused on the high-stakes intersection of clinical quality, workforce stability, and bottom-line profitability.

  • Walter McAndrew, MB(ASCP), SSGB, molecular diagnostics laboratory manager at MD Anderson Cancer Center
    • McAndrew will detail a high-impact case study on workforce stability. In an era of rampant burnout and reliance on expensive traveler staff, McAndrew will demonstrate how MD Anderson re-engineered its molecular operations to better drive measurable quality while simultaneously reducing costs.
  • Jonathan Burgart, director of US marketing at Abbott Core Diagnostics
    • Burgart is set to challenge the “cost-center mindset” that plagues many hospital-based laboratories. His session will provide a strategic framework for hospital executives to use excess capacity and operational data to improve  operating margins and net income.
  • Christina Olesnycky and Syed T. Hoda, MD, NYU Langone Health
    • Leading the shift toward high-volume automation, the two speakers will share the roadmap NYU Langone used to achieve a full digital pathology workflow in just one year. Their presentation will highlight how pathology at scale accelerates diagnosis and provides a necessary foundation for AI-enabled innovation.
  • Stefanie Davidson, laboratory director at Foundation Health
    • Davidson will share proven workforce strategies that help laboratories break their dependency on temporary staffing and achieve long-term operational stability.

Executive War College 2025. Photo credit: EWC

Why It Matters for Lab Leaders

The 2026 program arrives at a critical strategic tipping point as laboratories move from a period of regulatory uncertainty into a year of mandatory execution. With the expiration of legislative moratoriums on PAMA reporting and the shift toward a post-LDT ruling reality, the margin for operational error has effectively disappeared. This year’s sessions move beyond high-level theory to address the hurdles of 2026: navigating the “regulatory cliff,” defending shrinking margins against a surge in federal audit activity, and transitioning AI and digital pathology from expensive pilot projects into essential, everyday workflows.

“The laboratory has the potential to reframe its role in the healthcare system,” noted Burgart, emphasizing that this year’s sessions will provide the specific financial and operational blueprints required to turn regulatory challenges into a sustainable competitive advantage.

About the Event

The 31st Annual Executive War College will be held at the Hyatt Regency New Orleans. It remains the largest gathering of lab and pathology leaders focused exclusively on the business and management of diagnostic medicine.

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

—Janette Wider

At the AMP 2025 Annual Meeting, Hundreds Jam Room to Hear About cfDNA Testing

Association for Molecular Pathology gathering also served up an advocacy push for RESULTS Act passage.

The Association for Molecular Pathology (AMP) 2025 Annual Meeting brought together just over 3,000 attendees, and an estimated 420 of them—an impressive 14% of total attendance—sought out information about cell-free DNA (cfDNA) testing.

Walking through the convention center in Boston that hosted AMP 2025 earlier this month, it was hard to ignore the standing-room only crowd that jammed into a session room to hear more about cfDNA diagnostics.

Cell-free DNA comprises fragments of DNA circulating in the blood, either from dying cells or infection. For clinical laboratory professionals and pathologists, cfDNA testing sits at the forefront of innovation for detecting cancer.

“We want to find these cancers early,” said presenter Trevor Pugh, PhD, a senior scientist at Princess Margaret Cancer Centre in Toronto and director of genomics at the Ontario Institute for Cancer Research.

At the AMP 2025 Annual Meeting in Boston, a session about cfDNA testing attracted more than 400 attendees. (Photo credit: Scott Wallask)

Machine Learning Will Play a Role in cfDNA Research

Part of the effort to advance cfDNA testing will involve datasets and mining, Pugh said. For example, one of his graduate students is working with him on training a cfDNA foundation model, which could lead to the ability to reconstruct the complete cancer genome.

“This is a machine learning person’s dream,” Pugh explained.

Foundation models are artificial intelligence (AI) networks trained on large datasets. The models allow for more specialized applications, such as those that can analyze digital diagnostic images.

AMP Pushes for Passage of the RESULTS Act

Elsewhere at the AMP 2025 conference, the association provided an update on delayed lab test reimbursement cuts under the Protecting Access to Medicare Act of 2014 (PAMA). Organizers also addressed the latest attempt to reform PAMA, the proposed Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act.

As Dark Daily previously reported, momentum for the RESULTS Act is growing. Congress delayed upcoming PAMA cuts from Jan. 1, 2026, to Jan. 30, 2026, and there is hope during this brief extension that the RESULTS can get a vote or least greater support among lawmakers.

AMP endorses the RESULTS Act. “Congress needs to act,” said Jay Patel, MD, MBA, a member of AMP’s board of directors, during the PAMA update.

AMP has asked the Centers for Medicare and Medicaid Services to delay PAMA-related reporting requirements for labs until Congress can vote on the RESULTS Act, Patel added.

AI Featured in AMP 2025 Poster Sessions

More than 500 posters presentations occurred during AMP 2025. The space to house that many posters took up nearly half of the exhibition hall allotted to AMP.

