The association urges stronger regulations and data standards to keep AI safe and fair in clinical laboratories.
The Association for Diagnostics & Laboratory Medicine (ADLM) is calling on Congress and federal regulators to modernize laboratory oversight as artificial intelligence (AI) becomes more embedded in clinical testing, warning that without updated safeguards, AI tools could put patients—particularly those from historically marginalized groups—at risk.
In a recently released position statement, ADLM cautions that while AI has the potential to improve diagnostic accuracy, streamline laboratory workflows, and strengthen data-driven decision-making, poorly governed systems could amplify bias and undermine patient safety. For laboratory professionals evaluating or deploying AI-enabled tools, the message is clear: Oversight, validation, and data integrity must keep pace with innovation.
Bias Risks Drive Push to Update CLIA and Standardize AI Oversight in Clinical Labs
AI models are only as reliable as the data used to train them, the organization noted. When systems are built on limited, inconsistent, or historically skewed datasets, they may replicate societal inequities. In healthcare, that can translate into underestimating disease risk or misclassifying conditions in racial and ethnic minorities, older adults, and underserved populations. Because many AI health tools rely on historical datasets that underrepresent certain groups, laboratories could unknowingly implement algorithms that perform unevenly across patient demographics.
To address those risks, ADLM is urging federal policymakers to explicitly incorporate AI systems into existing laboratory regulations, including updates to the Clinical Laboratory Improvement Amendments (CLIA). The group also recommends that federal health agencies work with professional societies to convene laboratory medicine and informatics experts to establish consensus guidelines for validating and verifying AI tools used in test interpretation and clinical decision support.
As reported on in 2025 by The Dark Report, the call comes in the wake of the federal government’s decision last year to eliminate the Clinical Laboratory Improvement Advisory Committee (CLIAC), a key advisory body to CMS and CDC that could have served as a natural forum for advancing ADLM’s proposed updates to CLIA to address artificial intelligence oversight.
Clinical Labs Push for Data Standards and Clear AI Accountability
In addition, ADLM is calling for expanded federal efforts to harmonize laboratory test results and standardize data reporting. Foundational steps, the organization argues, for reducing variability that can compromise algorithm performance. The statement also presses AI developers to increase data diversity, minimize bias in training datasets, and ensure laboratories have access to the technical information needed to independently evaluate algorithm performance.
“Clinical laboratories are uniquely positioned to help develop and assess the integration of AI health tools into testing workflows and, most importantly, how they influence patient test results and health outcomes,” said ADLM President Paul J. Jannetto, PhD.
Jannetto added, “We therefore urge the federal government to draw on the expertise of laboratory medicine professionals in order to develop AI regulations that support innovation, as well as transparent, consistent performance monitoring of this potentially revolutionary technology.” (Photo credit: ADLM)
For lab executives and medical directors, the position statement reinforces a growing reality: AI governance is quickly becoming a core operational and compliance issue. As adoption accelerates, laboratories may face heightened expectations from regulators, payers, and health system partners to demonstrate that AI-driven tools are analytically sound, clinically validated, and equitable across patient populations.
Despite FDA approval of at-home self-collection kits, 61% of women favor clinician-collected testing, signaling continued stability for traditional lab workflows.
A new national study suggests that while home-based cervical cancer screening is now an option in the United States, most women still prefer in-clinic testing—an important signal for clinical laboratories preparing for potential shifts in specimen volume and workflow.
Researchers at The University of Texas MD Anderson Cancer Center found that 60.8% of screening-eligible women prefer to undergo cervical cancer screening in a clinical setting rather than use an at-home self-collection kit. The findings, published in JAMA Network Open, come months after the Food and Drug Administration (FDA) approved the first home-based self-sampling device for cervical cancer screening, a move intended to expand access and improve uptake among under-screened populations.
Among 2,300 women aged 21 to 65 surveyed through the 2024 Health Information National Trends Survey , 20.4% said they would prefer at-home screening, while 18.8% were unsure. For laboratory professionals, the data suggest that while home-based human papillomavirus (HPV) testing may grow, traditional clinician-collected specimens are likely to remain the dominant source of cervical screening volume—at least in the near term.
For laboratories, the findings suggest that traditional clinician-collected Pap and HPV specimens are likely to remain the primary driver of screening volume in the near term, with home-based kits adding incremental growth rather than immediately shifting overall test mix.
Demographic Differences Point to a More Segmented Screening Market
The study also highlights important demographic differences that could shape outreach strategies and testing patterns. Women who were overdue for screening were more likely to prefer at-home kits, as were individuals who reported experiencing prejudice or discrimination in healthcare settings. Privacy (54.9%), time constraints (35.1%), and avoidance of embarrassment (33.4%) were the most commonly cited reasons for choosing self-collection.
However, Black women were less likely than White women to prefer at-home screening, a finding that underscores the need for culturally tailored education and engagement strategies. Women with lower incomes and those who reported distrust of the healthcare system were more likely to say they were uncertain about which screening option to choose.
