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.
AI-designed molecular sensors could enable ultra-early cancer detection through simple urine tests, signaling major shifts ahead for clinical laboratories and diagnostic workflows.
Artificial intelligence (AI) is beginning to reshape how cancer could be detected and that shift may carry significant implications for clinical laboratories. Researchers at MIT and Microsoft have developed an AI-driven system that designs molecular sensors capable of detecting cancer-linked enzyme activity at extremely early stages, potentially through a simple urine test that could one day be used at home.
The approach centers on proteases, enzymes that are often overactive in cancer and play a role in tumor growth and metastasis. For more than a decade, researchers have explored the idea of using protease activity as a biomarker. Now, AI is accelerating that work by improving the precision and scalability of sensor design.
“We’re focused on ultra-sensitive detection in diseases like the early stages of cancer, when the tumor burden is small, or early on in recurrence after surgery,” said Sangeeta Bhatia, professor of health sciences and technology at MIT and senior author of the study, published in Nature Communications.
From Trial-and-Error Peptides to AI-Optimized Protease Sensors
The researchers coat nanoparticles with short protein sequences, or peptides, that are engineered to be cleaved by specific proteases. When these nanoparticles travel through the body and encounter cancer-associated proteases, the peptides are cut and excreted in urine, where the signal can be detected using a simple paper strip. The pattern of signals could indicate not only the presence of cancer but also its type.
Earlier versions of this technology relied on trial-and-error methods to identify peptides,
often resulting in signals that were not specific to a single protease. While multiplexed peptide panels still produced diagnostic signatures in animal models, they lacked enzyme-level specificity—an important limitation for clinical translation.
The new AI system, called CleaveNet, is designed to overcome that challenge. Using a protein “language model,” CleaveNet can generate peptide sequences optimized for both efficiency and specificity against a target protease.
“If we know that a particular protease is really key to a certain cancer, and we can optimize the sensor to be highly sensitive and specific to that protease, then that gives us a great diagnostic signal,” said Ava Amini, a principal researcher at Microsoft Research. (Photo credit: Microsoft)
For lab leaders, the implications are significant. AI-designed sensors could reduce assay complexity, improve signal clarity, and lower development costs by narrowing the number of biomarkers needed for reliable detection. They also hint at a future where decentralized, at-home testing complements centralized laboratory diagnostics, shifting labs toward validation, data interpretation, and longitudinal disease monitoring.
Bhatia’s lab is now part of an Advanced Research Projects Agency for Health–funded effort to develop an at-home diagnostic capable of detecting up to 30 cancer types in early stages. Beyond diagnostics, the same AI-designed peptides could be incorporated into targeted therapeutics, releasing drugs only within tumor environments.
As AI-driven biomarker discovery advances, clinical laboratories may find themselves at the center of integrating these technologies into regulated testing pathways—reshaping early cancer detection and redefining the lab’s role in precision oncology.
Texas Attorney General Ken Paxton is challenging Epic Systems’ handling of pediatric medical records, alleging unlawful limits on parental access and raising broader questions about data control, compliance, and oversight for providers and laboratories.
For clinical laboratory leaders, the growing legal and regulatory scrutiny of electronic health record (EHR) vendors is no longer a peripheral issue. How patient data are controlled, shared, and accessed has direct implications for test ordering, result reporting, compliance, and patient trust. That context frames a new lawsuit filed by Texas Attorney General Ken Paxton against Epic Systems Corporation, one of the nation’s most dominant health IT companies.
Paxton alleges that Epic has unlawfully monopolized the EHR market and engaged in deceptive practices that restrict parental access to minors’ medical records, in violation of Texas law. Epic’s software houses more than 325 million patient records, representing roughly 90% of the U.S. population, according to the complaint.
Providers and EHRs restrict parental access to adolescent records primarily to comply with state and federal privacy laws. In many states, including Pennsylvania, minors age 13 and older can legally consent to certain types of care—such as mental health services, substance use treatment, sexual and reproductive health, and some infectious disease testing—without parental involvement. When a minor has the right to consent, providers are legally required under state law and HIPAA to keep that related protected health information confidential.
EHR systems like MyChart enforce these rules by automatically limiting parental access when a child turns 13 and masking sensitive results or medications to prevent accidental disclosure. These controls also align with national clinical guidance, including recommendations from the American Academy of Pediatrics, which emphasize protecting adolescent confidentiality to ensure teens seek care and communicate openly with clinicians.
The lawsuit claims Epic uses “exclusionary tactics” to suppress competition, including interfering with hospitals’ ability to use their own patient data and limiting interoperability with competing software. Paxton argues these practices result in incomplete or outdated health records being shared among providers, diminishing care quality for Texas patients and increasing costs for hospitals.
