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.
Promising retrospective results raise long-term possibilities for labs, even as clinical and regulatory plans remain unclear.
NIH-supported researchers have identified a new four-marker blood test that may improve the early detection of pancreatic ductal adenocarcinoma (PDAC), one of the deadliest and most difficult cancers to diagnose at a treatable stage. The findings, published in Clinical Cancer Research, could have long-term implications for clinical laboratories if the approach is validated in future studies, though significant hurdles remain before it could reach routine clinical use.
Pancreatic cancer has a notoriously poor prognosis, largely because it is often diagnosed after the disease has already advanced. According to the researchers, “only about 1 in 10 pancreatic cancer patients survive more than five years from diagnosis.” By contrast, survival improves substantially when tumors are detected early. However, as the authors note, “there are no current screening methods” capable of reliably identifying pancreatic cancer before symptoms appear.
Why Existing Markers Fall Short
In the study, investigators from the University of Pennsylvania’s Perelman School of Medicine and the Mayo Clinic used a phased, retrospective approach to evaluate blood-based biomarkers using banked samples. Two previously studied markers—carbohydrate antigen 19-9 (CA19-9) and thrombospondin 2 (THBS2)—were included because of their historical relevance in pancreatic cancer research. CA19-9, for example, is commonly used in clinical settings to monitor treatment response.
However, neither marker has proven suitable for population screening. CA19-9 “can be elevated in people with benign conditions such as pancreatitis and bile duct obstruction,” and some individuals “don’t produce it at all due to genetic factors,” limiting its clinical specificity and sensitivity. These limitations are well known to laboratory professionals who routinely interpret CA19-9 results in oncology workflows.
The researchers identified two additional proteins—aminopeptidase N (ANPEP) and polymeric immunoglobulin receptor (PIGR)—that were elevated in early-stage pancreatic cancer patients compared with healthy controls. When combined with CA19-9 and THBS2, the resulting four-marker panel demonstrated improved performance.
For all cancer stages combined, the panel distinguished pancreatic cancer cases from non-cases 91.9% of the time at a false positive rate of 5%. For early-stage disease (stage I and II), the test identified 87.5% of cases.
“By adding ANPEP and PIGR to the existing markers, we’ve significantly improved our ability to detect this cancer when it’s most treatable,” said lead investigator Kenneth Zaret, PhD. (Photo credit: Perelman School of Medicine at the University of Pennsylvania)
Encouraging Performance, Early Days
Importantly for clinical laboratories, the test was able to differentiate cancer patients not only from healthy individuals, but also from patients with non-malignant pancreatic conditions, including pancreatitis—an area where many candidate biomarkers have historically struggled.
Despite the promising results, the authors stress that the findings are preliminary. “Our retrospective study findings warrant further testing in larger populations, particularly in people before they show symptoms,” Zaret said. He added that so-called “prediagnostic” studies would be required to determine whether the assay could be used as a screening tool in high-risk populations, such as individuals with a family history of pancreatic cancer or known genetic risk factors.
Notably, neither the NIH announcement nor the published coverage includes any public information about plans for FDA submission, commercialization, or clinical deployment of the test. There is no mention of whether the assay would be developed as a laboratory developed test (LDT), licensed to a diagnostics company, or pursued through a formal regulatory pathway.
For now, the four-marker panel represents a research advance rather than a near-term clinical offering. Still, it highlights how multi-analyte blood tests may eventually reshape cancer screening—and presents an area for clinical laboratories to watch closely as validation studies progress.
A new KFF Health Tracking Poll shows healthcare costs are now the top economic worry for U.S. households—raising concerns that patients may skip screenings or shop more aggressively for lab tests, reshaping utilization and revenue patterns in 2026.
Healthcare costs are now the top economic concern for US households—and that anxiety is likely to ripple directly into clinical laboratories, according to a new KFF Health Tracking Poll released January 29.
