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.
In an economy defined by inflation, burnout, and relentless staffing shortages, compensation has become the clearest fault line in healthcare hiring—and clinical laboratories are caught squarely in it.
LinkedIn survey data shows salary is now the single most influential factor when healthcare professionals consider a job offer, cited by nine out of ten respondents. That includes not just nurses, but “other clinical talent”—a category that spans medical technologists, laboratory scientists, and diagnostic specialists whose work underpins nearly every patient encounter. Practical factors such as schedules, commute distance, and benefits now outweigh softer considerations like culture or leadership, a shift that has sharpened competition across already-strained health systems.
Yet many employers appear to be misreading the room. Just 30% of HR professionals believe salary is the key driver of recruitment, a disconnect that has serious implications for labs already struggling to fill bench roles, night shifts, and specialty testing positions.
Rachel Hawksworth, vice president of talent acquisition at HCA Healthcare was quoted in a report LinkedIn published on the survey. She said, “It’s increasingly important for us to remain competitive by equipping our recruiters with everything they need to talk fluently about our compensation and our benefits.”
Pay Isn’t Enough Anymore—Labs Are Being Forced to Sell Time, Flexibility, and Survival
For lab professionals, whose workloads surged during the pandemic and never fully receded, the stakes are high. When deciding whether to leave a job, 66% of clinical workers cited better pay and benefits as their top motivation. Remote work, scheduling flexibility, and work-life balance followed closely—areas where many clinical labs lag behind nursing and administrative roles.
Recruiters say organizations that can’t match the pay offered by larger systems or national reference labs must sell the total package more aggressively. “It’s hard not to focus on the hourly rate, so it’s important to take the time to explain the value of your overall compensation package,” said Brenda Welch, director of talent acquisition at South Shore Health in the report based on the survey.
But there’s risk in leaning too hard on dollars alone. Higher pay can signal heavier workloads or chronic understaffing—conditions lab professionals know all too well.
“It’s a fine line we have to walk,” said Yvette Hansen of Baylor Scott & White Health in the report. “We also want to be respectful and not signal that we’re trying to ‘buy’ someone.” (Photo credit: Baylor Scott & White Health)
Flexibility has emerged as a rare pressure valve. While bedside nursing has led the way, clinical labs are increasingly being pulled into conversations about alternative schedules, compressed workweeks, and internal mobility. Mercy’s Uber-style shift-selection program boosted staffing by 20% in two years, underscoring how control over time can rival pay itself.
“The value of your time and the value of your health,” Welch said. “That’s what we’re articulating to candidates.”
Behind the scenes, recruitment technology has become another dividing line. Ninety-three percent of highly successful healthcare recruiting teams use an HR information system, and 65% use an applicant tracking system. Less successful teams trail far behind.
Generative AI adoption shows a similar pattern: 45% of top performers use AI-powered recruiting tools, compared with just 23% overall.
“We want more access to tools that give us access to passive candidates because there’s less and less active candidates applying to jobs,” Hansen said—an especially acute problem for specialized lab roles requiring years of training.
Retention, meanwhile, is inseparable from recruitment. Nearly half of clinical workers say salary adjustments are what make them feel supported at work, alongside adequate staffing and manageable workloads. “My mantra is that recruitment is retention,” Welch said. “We can’t think in compartmentalized ways.”
Clinical Labs Can’t Hire Their Way Out of the Talent Crisis
Some systems are betting on internal pipelines to stabilize their workforce. HCA has launched upskilling programs that allow existing employees to move into higher-paying clinical roles. “We’re giving internal talent the opportunity to upskill and advance in their careers,” Hawksworth said—an approach labs see as critical as retirements accelerate.
Education remains a pressure point. While many organizations offer tuition assistance, only 17% provide protected time for learning, despite nearly half of nurses and clinical workers saying time is essential. “There’s evidence to show that mid-career nurses do not feel supported,” said Jennifer Graebe of the American Nurses Credentialing Center, a warning that resonates with mid-career lab professionals weighing exit options.
The message from the labor market is blunt: clinical labs cannot recruit their way out of shortages without confronting pay, workload, and growth head-on. Or as Hawksworth put it, “There’s not one magic lever that will get you the right applicant flow and the right talent to hire.”
For clinical labs already operating in the shadows of the healthcare system, the cost of ignoring that reality may be measured not just in vacancies—but in delayed diagnoses, burned-out staff, and systems stretched past the breaking point.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
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 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.
The Theranos case continues to resonate in the lab community, reminding professionals of the importance of validation, transparency, and accountability.
Elizabeth Holmes, the former CEO of Theranos whose company became synonymous with laboratory fraud, has formally requested an early release from federal prison, renewing attention on one of the most consequential scandals in modern diagnostics.
According to filings with the US Department of Justice’s Office of the Pardon Attorney, Holmes has asked President Donald Trump to commute her sentence, a request that remains under review. If granted, the commutation could shorten her 11-year sentence by nearly six years.
Holmes was convicted in 2022 on multiple counts of wire fraud and conspiracy for misleading investors about Theranos’ blood-testing technology. She began serving her sentence in 2023 at a minimum-security federal prison camp in Bryan, Texas, and is currently scheduled for release on December 30, 2031. Both CNN and ABC News report that a federal appeals court last year upheld Holmes’ conviction, sentence, and a $452 million restitution order that she shares with former Theranos President Ramesh “Sunny” Balwani.
When Hype Outruns the Science
For clinical laboratory professionals, the case remains a stark reminder of the consequences when scientific validation is subordinated to hype.
Theranos claimed it could run hundreds of diagnostic tests using only a few drops of blood—assertions that, if true, would have dramatically reshaped laboratory workflows, patient access, and cost structures. Instead, investigations revealed that the company relied heavily on conventional analyzers while misrepresenting the performance and use of its proprietary technology.
Elizabeth Holmes is currently serving an 11-year sentence at the Federal Prison Camp in Bryan, Texas, for defrauding investors in her company, Theranos; she began her sentence in May 2023 and is eligible for release in December 2031, though she recently asked President Trump to commute her sentence for early release. (Photo credit: Wikimedia Commons.)
The appeals court ruling reinforced a critical principle for the diagnostics industry: financial success, celebrity boards, and political connections do not insulate companies from accountability when analytical validity and transparency are lacking. Judges rejected arguments that legal errors tainted the trial and upheld restitution based on the full amount investors lost, underscoring how severely courts view deception tied to medical testing claims.
As noted by The Dark Report during Holmes’ trial in 2021, testimony provided a series of lessons about how directors of a CLIA-certified labs can be held accountable for violations of federal and state laws.
Why Theranos Still Matters
Holmes’ renewed online visibility has also drawn renewed attention within the laboratory and diagnostics community. According to the CNN article, in recent months, posts have reappeared on her X account, including messages praising Trump’s healthcare affordability efforts and asserting her innocence. While the White House does not comment on pending clemency petitions, the optics of a high-profile fraud case intersecting with presidential pardons, particularly in a second Trump term marked by several controversial commutations, has revived debate about accountability in healthcare innovation.
For laboratories navigating patient expectations, evolving regulatory oversight, and the growth of direct-to-consumer testing, the Theranos case remains a relevant point of reference. The case is frequently cited by regulators and payers as justification for stricter oversight of laboratory-developed tests, more aggressive enforcement actions, and heightened expectations for data integrity.
Regardless of whether Holmes’ sentence is ultimately commuted, her request serves as a reminder that trust in laboratory medicine is hard-won and easily lost. For professionals, the case underscores the importance of scientific rigor, transparent validation, and strong governance in maintaining credibility and trust.