The association noted several poster sessions that centered on how AI is improving diagnostic processes and accuracy within molecular pathology:

  • Researchers from The Hospital for Sick Children developed a web-based AI platform to integrate RNA sequencing into clinical workflows. The model achieved 93% diagnostic accuracy on subtypes covered by the platform.
  • Scientists at Soonchunhyang University created two AI models to classify samples. Both models showed strong accuracy.
  • Researchers at Wake Forest University School of Medicine used an AI-trained algorithm to analyze chromosomal abnormalities in GATA2 deficiency syndrome-related leukemia. The technology can quickly review hundreds of images, improving detection.

Members of our sibling brand, The Dark Report, can read more about the state of AI in clinical labs in our three-part series.

—Scott Wallask

Roche and Partners Push Sequencing Boundaries with Record-Breaking SBX Technology

Roche’s SBX technology just helped Broad Clinical Labs set a GUINNESS WORLD RECORD for the fastest DNA sequencing ever.

According to a recent press release, for laboratory leaders tracking the next wave of genomic innovation, Roche’s latest advancements in sequencing technology could signal a major shift in research capabilities. At the 2025 American Society of Human Genetics (ASHG) Annual Meeting, the company unveiled new data and collaborations around its Sequencing by Expansion (SBX) platform—a system designed to deliver faster, longer, and more flexible reads.

This technology’s growing adoption by research institutions suggests it could soon reshape how labs approach complex multiomic analysis, precision oncology, and translational research.

World Record Broken

A highlight of the 2025 ASHG Annual Meeting was the GUINNESS WORLD RECORD achievement by Broad Clinical Labs, which used SBX to complete the fastest human genome sequencing to date, processing a sample from DNA extraction to final variant call file in under four hours. This record, achieved in collaboration with Roche Sequencing Solutions and Boston Children’s Hospital, surpassed the previous mark of just over five hours, demonstrating SBX’s ability to deliver rapid, high-quality results.

Mark Kokoris, inventor of the SBX chemistry and head of SBX Technology at Roche said, “The true impact lies in what this speed and accuracy mean for the scientific community and for deciphering complex diseases like cancer and neurodegenerative conditions.”

Mark Kokoris, inventor of the SBX chemistry and head of SBX Technology at Roche commented, “Breaking the GUINNESS WORLD RECORD is a remarkable achievement.” (Photo credit: Roche)

Roche also announced a new collaboration with the Wellcome Sanger Institute, which will conduct multi-project evaluations of SBX across applications such as Bulk RNA sequencing, where longer reads and higher throughput could uncover complex features like spliced isoforms. This partnership adds to a growing network of collaborations that include the Hartwig Medical Foundation, Genentech, The University of Tokyo, and the Broad Institute, reflecting widespread scientific interest in applying SBX across diverse research domains.

Further innovations include progress in methylation mapping using SBX-Duplex, which reads both DNA strands simultaneously, paired with TET-assisted pyridine borane sequencing (TAPS) from Watchmaker Genomics. This workflow enhances accuracy in detecting DNA methylation and holds promise for applications such as liquid biopsy-based cancer detection and novel biomarker discovery.

In another collaboration, researchers at the University of Tokyo leveraged SBX’s speed and flexibility for spatial sequencing of lung cancer tissue, achieving roughly 15 billion reads in just one hour. Roche also presented a target enrichment method using the SBX-Simplex workflow, which employs Unique Molecular Identifiers (UMIs) to generate highly accurate reads from minimal input, an approach that could be particularly valuable in oncology research requiring deep sequencing coverage.

For diagnostics and research laboratories, Roche’s progress with SBX represents more than a technical milestone, it points to new operational opportunities. Potentially faster turnaround times, deeper insights across multiple molecular layers, and improved workflows could help labs expand their research portfolios and strengthen partnerships in precision medicine. As sequencing continues to evolve from discovery to real-world application, forward-thinking lab leaders will want to keep an eye on how SBX’s scalability and speed might redefine their own genomic testing strategies.

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

—Janette Wider

Doctors Say Clinical Labs Are Indispensable, but System Pressures Threaten Collaboration

Nearly all doctors call lab testing essential, but shortages and patient pressures are putting the system to the test.

Physicians across the United States certainly recognize the indispensable role of clinical laboratory testing in patient care, but growing workforce shortages, financial pressures, and rising patient demands are straining the system, according to a new survey conducted by YouGov on behalf of Siemens Healthineers.

The survey was released on July 29, during the Association for Diagnostics & Laboratory Medicine (ADLM) conference in Chicago.

The Dark Daily recently covered how findings at ADLM showed digital pathology trends are being slowly adopted in the US but how there’s a larger movement to connect patient care more directly.

The survey of 408 physicians, along with a parallel poll of 1,000 patients, reveals both how deeply doctors depend on laboratory professionals and how external pressures are reshaping testing decisions.

“Ninety-nine percent of physicians agree clinical lab testing is an integral part of the healthcare system,” the report states. Nearly all respondents said lab results are vital in informing treatment choices, with 98% noting they had modified a diagnosis or care plan based on test outcomes. As one physician put it, lab tests “help determine my actions” by providing crucial clarity in uncertain cases.

