A long-term study shows increasing rates of therapy-related AML as cancer survival improves, pushing clinical laboratories to expand genomic testing, enhance surveillance, and prepare for more complex secondary malignancies.
A new population-based study published in CANCER, a journal of the American Cancer Society, signals a growing diagnostic and surveillance challenge that clinical laboratories should take note of. Rates of therapy-related acute myeloid leukemia (tAML), a secondary blood cancer linked to prior chemotherapy and radiation exposure, are rising.
Researchers analyzing data from the Osaka Cancer Registry found that tAML incidence increased steadily between 1990 and 2020. Among nearly 10,000 AML cases, 6.5% were therapy-related, with incidence rising from 0.13 to 0.36 per 100,000 people. The proportion of tAML within total AML cases nearly doubled over the study period, reflecting a shifting disease burden tied to improved cancer survival.
“The study provides an important step towards better understanding how the nature of tAML is changing with the increasing number of cancer survivors,” said lead author Kenji Kishimoto, MD, PhD, of the Osaka International Cancer Institute.
For clinical laboratories, the findings underscore the downstream impact of modern oncology treatments. As more patients survive primary cancers, labs are increasingly likely to encounter complex secondary malignancies requiring advanced hematologic testing, molecular profiling, and longitudinal monitoring. tAML, in particular, is associated with prior DNA damage from cytotoxic therapies, often presenting with aggressive clinical features and distinct genetic signatures.
The study also highlights changing patterns in primary cancers preceding tAML. While prior blood cancers remained the most common precursor, cases following breast cancer treatment rose notably over time, suggesting evolving risks tied to treatment regimens and survivorship trends. Colorectal and gastric cancers were also represented, though gastric cancer–associated cases declined.
For lab professionals, this trend reinforces the need to adapt testing strategies, expand genomic capabilities, and collaborate closely with oncology teams as therapy-related malignancies become a more visible component of routine diagnostic workflows.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
The CDC has halted testing for several diseases—including rabies, poxviruses, certain parasites, and lymphocytic choriomeningitis—leaving state and local laboratories to seek alternative testing pathways in the interim. The pause is expected to last at least a few weeks, though some experts predict a longer timeline before full services resume.
Testing conducted by the CDC plays a critical role in national disease surveillance, particularly for smaller or resource-limited public health labs that rely on federal support for complex or uncommon diagnostics. According to an article from CIDRAP News, without that capacity, experts warn, there could be delays in identifying outbreaks or tracking disease spread.
“They’ve been very transparent about this all along,” Becker said, noting that the CDC’s testing portfolio is “enormous” and requires periodic review. (Photo credit: APHL)
“Right now, it is not clear that this level of coordination is in place, and that uncertainty is concerning,” she said.
State and Commercial Labs Step In as Capacity Strains Highlight Need for Systemwide Resilience
In the meantime, larger state and commercial laboratories are stepping in to fill the gap. Facilities such as the Wadsworth Center report they have significant but limited capacity to absorb additional testing demand.
Further, CIDRAP News reported that public health officials are cautioning that even temporary disruptions could impact early disease detection. “A strong public health system has redundancy,” said Ewa King, PhD, chief program officer at APHL, noting that labs are accustomed to sharing resources across jurisdictions.
For clinical laboratory professionals, the CDC’s temporary testing pause is a reminder of the essential role labs play in sustaining a resilient public health system. As demand shifts to state, local, and commercial laboratories, the ability to maintain turnaround times, ensure quality, and coordinate across jurisdictions becomes even more critical. While redundancy within the laboratory network helps absorb short-term disruptions, the situation underscores the importance of continued investment in workforce capacity, infrastructure, and inter-laboratory collaboration, areas that many clinical labs currently struggle with. In an environment where early detection drives effective response, clinical labs remain at the center of protecting population health.
A top public hospital CEO says AI could soon take over radiology functions to cut costs—raising similar automation questions for clinical labs—though critics warn the technology is not ready to replace physicians.
