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

Hosted by Robert Michel

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

Hosted by Robert Michel

Sign In

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

Clinical Labs May Gain New Edge in Early Cancer Detection with Epigenetic Instability Liquid Biopsy

Johns Hopkins researchers show that measuring DNA methylation variability can improve early cancer detection accuracy and strengthen liquid biopsy performance across diverse patient populations.

Researchers at Johns Hopkins Kimmel Cancer Center are advancing a new approach to liquid biopsy that could improve early cancer detection by focusing on variability in DNA methylation patterns—rather than absolute levels—offering a potentially more reliable biomarker across diverse patient populations.

Dark Daily’s sibling publication Today’s Clinical Lab reported that the liquid biopsy market is expected to increase by approximately 20% between 2022 and 2032, noting early cancer detection as a driver of the increase.

The method introduces a novel metric called the Epigenetic Instability Index (EII), designed to measure random variation, or “stochasticity,” in DNA methylation. In a proof-of-concept study published in Clinical Cancer Research, the approach demonstrated strong performance in distinguishing patients with early-stage cancers from healthy individuals.

“This is the first study where we are trying to really implement measuring that variation, or stochasticity, into a diagnostic tool,” said lead author Hariharan Easwaran, PhD. “We immediately found that measuring DNA methylation variation performs better than just measuring DNA methylation by itself.”

Model Targets Methylation Variability to Improve Multi-Cancer Detection

Traditional methylation-based liquid biopsies typically rely on detecting fixed changes at specific genomic sites. However, those tests are often developed using narrow patient cohorts and can struggle to generalize across broader populations. By contrast, the EII approach aims to capture a more universal biological signal tied to early tumor development.

To build the model, researchers analyzed more than 2,000 publicly available DNA methylation samples and identified 269 genomic regions (CpG islands) that capture the majority of methylation variability across cancer types.

“We identified specific genomic regions that tend to be the most variable in DNA methylation marks during cancer,” said first author Sara-Jayne Thursby, a postdoctoral researcher in Easwaran’s lab. “In cell-free DNA in the blood, that variability shouldn’t be high, but if it is, it is indicative of a developing cancerous phenotype.”

Using these regions, the team trained a machine learning model that demonstrated high accuracy across multiple cancers. In lung adenocarcinoma, the test detected stage 1A disease with 81% sensitivity at 95% specificity. For early-stage breast cancer, sensitivity reached approximately 68% at the same specificity level. The tool also showed potential utility in colon, pancreatic, brain, and prostate cancers.

Researchers say the findings support the idea that epigenetic instability may be an early hallmark of cancer progression.

“We hypothesize that early-stage tumors and precancerous lesions that exhibit high degrees of methylation variation… may be more resistant to intrinsic cancer-protective mechanisms and progress more rapidly,” said co-lead author Thomas Pisanic, PhD.

Looking ahead, the team plans to further validate the EII in larger clinical studies and position it as a complementary tool alongside existing screening methods. Easwaran noted that the test could serve as a “secondary triaging measure,” helping clinicians determine whether follow-up procedures—such as biopsies—are necessary after inconclusive or false-positive screening results.

For clinical laboratories, the approach signals a growing shift toward more nuanced, data-driven biomarkers that may improve early detection while reducing unnecessary procedures.

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

—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

Vitestro Raises $70M to Advance Robotic Phlebotomy as Labs Confront Workforce Pressures

New funding will help Vitestro expand clinical validation, scale manufacturing, and prepare its autonomous blood-draw technology for broader hospital and laboratory adoption.

Vitestro has secured $70 million in oversubscribed Series B financing to accelerate development and commercialization of its Aletta Autonomous Robotic Phlebotomy Device (ARPD), a platform designed to automate routine blood collection in clinical settings.

In March 2025, The Dark Report reported on Vitestro’s development of the ARPD—one of the last manual steps in the laboratory testing workflow. The company had recently received CE mark approval in Europe and reported clinical trial results showing a 95% first-stick success rate and strong patient acceptance, positioning the technology as a potential solution to phlebotomy staffing shortages and pre-analytical variability in clinical laboratories.

According to a new press release published on March 10, 2026, this funding round drew strategic backing from several prominent healthcare organizations, including Labcorp Venture Fund, Mayo Clinic, and Sutter Health. Financial investors InterVest, MGFO, PGGM, Puma Venture Capital, and ROM Utrecht also participated, alongside existing investors such as Invest-NL, the EIC Fund, Fred Moll, NYBC Ventures, and Sonder Capital.