Roughly one-third of the public (32%) say they are “very worried” about their ability to afford healthcare, a higher share than those most concerned about food, housing, utilities, or transportation. More broadly, 56% expect healthcare to become less affordable for their families in the coming year, signaling sustained pressure on patients’ willingness and ability to engage with the health system.
For clinical laboratories, that concern translates into two distinct, and potentially competing, patient behaviors.
Rising Costs Could Reshape Patient Testing Behavior
In one scenario, patients worried about out-of-pocket costs may delay or skip preventive screenings and fail to follow through on physician-ordered diagnostic testing. KFF found that about one in five respondents said their healthcare costs have risen faster than basic necessities like utilities or groceries. That perception alone can be enough to discourage patients from completing tests they view as optional, even when those tests are clinically indicated.
In another scenario, cost-conscious patients may still pursue testing but do so more selectively. Rather than abandoning care altogether, these patients may “shop around,” comparing prices, turnaround times, and service offerings across clinical laboratories. This trend could increase demand for clearer test pricing, stronger patient-facing communication, and more transparent billing practices—areas where some labs may find both challenges and opportunities.
The poll also suggests that cost concerns are not confined to any single demographic or political group. Healthcare costs ranked as the top economic worry among Democrats, independents, and Republicans alike. More than four in ten voters (44%) say healthcare costs will have a “major impact” on whether they vote in the upcoming midterm elections, underscoring how personally felt the issue has become.
Policy Shifts Add New Pressure to Coverage and Affordability
Recent policy changes may be amplifying these anxieties. Congress allowed enhanced Affordable Care Act (ACA) tax credits to expire, a move that two-thirds of the public (67%) say was “the wrong thing” to do. The expiration is expected to increase premium payments for many marketplace enrollees, potentially leaving patients with less discretionary income for lab testing and other medical services.
While most Americans still view the ACA favorably—58% overall—that support has softened since last fall, reflecting ongoing uncertainty about coverage stability and affordability. For labs, fluctuations in insurance coverage can complicate reimbursement, increase patient self-pay balances, and add friction to pre-test counseling and billing workflows.
Taken together, the findings point to a year in which clinical laboratories may see uneven test utilization patterns. Some patients may disappear from the testing pipeline altogether, while others arrive armed with questions about cost, necessity, and alternatives.
As financial anxiety increasingly shapes patient decision-making, labs that can clearly communicate value—clinical relevance, quality, speed, and cost transparency—may be better positioned to maintain trust and test volume in an environment where affordability is front of mind.
Researchers note that many sources of errors associated with diagnostic testing involve how providers order tests and how specimens are handled
ECRI (Emergency Care Research Institute), a non-profit organization that focuses on healthcare quality and patient safety, has released results from a study which lays blame for most diagnostic errors on systemic issues that arise during clinical laboratory, radiology, and other diagnostic testing processes. These issues relate to “ordering, collecting, processing, obtaining results, or communicating results,” the organization stated in a news release.
“It’s a common misconception that if a patient has a missed or incorrect diagnosis, their doctor came up with the wrong hypothesis after having all the facts,” said ECRI President and CEO Marcus Schabacker MD, PhD, in the news release. “That does happen occasionally, but we found that was tied to less than 3% of diagnostic errors. What’s more likely to break the diagnostic process are technical, administrative, and communication-related issues. These represent system failures, where many small mistakes lead to one big mistake.”
The researchers based their analysis on reports of adverse patient safety events and “near-misses” submitted to ECRI and the Institute for Safe Medication Practices (ISMP) in 2023. Healthcare providers submitted the data from across the US, ECRI noted.
From a total of 3,014 patient safety events, ECRI determined that 1,011 were related to diagnostic errors. Then, it sorted the events based on “the appropriate step in the diagnostic process where the breakdown occurred,” according to the news release.
ECRI did not reveal how many errors were related to clinical laboratory testing as opposed to radiological or ultrasound imaging.