The CEO of NYC Health + Hospitals says his system is prepared to begin replacing radiologists with artificial intelligence (AI) in certain use cases, once regulatory barriers are addressed. From a clinical lab professional perspective, health systems are actively evaluating where AI can reduce reliance on highly trained specialists while maintaining diagnostic throughput.
“We could replace a great deal of radiologists with AI at this moment, if we are ready to do the regulatory challenge,” Katz said.
AI as a Cost and Workflow Strategy
Katz noted that AI could expand access to screening—particularly in breast cancer—while lowering operational costs. One proposed model would shift radiologists into a secondary review role, validating only abnormal findings flagged by AI.
For clinical laboratories, this mirrors ongoing discussions around digital pathology, AI-assisted test interpretation, and automated workflows in areas such as hematology, microbiology, and molecular diagnostics. If imaging adopts a “AI-first, specialist-second” model, similar expectations could follow in the lab.
This approach could deliver what Katz described as “major savings,” particularly for large systems facing staffing shortages and increasing test volumes.
“For women who aren’t considered high risk, if the test comes back negative, it’s wrong only about 3 times out of 10,000,” Lubarsky said, adding that the technology is “actually better than human beings.” (Photo credit: Westchester Medical Center Health Network)
Katz also questioned whether regulations should evolve to allow AI to interpret imaging independently—potentially establishing a precedent that could influence how regulators approach AI in laboratory medicine.
Why Clinical Labs Should Pay Attention
While the discussion centers on radiology, the underlying drivers—cost containment, workforce shortages, and demand for faster turnaround times—are identical pressures facing clinical laboratories.
If regulators permit AI to operate with reduced physician oversight in imaging, labs could see accelerated adoption of AI-driven decision support, automated result interpretation, and even reduced hands-on review in certain testing workflows.
At the same time, the debate highlights a key risk of balancing efficiency gains with diagnostic accuracy and patient safety.
Pushback Raises Safety Concerns
Not all healthcare professionals agree with the direction. Some radiologists warn that current AI tools are not ready for independent clinical use.
“Undeniable proof that confidently uninformed hospital administrators are a danger to patients: easily duped by AI companies that are nowhere near capable of providing patient care,” said Mohammed Suhail, MD, of North Coast Imaging.
“Any attempt to implement AI-only reads would immediately result in patient harm and death, and only someone with zero understanding of radiology would say something so naive.”
The debate signals what may be ahead for the broader diagnostics industry. As health systems test AI-driven models in radiology, clinical laboratories may soon face similar expectations to leverage automation for cost savings—while defending the continued role of expert oversight in ensuring quality and patient safety.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
New research shows a single toxic exposure during pregnancy may drive disease risk across generations, highlighting emerging opportunities for clinical labs to leverage epigenetic biomarkers for earlier, preventative diagnostics.
A new study from Washington State University suggests that a single exposure to a toxic fungicide during pregnancy may influence disease risk for up to 20 generations, with implications for how clinical laboratories understand chronic disease and prevention strategies.
Epigenetic Inheritance Expands the Diagnostic Timeline
The study found that exposure to vinclozolin—a fungicide commonly used in agriculture—triggered disease patterns in rats that persisted for 20 generations. Notably, disease incidence not only continued but worsened in later generations, with severe reproductive complications emerging.
“This study really does say that this is not going to go away,” Skinner said. “We need to do something about it. We can use epigenetics to move us away from reactionary medicine and toward preventative medicine.” (Photo credit: Washington State University)
For clinical laboratories, these findings show a growing shift toward understanding disease not just as an immediate or genetic condition, but as one influenced by ancestral environmental exposures.
Germline Changes Drive Long-Term Risk
Unlike traditional toxicology models, the study highlights how disease risk is transmitted through epigenetic changes in germline cells—sperm and eggs—rather than direct exposure alone.