For clinical laboratories, these nuances may translate into a more segmented screening market. Health systems and public health programs that deploy mailed self-collection kits could see incremental increases in HPV testing from previously unscreened patients. At the same time, uncertainty and limited familiarity with the newly approved devices—particularly since FDA approval occurred after the survey was conducted—suggest that adoption may be gradual.
“Home-based self-sampling has the potential to remove many of the barriers women face when it comes to cervical cancer screening,” said lead author Sanjay Shete, PhD, of MD Anderson’s Division of Cancer Prevention and Population Sciences. (Photo credit; MD Anderson)
Co-author Joël Fokom Domgue, MD, noted that national organizations such as the Health Resources and Services Administration and the American Cancer Society have already adopted home-based self-collection as part of their screening recommendations, and he suggested broader policy updates could help reduce inequities.
For laboratory professionals, the study underscores both opportunity and operational complexity: Expanding access through self-collection may boost overall screening rates, but in-clinic testing remains the clear preference for most women. Strategic planning around specimen logistics, patient education, and payer policies will likely determine how quickly—and how substantially—home-based screening reshapes the cervical cancer testing landscape.
Genetic tests make up just 5% of volume but now drive 43% of Medicare Part B lab spending, according to OIG’s latest report.
Medicare Part B spending on clinical laboratory testing rose to $8.4 billion in 2024, a 5% increase over the previous year, according to the Department of Health and Human Services’ Office of Inspector General (OIG). For laboratory professionals, the headline is not just rising spending—it’s where the money is flowing.
Although genetic tests accounted for only 5% of all Part B tests performed in 2024, they represented 43% of total lab spending—$3.6 billion. In contrast, the far larger volume of routine chemistry, hematology, and other non-genetic tests generated $4.8 billion. Spending on non-genetic testing has generally declined since 2021, while genetic testing expenditures climbed 20% between 2023 and 2024 alone.
Utilization trends help explain the shift. The number of genetic tests paid under Part B increased 160% between 2018 and 2024, reaching 18 million tests last year. Meanwhile, non-genetic testing volume declined 12% over the same period. More enrollees are receiving at least one genetic test per year, and per-enrollee payments for those services are rising sharply.
Genetic Testing Drives Revenue Growth
In 2024, Medicare paid an average of $794 per enrollee for genetic testing—a 26% jump from 2023. By comparison, per-enrollee spending for non-genetic testing remained relatively stable at just over $200 annually. Even as overall Part B enrollment receiving clinical lab services declined 15% since 2018, spending per genetic-testing patient increased, amplifying the financial impact of molecular diagnostics on lab revenue.
OIG suggests the decline in Part B enrollees receiving lab tests may reflect migration to Medicare Advantage plans. For independent labs heavily dependent on traditional fee-for-service Part B volume, this shift adds another layer of financial pressure and underscores the need to monitor payer mix closely.
High-Dollar Molecular Codes Dominate the Top 25
The concentration of revenue in high-priced molecular assays is intensifying. In 2024, 346 laboratories received more than $1 million in Medicare payments for genetic tests; 55 labs exceeded $10 million. The top 25 laboratory procedure codes accounted for nearly half of all Part B lab spending—more than $4.1 billion.
Genetic tests dominated the fastest-growing segments. CPT code 87798—used for infectious agent detection by nucleic acid when no organism-specific code exists—generated $443 million in 2024, a 51% increase over 2023, making it the highest-paid lab test under Part B. An epilepsy genomic panel (CPT 81419) posted a fivefold spending increase year over year. Several oncology liquid biopsy assays remain among the highest-reimbursed tests, with median payments reaching into the thousands of dollars.
Routine Testing Holds Volume—but Not Spending Power
In contrast, routine tests familiar to every clinical laboratory—comprehensive metabolic panels (80053), CBCs (85025), lipid panels (80061), thyroid testing (84443), and A1C (83036)—either declined or remained flat in spending. Comprehensive metabolic panel spending has dropped 25% since 2018 and fell from the top spending position in 2023 to second place in 2024. These high-volume, low-margin tests continue to anchor daily lab operations but represent a shrinking share of total Medicare dollars.
Importantly, OIG notes that these shifts are not driven by changes in the Clinical Laboratory Fee Schedule, which has remained largely frozen since 2020 under provisions from the Protecting Access to Medicare Act. Instead, spending growth reflects changes in utilization, test mix, and per-enrollee costs.
For clinical laboratory leaders, the message is clear: Medicare’s lab dollars are increasingly concentrated in molecular diagnostics. That shift brings opportunity—but also heightened regulatory scrutiny. OIG’s history of fraud alerts and audits in genetic testing suggests that compliance, documentation, and medical necessity controls will remain critical as high-complexity testing continues to expand within the Medicare population.
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.