For clinical laboratory leaders facing persistent staffing shortages and rising specimen volumes, the investment highlights growing industry interest in automating one of healthcare’s most common clinical procedures.

“Closing our Series B financing reflects strong conviction in our mission to establish a new standard in autonomous robotic venous access and diagnostic blood collection,” said Toon Overbeeke, chief executive officer and co-founder of Vitestro. “Diagnostic blood collection remains the highest-volume invasive medical procedure globally, with billions of procedures performed annually.” (Photo credit: Vitestro)

Automation Targets High-Volume Phlebotomy Workflows

Vitestro plans to use the capital to advance the next generation of its Aletta platform, conduct additional clinical studies, and scale manufacturing as the company prepares for broader commercial rollout in Europe and eventual entry into the United States through the FDA’s de novo regulatory pathway.

The Aletta system combines multimodal imaging, robotics, and artificial intelligence to autonomously identify veins, guide needle insertion, and collect blood samples with high precision. The platform is designed to perform routine diagnostic blood draws, potentially helping laboratories standardize collection quality while reducing human-dependent variability.

For laboratory executives, the technology could offer a new strategy to stabilize phlebotomy operations as workforce shortages persist. By automating routine blood draws, robotic platforms like Aletta may allow organizations to improve workflow predictability, support existing staff, and maintain patient throughput in high-volume outpatient settings.

A forthcoming issue of The Dark Report will feature interviews with Vitestro executives and provide deeper analysis of what autonomous robotic phlebotomy could mean for clinical laboratories, including its potential impact on staffing, workflow efficiency, and specimen quality.

—Janette Wider

Study Hints at Clinical Lab’s Future Role in Investigating Sudden Unexplained Death in Children

UW Medicine and Seattle Children’s launch long-read sequencing research to uncover genetic factors, setting new standards for pediatric genomic testing.

The Sudden Unexplained Death in Childhood (SUDC) Foundation has awarded funding to a team at UW Medicine and Seattle Children’s Hospital to use PacBio HiFi long-read sequencing as a first-line tool to investigate cases of SUDC.

The study represents a critical step in both research and clinical laboratory practice. Applying long-read sequencing as a first-tier assay can streamline workflows, particularly when working with challenging samples such as post-mortem tissue or dried blood spots. Laboratories involved will need to combine advanced sequencing with robust bioinformatics pipelines, accurate variant interpretation, and integration of parental genomes to provide clinically relevant results.

The study, led by Danny E. Miller, MD, PhD, assistant professor of pediatrics and laboratory medicine and pathology at the University of Washington, and Alexandra Keefe, MD, PhD, assistant professor of pediatrics at UW Medicine, will sequence 200 family trios—a child and their parents—aiming to uncover genetic factors that may contribute to these sudden, unexplained deaths.

PacBio’s Revio system with SPRQ-Nx chemistry will be used to generate highly accurate long-read genomes, allowing researchers to detect complex structural variants and tandem repeats that traditional sequencing may miss. By including parental data, the team hopes to distinguish inherited variants from spontaneous mutations, increasing the likelihood of actionable findings for families.

Long-Read Sequencing Advances SUDC Investigations

“Selecting HiFi sequencing as our first-line whole-genome assay allows us to search for answers with the accuracy and breadth these families deserve,” said Miller. “By starting with long reads and incorporating parental data, we can resolve difficult variants, phase them accurately, and provide guidance relevant to SUDC.”

The SUDC Foundation currently assists over 1,000 families in more than 20 countries. The organization emphasizes the importance of comprehensive investigations for sudden child deaths, including genetic testing, DNA banking, and family screening when appropriate.

“Families affected by SUDC face unimaginable loss,” said Julia Burgess, president of the SUDC Foundation. “Funding this project reflects our commitment to advancing research that brings clarity, guidance, and hope to grieving families nationwide.”

Beyond supporting families, the research could establish a model for how cutting-edge genomic testing is incorporated into clinical investigations of sudden childhood deaths. The team plans to implement a tiered genomic approach for cases with suspected genetic causes, beginning with trio-based exome and low-pass whole-genome sequencing, followed by reflexive long-read sequencing when necessary.

