The research was published in Cell Metabolism and reported by The Scientist, a sibling brand of Dark Daily.
For clinical laboratory professionals, the approach highlights a possible shift away from time-intensive stool-based sequencing toward faster, more scalable testing workflows. “One of the key barriers to integrating our knowledge of the microbiome into clinical care is the time it takes to analyze the data on the microbiome,” said Ariel Hernandez-Leyva, an MD/PhD student working for gut microbiome researcher Andrew Kau’s group at Washington University School of Medicine. (Photo credit: Kau Lab)
Breath-Based Testing Could Streamline Microbiome Workflows
The research team found that volatile organic compounds (VOCs) in breath samples closely correlate with gut microbiome activity, suggesting a streamlined alternative that could reduce turnaround times and expand access to microbiome-informed diagnostics. In both human and mouse studies, breath “volatilome” profiles mirrored microbial metabolites in the gut.
In a proof-of-concept analysis, VOC patterns distinguished children with asthma from healthy controls and predicted levels of a gut bacterial species associated with the condition. Such capabilities could support earlier clinical decision-making and reduce reliance on complex sequencing workflows.
If validated in larger studies, breath-based diagnostics could offer clinical labs a practical pathway to integrate microbiome insights into routine testing, with potential applications in pediatric care, infectious disease risk assessment, and chronic disease management.
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.
The CDC’s Traveler-Based Genomic Surveillance program has surpassed one million voluntary participants, strengthening border-based genomic monitoring that helps clinical, molecular, and public health laboratories detect emerging variants—often days before they appear in community testing, hospital admissions, or public sequence databases.
The CDC announced that its Traveler-Based Genomic Surveillance (TGS) program has surpassed one million voluntary participants, marking a significant expansion of the nation’s upstream pathogen surveillance infrastructure. For clinical, molecular, and public health laboratories, the milestone highlights how border-based genomic monitoring is increasingly being used to identify emerging variants before they appear in community testing or hospital admissions.
Launched in 2021, TGS collects anonymous nasal swabs from arriving international travelers at select U.S. airports and complements this data with aircraft wastewater sampling. Sequencing and analysis are conducted through public-private partnerships with companies such as Ginkgo Biosecurity and XWell, allowing the CDC to generate actionable genomic data even when testing and sequencing capacity may be limited in other parts of the world. The approach reflects a shift toward proactive surveillance models that rely on rapid sequencing and data sharing rather than traditional case-based reporting alone.
Photo credit: CDC
In 2023, Dark Daily reported that San Francisco International Airport became the first US airport to partner with the CDC to test aircraft wastewater for SARS-CoV-2, sending samples to clinical laboratories for PCR testing and genomic sequencing as an early warning system for emerging variants.
Early Genomic Signals Give Laboratories Critical Lead Time on Emerging Variants
CDC officials say the program has already demonstrated practical value for laboratories. In one example, TGS identified new influenza H3N2 subclades and submitted sequences to public databases several days before they were detected elsewhere. For laboratory leaders, early awareness of emerging variants can inform assay validation, test menu planning, reagent procurement, and staffing decisions—particularly during respiratory virus season when demand can shift quickly.
The program also signals a growing role for nontraditional specimen sources in public health surveillance. In addition to traveler samples, CDC has analyzed more than 2,600 aircraft wastewater samples, reinforcing interest in wastewater-based epidemiology as a complementary tool for laboratories and public health agencies seeking earlier signals of emerging threats.
Participation in TGS remains voluntary and anonymous, but its scale suggests increasing acceptance of genomic surveillance as part of routine public health operations. For laboratories, the program offers a preview of how future surveillance systems may operate—integrating high-throughput sequencing, public-private partnerships, and unconventional sampling to deliver earlier warning of pathogens likely to impact diagnostic testing and clinical workflows nationwide.
Researchers report that treatment resistance in advanced prostate cancer is driven by epigenetic lineage plasticity rather than genetic mutations, raising new possibilities for combination therapies and biomarker development in clinical laboratories.
Scientists at the Herbert Irving Comprehensive Cancer Center (HICCC) at Columbia University have identified a molecular mechanism that helps explain why advanced prostate cancers often become resistant to modern hormone-based therapies—and, importantly, how that resistance may be reversed. The findings, published in Nature, describe how prostate tumor cells evade treatment through epigenetic reprogramming rather than genetic mutation, and present preclinical evidence for a drug strategy that could restore treatment sensitivity.