“Essentially, when a gestating female is exposed, the fetus is exposed,” Skinner explained. “And then the germline inside the fetus is also exposed… Once it’s programmed in the germline, it’s as stable as a genetic mutation.”
This mechanism suggests that clinical labs may need to consider multi-generational risk factors when interpreting biomarkers or assessing patient risk profiles.
Disease Burden Intensifies Over Generations
While disease prevalence remained relatively stable across early generations, researchers observed a sharp increase in severity beginning around the 15th generation.
“By the 16th, 17th, 18th generations, disease became very prominent and we started to see abnormalities during the birth process,” Skinner noted. “Either the mother would die, or all the pups would die, so it was a really lethal sort of pathology.”
These findings suggest that long-term population health trends—such as rising chronic disease rates—may have roots in historical environmental exposures.
Implications for Clinical Laboratories
The research aligns with broader epidemiological trends showing increased rates of chronic diseases, including cancer and cardiovascular conditions. According to the CDC, more than three-quarters of Americans now live with at least one chronic disease.
For laboratories, the study underscores the potential value of epigenetic biomarkers in predicting disease susceptibility well before clinical symptoms appear.
Moving Toward Preventative Diagnostics
As clinical laboratories continue to expand their role in precision medicine, epigenetic testing may offer a pathway to earlier intervention and improved patient outcomes.
By identifying individuals at elevated risk decades in advance, labs could support a shift toward preventative care models—helping clinicians intervene before disease onset rather than reacting after diagnosis.
For lab leaders and pathologists, the study highlights that diagnostics may soon extend beyond the individual patient to include inherited environmental risk factors spanning generations.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Walk-in lab testing in West Virginia is giving patients faster, more affordable access to diagnostics—while pushing clinical labs to adapt to a more consumer-driven care model.
Across the clinical laboratory industry, the shift toward consumer-directed healthcare continues to gain momentum. A recent report by the Charleston Gazette-Mail highlights a growing trend in West Virginia of walk-in laboratory services that allow patients to bypass traditional physician referrals for routine diagnostic testing.
For pathologists and clinical lab professionals, this shift represents a significant evolution in the traditional diagnostic workflow. Facilities like Any Lab Test Now and local hospital-affiliated outreach centers are increasingly offering direct-to-consumer (DTC) options, allowing individuals to purchase tests such as lipid panels, glucose levels, DNA, and toxicology screens.
Key Drivers of Walk-In Testing
The article identifies several factors pushing patients toward walk-in labs:
Cost transparency: Many patients with high-deductible health plans are choosing walk-in labs that offer transparent, upfront pricing, often avoiding the “sticker shock” of traditional hospital billing.
Convenience and speed: The ability to walk in without an appointment and receive results via secure online portals—often within 24 to 48 hours—appeals to the modern healthcare consumer.
Proactive health management: There is a growing demographic of proactive patients who wish to monitor chronic conditions or wellness markers more frequently than their annual, insurance-covered physical allows.
“This gives [patients] an opportunity to manage their own health,” said Matt Brooks, director of clinical laboratory services at Marshall Health Network based in Huntington, W.V. “And it gives patients the opportunity to pay for the test without having to go through their insurance.” (Photo credit: Marshall Health Network).
The Changing Role of the Provider
While the convenience is clear, the trend raises questions regarding the interpretation of results. Patients have access to more data, yet they still require professional guidance to put that data into clinical context.
Most walk-in models encourage patients to share their results with their primary care physicians, but the “patient-as-the-customer” model places the initial responsibility for action squarely on the individual.
Implications for Clinical Labs
For traditional clinical laboratories, the growth of walk-in testing in regions like West Virginia serves as a signal to adapt. As patients become more accustomed to retail-style healthcare experiences, laboratories may need to invest more heavily in user-friendly digital interfaces and transparent pricing structures to remain competitive.
This trend also underscores a broader national movement. As more states relax regulations regarding DTC testing, the laboratory’s role is shifting from a behind-the-scenes diagnostic provider to a front-facing participant in the patient’s healthcare.