“This project has the potential not only to provide answers to families but also to transform standards for genetic investigation in pediatric sudden death,” said Keefe. “It highlights the essential role laboratories play in turning advanced genomic technologies into actionable clinical knowledge.” (Photo credit: UW Medicine)

The SUDC Foundation expects the study, funded at $328,133 over four years, to generate data that supports broader adoption of long-read sequencing in pediatric genomics and enhance understanding of the genetic underpinnings of SUDC.

For clinical laboratory professionals, this initiative underscores the growing expectation that advanced genomic technologies—particularly long-read whole-genome sequencing and trio analysis—will play a larger role in investigating unexplained pediatric deaths. As these tools move toward first-line use, labs must be prepared to support complex variant detection, robust bioinformatics interpretation, and collaboration with clinicians and medical examiners, positioning the laboratory at the center of efforts to deliver clearer answers for families.

—Janette Wider

National Safety Council Launches SIF Prevention Tool that Clinical Laboratories Can Use

New digital assessment helps lab leaders identify systemic safety gaps before serious injuries and fatalities occur.

Dark Daily’s sister publication, Lab Manager, recently reported that the National Safety Council (NSC) has launched a new digital assessment tool designed to help laboratories identify systemic safety weaknesses before they lead to serious injuries and fatalities—high-consequence events that can carry significant human and financial costs.

Called the Organization Safety Gap Analysis Tool, the platform adapts NSC’s evidence-based SIF Prevention Model into an interactive, structured evaluation tailored to complex work environments such as clinical laboratories. The initiative was developed through NSC’s Work to Zero program in partnership with the NCCCO Foundation.

For clinical laboratories that already operate on tight staffing models, the NSC tool may help identify areas for investment that will keep workers safer.

Moving Beyond Compliance to Prevent High-Severity Laboratory Incidents

Serious injuries and fatalities (SIFs) are rare but catastrophic events that result in life-altering harm or death. In laboratory settings, they can arise from chemical exposures, fires, equipment malfunctions, uncontrolled energy releases, or containment failures. Unlike minor injuries, SIFs typically emerge from organizational and system-level breakdowns rather than a single unsafe act—making them difficult to detect through conventional safety audits.

Traditional compliance reviews often focus on lagging indicators such as recordable injury rates and incident counts. While those metrics remain important, they do not necessarily reveal whether safety systems are strong enough to prevent high-severity events. The new SIF prevention tool shifts the emphasis from counting past incidents to evaluating whether leadership practices, hazard identification processes, and control systems are capable of preventing catastrophic outcomes.

Photo credit: “Medical Laboratory” by ben.dracup is licensed under CC BY 2.0.

The digital assessment can be completed in approximately 10 to 15 minutes. Laboratory leaders respond to a series of statements using a color-coded scoring system—green for full compliance, yellow for partial compliance, and red for limited or no evidence of compliance. The platform then generates a customized summary highlighting strengths, identifying safety gaps, and offering targeted recommendations aligned with best practices.

The tool evaluates performance across seven core elements that NSC identifies as critical to preventing serious injuries and fatalities: the safety and health operating environment; management leadership; worker engagement; hazard identification and prioritization; hazard abatement and control; implementation and operation; and continuous improvement.

High-Severity Risk is a Business Risk

Together, these elements are designed to uncover systemic vulnerabilities that may not surface during routine inspections or regulatory compliance reviews.

For laboratories, the business implications extend well beyond worker safety. Clinical labs routinely handle volatile chemicals, compressed gases, biological agents, cryogenic systems, and high-energy equipment. While most facilities meet baseline regulatory requirements, catastrophic incidents often occur when multiple small failures align—failures that may go unnoticed without a structured, system-level evaluation.

A single serious event can result in operational shutdowns, regulatory scrutiny, liability exposure, reputational damage, and increased insurance costs. As accrediting bodies and regulators place greater emphasis on high-severity risk prevention, laboratory leaders are under increasing pressure to demonstrate that their safety programs are proactive, data-driven, and capable of controlling enterprise-level risk.

By benchmarking safety maturity and pinpointing gaps in leadership alignment, hazard prioritization, and control effectiveness, the SIF prevention tool offers laboratory managers a framework for more strategic decision-making. Results can inform investments in engineering controls, workforce training, operational safeguards, and internal audit processes.

As laboratory environments grow more complex and regulatory expectations continue to evolve, industry observers note that organizations can no longer rely solely on compliance-based approaches. Systematic prevention of high-consequence events is becoming a core component of sustainable laboratory operations—and a critical safeguard for both people and business continuity.

—Janette Wider

;