For clinical laboratory professionals, the study highlights the growing relevance of epigenetic regulation, lineage plasticity, and biomarker-driven therapeutic strategies in oncology.
From Hormone Therapy to Lineage Switching
Over the past decade, androgen receptor (AR) inhibitors have become the standard of care for advanced prostate cancer. While initially effective, these therapies frequently drive tumors to adopt a neuroendocrine-like state, a highly aggressive phenotype that no longer depends on androgen signaling and is largely resistant to existing drugs. This transition has posed a longstanding puzzle for cancer biologists and clinicians alike, as it occurs without obvious DNA mutations.
The research builds on decades of work by Michael Shen, PhD, co-leader of the tumor biology and microenvironment program at HICCC, who studies “lineage plasticity”—the ability of cancer cells to change identity under therapeutic pressure. Prior work from Shen’s lab showed that this lineage shift is driven by epigenetic changes rather than permanent genetic alterations, pointing to reversible factors.
To identify the epigenetic drivers, Shen partnered with other Columbia researchers. The team homed in on NSD2, a gene that regulates cellular processes but can also cause cancers during abnormal activity. (Photo credit: Columbia University)
Targeting an “Undruggable” Enzyme to Restore Drug Sensitivity
NSD2 had long been considered “undruggable,” complicating efforts to translate the discovery into a therapeutic strategy. However, recent advances in small-molecule inhibitor development changed that outlook. Using a newly developed NSD2 inhibitor, the researchers demonstrated in prostate cancer models that blocking NSD2 caused neuroendocrine tumors to lose their resistance to therapies.
While NSD2 inhibition alone did not kill tumor cells, its impact was dramatic when combined with other inhibitors. The combination therapy restored sensitivity to standard hormone treatments, effectively resensitizing previously resistant cancers.
For the clinical laboratory community, these findings underscore the importance of epigenetic markers in cancer diagnostics. The ability to distinguish lineage states—and potentially monitor transitions between them—could influence future testing strategies, companion diagnostics, and treatment selection.
More broadly, the study provides one of the clearest demonstrations to date that epigenetically driven treatment resistance can be reversed. Because lineage plasticity is common across multiple tumor types, including small cell lung cancer, the NSD2 pathway may represent a broader therapeutic and diagnostic target.
As these findings move toward clinical testing, laboratories may play a central role in translating epigenetic insights into actionable oncology care.
Federal health officials have updated cervical cancer screening guidelines to add HPV self-collection and require insurer coverage starting in 2027, a shift that could significantly impact testing volumes and workflows for clinical laboratories.
In a move that could significantly reshape testing volumes, workflows, and access strategies for clinical laboratories, the US Health Resources and Services Administration (HRSA) said in a press release that it has issued updated cervical cancer screening guidelines that formally introduce patient self-collection as a new screening option..
Under the updated guidance, high-risk human papillomavirus (hrHPV) testing—using either clinician-collected or patient-collected samples—is now the preferred screening method for average-risk women ages 30 to 65, while Pap testing remains an option. For women ages 21 to 29, Pap testing continues to be recommended.
The guideline also includes a major payer-facing provision that lab leaders should note. HRSA said most insurance plans will be required to cover not only the screening itself, but also any additional testing needed to complete the diagnostic process following an abnormal result. That coverage requirement takes effect January 1, 2027, reducing patient cost barriers that have historically limited follow-up testing volumes.
“These updates represent a significant step forward in cervical cancer screening and will improve screening rates and save lives,” HRSA Administrator Tom Engels said, adding that expanded options and reduced financial barriers allow more women to “take an active role in protecting their health and their future.” (Photo credit: HRSA)
HRSA Update Sets Stage for Insurer-Covered At-Home Testing Starting in 2027
An article from ABC News said the HRSA update aligns federal preventive guidance with recent FDA approvals that now allow both in-clinic and at-home self-collection for HPV testing. The January 2027 deadline for private insurers is expected to accelerate adoption of home-based and alternative specimen collection models.
“The addition of self-collection really empowers women to make this choice for themselves,” Ann Sheehy, MD, HRSA’s chief medical officer, told ABC News. “We do retain the option for Pap smear … this is just an additional choice for women.”
ABC News stated the preferred screening cadence for women ages 30 to 65 is now primary hrHPV testing every five years, whether the sample is collected by a clinician or by the patient. Alternative pathways—co-testing every five years or Pap testing every three years—remain in place if HPV testing is unavailable, preserving flexibility for labs at different stages of HPV test adoption.