For laboratories, these allegations raise concerns about data liquidity and timely access to diagnostic information. In fragmented or restricted EHR environments, lab results may not follow patients across care settings, potentially affecting clinical decision-making and continuity of care.
Parental Access to Pediatric Records at the Center of Legal Challenge
The suit also focuses on Epic’s handling of pediatric records. Paxton alleges the company automatically restricts parental access to medication lists, treatment notes, and provider messages once a child turns 12. The attorney general argues Epic does not own this data and has no authority to withhold it.
“These deceptive practices undermine the fundamental right of parents to direct their children’s healthcare,” the lawsuit states, citing Texas Health & Safety Code § 183.006, which grants parents “complete and unrestricted access” to their minor children’s medical records.
“We will not allow woke corporations to undermine the sacred rights of parents to protect and oversee their kids’ medical well-being,” Paxton said. “This lawsuit aims to ensure that Texans can readily obtain access to these records and benefit from the lower costs and innovation that come from a truly competitive electronic health records market.”
The Epic lawsuit is part of a broader enforcement push. Earlier this year, Paxton’s office reached a settlement with Austin Diagnostic Clinic requiring full restoration of parental proxy access for patients ages 12 to 17. Civil investigative demands have also been issued to other EHR vendors operating in Texas.
For lab leaders, the case underscores increasing regulatory attention on how diagnostic data are governed inside EHR systems. As states and regulators challenge vendor practices around data access, interoperability, and patient rights, laboratories may find themselves navigating new expectations for transparency, parental access, and compliance—while also reassessing their dependence on a highly consolidated health IT ecosystem.
Mark Cuban argues that fines for healthcare overbilling could drive accountability across the system, putting new pressure on insurers, hospitals, and clinical labs to defend pricing and billing practices.
Imagine your clinical lab got fined every time it overbilled. That’s what Mark Cuban is suggesting. Cuban is once again taking aim at what he calls systemic dysfunction in US healthcare—this time framing billing practices by insurers and providers as a source of both patient harm and missed accountability. For laboratory leaders, the comments land amid growing scrutiny of healthcare pricing, reimbursement transparency, and how frontline diagnostics fit into a system under pressure to justify costs.
In a post on X, Cuban argued that routine overbilling, improper claim denials, and misleading patient cost estimates are so widespread that meaningful enforcement could have enormous fiscal impact.
“If we fined insurers and providers $100 every time they over-billed, incorrectly denied care or misrepresented any amount of patient out of pocket, we could pay off the national debt,” Cuban wrote.
“If we fined insurers and providers $100 every time they over-billed, incorrectly denied care or misrepresented any amount of patient out of pocket, we could pay off the national debt,” Cuban wrote. (Photo credit: Wikipedia.)
Cuban Calls for Reform
He went further, describing a healthcare system he believes is intentionally complex and tilted against patients. According to Cuban, insurers and providers benefit from information asymmetry, leaving consumers overwhelmed by surprise bills, opaque pricing, and shifting out-of-pocket costs.
Cuban called for aggressive structural reform, starting with the insurance industry. He argued that major insurers should be broken up and forced to divest non-insurance businesses, followed by similar action targeting hospitals and pharmaceutical wholesalers. The objective, he said, is to restore competition and make healthcare markets more efficient.
The comments were sparked by a post from Tanner Aliff, founder of Scalpel Policy Solutions, who highlighted recent state laws that allow patients to receive “deductible credit” when they pay cash prices lower than typical insurance reimbursements. These policies let patients save money while still having their spending count toward their annual deductible.
Aliff pointed to high-cost imaging as a clear example. Instead of exhausting a deductible on a $6,000 MRI billed through insurance, patients in certain states can pay roughly $300 in cash for the same service and still receive deductible credit—dramatically reducing their out-of-pocket burden.
So far, only four states—Texas, Indiana, Tennessee, and Oregon—have enacted some version of this reform.
Opposition Voices Doubts
Cuban praised the effort and urged broader adoption, arguing that if cash-pay healthcare spending consistently counted toward deductibles, patients could comparison-shop more effectively. He encouraged people in other states to press lawmakers on why similar policies have not been implemented.
Critics pushed back, questioning whether patients can realistically navigate these options, particularly those managing serious or chronic illness. Financial planner Jae Oh argued that expecting consumers to coordinate cash payments and deductible credits is impractical and potentially harmful.
Cuban countered by pointing to his experience through Cost Plus Drugs, saying he regularly helps patients with deductibles and prior authorizations. While he acknowledged that having cash payments credited toward deductibles remains the hardest part, he insisted that the model already works for many patients.
For laboratory leaders, the debate is a reminder that pricing transparency, billing accuracy, and payer behavior are increasingly under the spotlight. As policymakers and high-profile industry voices push for reforms that empower patients, laboratories may face new expectations around cost clarity, reimbursement practices, and their role in a healthcare system being challenged to prove its value and fairness.
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.