“The problem of diagnostic safety comes down to the lack of a systems-based approach,” said ECRI President and CEO Marcus Schabacker MD, PhD (above), in a news release. “Since there are multiple potential failure points, a single intervention is insufficient.” Diagnostic errors can also include imaging/radiology and other types of diagnostic procedures—not just clinical laboratory tests. (Photo copyright: ECRI.)
Where Errors Occur
According to ECRI’s analysis, the largest number of errors by far (nearly 70%) happened during the clinical laboratory testing process. Among these, “more than 23% were a result of a technical or processing error, like the misuse of testing equipment, a poorly processed specimen, or a clinician lacking the proper skill to conduct the test,” ECRI stated. “Another 20% of testing errors were a result of mixed-up samples, mislabeled specimens, and tests performed on the wrong patient.”
Outside the testing process, other errors occurred during monitoring and follow-up (12%) and during referral and consultation (9%).
One major factor behind diagnostic errors, ECRI noted, was miscommunication among providers and between providers and patients.
The organization also cited “productivity pressures that prevent providers from exploring all investigative options or from consulting other providers” as leading to diagnostic errors.
In some cases, providers who ordered lab tests delayed reviewing the results or the patients were not notified of the results.
“Referrals to specialists or requests for additional consultations can complicate the process, presenting more potential failure points,” ECRI noted.
Troubling Imaging Anecdotes, Previous Studies
The ECRI news release cites two de-identified patient stories, both related to imaging. One case involved a woman who “experienced abdominal pain and abnormal vaginal bleeding,” but a diagnosis of uterine cancer was delayed nearly a year. “MRIs were ordered, but not all the results were reviewed, as her symptoms worsened. Despite masses being detected on an ultrasound, a missed appointment and communication barriers delayed her diagnosis. She was finally diagnosed after severe pain led to hospitalization.”
In one “near-miss” incident, a patient did not receive an essential carotid ultrasound procedure prior to being scheduled for open-heart surgery. Staff caught the omission and canceled the surgery. A later ultrasound “revealed he would have had a catastrophic surgical outcome if the surgery had proceeded as scheduled,” ECRI stated.
Two earlier studies noted in the news release highlight the impact of diagnostic errors.
A 2017 study, published in the journal BMJ Quality Safety, estimated that diagnostic errors affect approximately 5% of US adults—a total of 12 million—each year. In that paper, the authors combined estimates from three observational studies that defined diagnostic error in similar ways.
“Based upon previous work, we estimate that about half of these errors could potentially be harmful,” the authors wrote.
And a 2024 study published in the same journal estimated that 795,000 Americans die or become permanently disabled each year due to misdiagnosis of dangerous diseases. “Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined,” the authors wrote.
Recommendations for Providers, Labs
ECRI advised that healthcare providers should adopt a “total systems safety approach and human-factors engineering” to reduce diagnostic errors. This is good advice for clinical laboratories as well.
Specific steps should include “integrating EHR workflows, optimizing testing processes, tracking results, and establishing multidisciplinary diagnostic management teams to analyze safety events,” the news release states.
Schabacker also advised patients to “ask questions to understand why their doctor is ordering tests, and are those tests urgent,” he said. “Schedule your appointments and tests quickly and follow up with your provider if you’re awaiting results. If possible, ask a family member or friend to join you in important appointments, to help ask questions and take notes.”
Clinical laboratory managers have been alerted to the involvement of lab testing in incidents of medical errors. This report by ECRI is more evidence of the gaps in care delivery that often contribute to medical error. Medical lab professionals may want to review the ECRI report to learn more about what the authors identify as the specific breakdowns in care processes that contribute to medical errors.
After seeing a rise in the volume of clinical lab tests physicians order, managed care plans are develop a variety of strategies to manage utilization and costs
Health insurers are taking more aggressive actions to control the cost of clinical laboratory testing. For many years, clinical laboratories and pathology groups have been concerned about the strategies used by Medicare to control the utilization and costs of medical laboratory tests. Private health insurers usually follow the actions of Medicare, the nation’s largest health insurer. But today, managed care plans are developing their own lab-test-utilization strategies in addition to following those of Medicare.