HRSA officials emphasized that the goal is expanded access, not replacement of existing workflows. Engels told ABC News that self-collection could help reach women who have “been falling through the cracks,” adding, “By doing that, we’re going to save lives.”
ABC News noted the guidance also clarifies insurer obligations for follow-up diagnostics, including Pap testing, biopsy, and laboratory work, a move designed to prevent cost-sharing from disrupting care pathways. Separate HRSA rules now also require coverage of patient navigation services, which may further increase completed diagnostic testing after abnormal screens.
The American Cancer Society’s (ACS) December 2025 guideline update helped shape the federal move, ABC News said, citing evidence that self-collection improves access without sacrificing accuracy. “The combination of good evidence of the benefits of self-collection, which include increased access to cervical cancer screening, combined with FDA approval, led the ACS and HRSA to include self-collection,” said Robert Smith PhD, senior vice president of early cancer detection science at the ACS.
For lab professionals, HRSA’s announcement underscores a coming shift: broader HPV test demand, increased importance of validated self-collection workflows, and potentially higher follow-up testing volumes as cost barriers fall and screening gaps narrow.
Nearly 90% of patients express interest in predictive lab tests, according to a new national survey—creating new opportunities and challenges for clinical laboratories navigating consumer demand, data fragmentation, and Medicare payment cuts.
A new national survey of 1,000 US patients points to a significant shift in how consumers view diagnostic testing—one that has direct implications for clinical laboratories navigating financial pressure, patient engagement, and changing care models.
The YouGov survey, commissioned by Siemens Healthineers, found that patients increasingly expect greater control over when and why lab tests are ordered. Among adults who have had lab work in the past two years, 93% said they expect their physician to order a test upon request. More than a third (37%) have asked for testing based on information from personal research, such as advice from family, friends, or online sources, and 17% have made requests influenced by social media content. For lab leaders, the data signal a move away from strictly symptom-driven, clinician-initiated testing toward more consumer-driven demand.
Patients Push for Predictive Testing, Testing Provider Authority
Interest in predictive and proactive testing is especially high. Nearly nine in 10 respondents (89%) said they are interested in lab tests that can help predict future health risks. That interest is already translating into action: 27% of patients reported pursuing blood testing from a trusted lab provider out of curiosity, without a physician’s recommendation. Another 22% said they had used at-home or self-tests—such as genetic, fertility, or hormone tests—out of curiosity. While self-testing remains less common than lab-based bloodwork, the trend underscores a growing appetite for earlier insights into health status.
Despite this increased autonomy, trust in clinicians remains strong, though not absolute. While 95% of respondents said they trust their provider to order the most appropriate tests, that confidence drops when a requested test is declined. Thirteen percent said they do not trust their doctor’s guidance if advised against a test they asked for, highlighting a delicate balance for providers and laboratories as patient satisfaction and evidence-based medicine increasingly intersect.
“It’s clear: patients want more control over their health and information about their health earlier,” said Michele Zwickl, head of laboratory solutions for Diagnostics at Siemens Healthineers North America. (Photo credit: Siemens Healthineers)
Data Gaps and Cost Pressures Challenge Labs
The survey also raises concerns about data fragmentation. Nearly half (49%) of patients who pursued testing out of curiosity said they did not share their results with a healthcare provider. Additionally, 20% reported they would not disclose to their doctor if they had followed medical advice from social media. For laboratories, this lack of transparency can complicate result interpretation, particularly when undisclosed supplements, diets, or alternative therapies may influence lab values.
Cost remains a major fault line. While many patients are willing to pay out of pocket for elective or curiosity-driven testing, affordability remains a barrier for essential care. Among respondents with unpaid medical bills, 52% said their debt included unpaid lab testing fees. Still, patients clearly value laboratory diagnostics: 98% said lab results provide meaningful health insights, and 94% reported they are more likely to follow a physician’s advice when it is supported by test results. Notably, patients are far less willing to delay bloodwork due to cost than other services—only 5% would postpone lab tests, compared with 22% who would delay imaging.
These expectations come as laboratories face mounting reimbursement pressure. Upcoming Medicare payment cuts of up to 15% for roughly 800 tests, combined with prior reductions under PAMA affecting 72% of commonly used assays, threaten to widen the gap between patient demand and lab capacity. Industry leaders warn that continued cuts could stifle innovation and limit access. Legislative efforts such as the RESULTS Act are gaining attention as potential mechanisms to stabilize reimbursement and preserve testing access.
For lab leaders, success will hinge on aligning growing patient demand for access and insight with operational and financial sustainability.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
