News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

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CDC Testing Pause Puts Clinical Labs at the Center of Public Health Response

With CDC testing paused, clinical labs are stepping up to sustain surveillance and protect timely disease detection.

A temporary pause in infectious disease testing at the Centers for Disease Control and Prevention (CDC) is raising concerns among public health experts, even as officials emphasize the move is part of routine quality assurance efforts.

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.

CDC Testing Pause Raises Surveillance Concerns, Despite Routine Review Efforts

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.

Despite broader instability in public health infrastructure, Scott Becker, MS, CEO of the Association of Public Health Laboratories (APHL), said the pause is not tied to those challenges. Instead, he described it to CIDRAP News as part of an ongoing effort to evaluate testing quality that began in 2024.

“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)

Still, some public health leaders are uneasy about the broader implications. Sarah Henn, MD, MPH, chief health officer at Whitman-Walker Health, emphasized to CIDRAP News the importance of federal coordination in disease response.

“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.

Federal officials say some paused tests will return in the coming weeks. “In the meantime, CDC stands ready to support our state and local partners to access the public health testing they need,” said Emily G. Hilliard, press secretary for the Department of Health and Human Services.

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.

—Janette Wider

Most Women Still Prefer In-Clinic Cervical Cancer Screening, Study Finds

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.

—Janette Wider

Survey: Patients Push for Predictive Lab Testing as Cost and Reimbursement Pressures Mount

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.

—Janette Wider

Measles Outbreak Grows as US Risks Losing Elimination Status

A growing measles outbreak in South Carolina, combined with rising cases nationwide, is putting renewed pressure on clinical and public health laboratories as the US risks losing its measles elimination status.

A rapidly expanding measles outbreak in South Carolina is reinforcing the critical role laboratories play in outbreak detection and response. State health officials report 188 measles cases statewide, with 185 linked to a concentrated outbreak in the Upstate region.

The outbreak is centered around elementary schools with low vaccination rates, a setting that often drives sudden spikes in testing demand. For laboratory leaders, these environments can translate into urgent diagnostic needs and close coordination with public health officials.

Health authorities say most new cases are tied to known exposures. Four recent infections were linked to household transmission, and one resulted from a previously reported school exposure.

However, signs of broader spread are emerging. The source of three new cases remains unknown, and another is still under investigation, suggesting transmission may be extending beyond clearly identified clusters.

As of the week of Dec. 29, 2025, 223 individuals in South Carolina were under quarantine following measles exposure. Each quarantine case increases reliance on timely laboratory confirmation to support isolation, contact tracing, and clearance decisions.

Photo credit: CDC

Vaccination status among patients is low and a likely contributor. Of the 185 cases in the Upstate cluster, 172 individuals were unvaccinated. Four had unknown vaccination status, and only one patient was fully vaccinated.

Children make up the vast majority of infections. Forty patients are under age five, while 123 are between ages five and 17, reinforcing the role of school-based transmission and pediatric testing demand.

Regional Spread Raises Stakes

South Carolina’s surge mirrors similar outbreaks in the western United States. Arizona has now reported 205 measles cases, while neighboring Utah is tracking 156.

Many of those infections are linked to a multistate outbreak centered in Mohave County, Arizona, and Southwest Utah. The pattern highlights how quickly localized outbreaks can expand across jurisdictions.

Nationally, the situation is becoming more serious. By the end of December, the United States surpassed 2,000 measles cases.

At that level, the country risks losing its measles elimination status, first achieved in 2000. Losing the designation would signal the return of sustained endemic transmission and likely intensify surveillance and reporting requirements.

For laboratory leaders, these developments may bring increased volumes of measles PCR and serology testing, particularly in pediatric and outpatient settings. Rapid turnaround times will remain essential for guiding quarantine and infection control decisions.

Public health laboratories may also face expanded workloads related to confirmatory testing and molecular tracking of transmission chains. As measles resurges, laboratories once again serve as a frontline defense—where preparedness, capacity planning, and coordination can directly shape outbreak control.

—Janette Wider

Temporary Delay in PAMA Reductions Provides Labs More Time to Plan

The Senate’s government funding proposal includes a 30-day delay in PAMA cuts, giving clinical labs more time to prepare for reduced Medicare reimbursement rates.

Tucked into the Senate’s government funding proposal is a modest yet impactful measure that gives clinical laboratories a brief reprieve from PAMA reimbursement cuts.

On Nov. 10, the Senate amended and passed a version of a House funding bill, H.R. 5371, designed to reopen the government and allocate funding across multiple agencies. Among its 394 pages is a 30-day stopgap measure delaying PAMA reimbursement cuts, pushing the effective date from January 1 to January 31, 2026.

According to an article from our sibling publication G2 Intelligence, under the Protecting Access to Medicare Act (PAMA) of 2014, laboratories face up to 15% cuts in reimbursement rates for approximately 800 commonly ordered diagnostic tests.

“While this 30-day reprieve provides welcome relief and demonstrates growing awareness of the impact these cuts have on laboratories and patient access, our work is far from done,” said Clarisa Blattner, senior director of revenue and payor optimization at XiFin, who was among the first to publicly note the extension via a LinkedIn post.

Photo credit: “Capitol Hill – Washington, DC” by VinothChandar is licensed under CC BY 2.0.

Technical Revisions Clarify the Phase-in Schedule

The Senate provision references updates to Section 1834A of the Social Security Act, known internally as Section 6209. The amendment modifies how CMS phases in payment reductions based on private payer data:

  • The 2026 calendar year is divided into two periods: January 1–30, 2026, and January 31–December 31, 2026, rather than treating the entire year as a single implementation period.
  • Reporting windows for private-sector payment data, which inform Medicare rates, are also extended. Instead of ending December 31, 2025, the next reporting period will run from February 1 through April 30, 2026.
  • These changes give laboratories additional time to prepare, gather, and validate private payer data while adjusting to new reimbursement rates—a key operational relief, especially for smaller and independent labs.

Extra Time to Advance the RESULTS Act

G2 Intelligence also reported that the temporary delay also offers the clinical lab industry a critical window to rally support for the RESULTS Act (Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act). The bill aims to reform PAMA by reducing reimbursement rate cuts, using an independent database for commercial payer reporting, and lengthening intervals between reporting windows.

Industry observers had warned that Congress was unlikely to again delay PAMA cuts, which have been postponed periodically since the pandemic. The 30-day extension is therefore notable, giving laboratories a short but meaningful buffer to continue advocacy and prepare for upcoming rate adjustments.

Looking Ahead

Laboratory leaders can use this window to assess financial impacts, adjust operational plans, and ensure compliance with updated reporting requirements. As CMS continues to refine its private-payer-based payment system under PAMA, this modest delay offers a critical opportunity to stabilize lab operations and maintain patient access to essential diagnostic services.

—Janette Wider

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