Doctors also reported that laboratory insights streamline the use of other healthcare resources. “Together, we help the health system and avoid unnecessary patient interventions,” one physician said, noting how test results often reduce the need for additional imaging or biopsies. In fact, 100% of surveyed physicians agreed that lab data helps them use other healthcare tools more effectively.

The Growing Strain on Labs

Despite reliance on labs, the collaboration doctors depend on is increasingly at risk. Clinical laboratory professionals manage more than 80,000 different tests across US facilities and generate roughly 14 billion results annually. Yet the workforce supporting this output is shrinking.

“When labs are short-staffed, it has a downstream effect on patient care,” 96% of doctors agreed. Another 94% expressed concern about healthcare staffing shortages more broadly. The problem is particularly acute in laboratories, where the number of training programs has dropped below 250 nationwide, leaving only about one lab scientist per 1,000 Americans.

Financial pressures are compounding the workforce issue. Though lab services account for only 4% of hospital costs, they are frequently targeted for cost-cutting. Consolidation and outsourcing have moved testing away from local facilities and toward centralized “dark labs,” largely operated by automation. While these high-tech labs maintain throughput, physicians caution that automation cannot replace collaboration. “In the age of automation, the human collaboration physicians depend on still counts,” the report warns.

Patient Demands Reshape Testing

Physicians are also feeling pressure from patients, many of whom arrive armed with information—or misinformation—from the internet. This rising “patient agency,” defined as the ability to influence healthcare decisions, is reshaping physician-patient interactions.

“Patient requests have forced me to weigh patient satisfaction against clinical judgment,” one physician admitted. Survey data shows 84% of patients expect their doctors to order requested tests, while 76% of physicians acknowledged ordering labs simply to satisfy those requests.

Zobair Younossi, MD, MPH, chairman, The Global NASH/MASH Council, said, “As a hepatologist dedicated to enhancing liver disease care, I believe that advances in laboratory testing are enabling us to ‘move the needle’ from liver biopsy toward blood-based biomarkers, allowing for earlier intervention through less invasive methods. For this shift to be successful, collaboration between clinicians and laboratory professionals is essential.” (Photo credit: MASH Alliance)

At the same time, 90% of patients said they trusted their doctor’s recommendation if the physician advised against unnecessary tests. Still, the survey underscores tension: while exploratory testing may placate patients, it can also create unnecessary costs and confusion. “Laboratory testing may be somewhat mitigating, though it can add unnecessary volume and expense for already overburdened clinical laboratories,” the report cautions.

The Hidden Role of Cost and Bureaucracy

Physicians also report external bureaucratic and financial pressures influencing test orders. About 32% said they had faced directives to reduce testing, while only 37% had visibility into the cost of lab tests they ordered. That number dropped further when asked about insurance coverage.

“Inadequate healthcare coverage may prevent patients from getting the appropriate level of laboratory testing,” the report notes. Among doctors who do know test costs, 60% admitted delaying orders due to expense concerns. From the patient side, 29% of respondents reported unpaid medical bills, with more than half saying their debt included lab testing fees.

Physicians are caught between avoiding unnecessary spending and protecting themselves from malpractice risk. Nearly 70% cited fear of being sued for misdiagnosis as a top concern, and 92% said they consider whether lab testing might reduce that risk. As one doctor put it, “Errors that negatively impact a patient’s care weigh heavy on my conscience and affect my mental health.”

A Call for Stronger Collaboration

Despite these pressures, doctors remain clear on their priorities. “Ninety-five percent agree that ordering tests to validate a patient’s care plan is their priority over conserving resources,” the report found. To achieve that, physicians want stronger ties with clinical lab professionals.

More than half—55%—said they heavily rely on lab experts to confirm which tests are most relevant, while 96% said they welcomed feedback from laboratory colleagues to improve ordering practices. “Physicians say clinical laboratory professionals are essential partners in delivering high-quality patient care, but a shrinking laboratory workforce may threaten the collaboration doctors rely on for clinical clarity,” the report concludes.

The Future of the Lab

Looking ahead, the report raises the question of whether the rise of automation-heavy dark labs will be a temporary solution or a permanent shift. For many doctors, the fear is losing the human expertise that helps interpret increasingly complex test menus.

“What physicians want are clinical partners and greater access to skilled professionals whose clinical insights help inform their patient care decisions,” the report states.

Without reinvestment in labs and workforce development, patients may face longer wait times, higher costs, and reduced trust in the system.

Ultimately, both doctors and patients recognize the centrality of the lab. The challenge now, as the survey shows, is ensuring those professionals are supported. “Recognizing laboratory professionals as collaborative clinical partners, and resourcing clinical labs as essential infrastructure rather than cost centers, is vital to safeguarding the important clinical support physicians rely on,” Siemens Healthineers concluded.

—Janette Wider

Digital Pathology Trends Show Slow Adoption in US but Also Movement to Connect to Patient Care More Directly

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.

—Scott Wallask

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