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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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

AI-Designed Cancer Sensors Could Transform Early Detection—and What It Means for Clinical Labs

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.

—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

Testmate Health and Intermountain Health Partner to Expand Rapid STI Testing Access

A new partnership between Intermountain Health and Testmate Health aims to bring rapid, lab-quality STI testing out of the central lab and into underserved communities, addressing persistent gaps in diagnosis and follow-up care.

Testmate Health and Intermountain Health have entered a strategic partnership and investment aimed at accelerating access to rapid, low-cost molecular testing for sexually transmitted infections (STIs) across the US.

For clinical laboratory leaders, the collaboration signals a growing push to move high-quality molecular diagnostics closer to patients, particularly those belonging to underserved and high-risk populations.

STIs continue to represent a major public health challenge, with an estimated 80% of chlamydia and gonorrhea infections going undiagnosed each year. Delays in testing and treatment are especially common among college students, LGBTQ+ populations, and patients served by rural or resource-limited clinics. The two organizations say their partnership is designed to close those gaps by making accurate, lab-quality testing available outside of traditional laboratory environments.

Bringing Molecular Diagnostics Beyond the Central Lab

Under the agreement, Intermountain Health will support the deployment of Testmate’s single-use, reader-free molecular tests for Chlamydia trachomatis and Neisseria gonorrhoeae. The tests are designed to deliver results in under 30 minutes and do not require central lab infrastructure. They can be used with urine or swab samples, offering flexibility for a range of care settings.

Karen Brownell, vice president of Lab Services at Intermountain Health said, “When these STI tests become FDA-approved in the US, Testmate’s innovative approach to molecular diagnostics will allow us to deliver lab-quality results outside traditional lab settings, directly impacting communities that have historically lacked access to timely testing.” (Photo credit: ContactOut)

Addressing Access, Turnaround Time, and Follow-Up

Testmate’s leadership emphasized that reducing barriers to testing is central to improving outcomes. Rapid turnaround times may help clinicians initiate treatment during the same visit, reducing loss to follow-up—a persistent issue in STI management.

The organizations say combining Testmate’s physician-developed diagnostics with Intermountain’s clinical infrastructure could also lower overall healthcare costs by enabling earlier detection and treatment.

For laboratory leaders, the collaboration highlights a broader trend toward decentralized molecular testing and point-of-care strategies that complement, rather than replace, core laboratory services. As health systems look to improve access and equity while managing costs, partnerships like this one may foreshadow how labs extend their impact beyond traditional walls.

—Janette Wider

CAP Issues New Evidence-Based Guideline to Improve Amyloidosis Diagnosis

The College of American Pathologists outlines standardized testing and typing methods aimed at reducing diagnostic variability and improving outcomes for patients with this rare but serious disease.

Clinical laboratory leaders facing growing demand for precision diagnostics now have new guidance to support one of pathology’s most complex diagnostic challenges. The College of American Pathologists (CAP) has published an evidence-based guideline designed to standardize laboratory approaches to diagnosing amyloidosis, a rare but life-threatening condition that often goes undetected until advanced stages.

Amyloidosis occurs when abnormal amyloid proteins accumulate in tissues and organs, leading to progressive damage. Because symptoms can mimic other diseases and diagnostic techniques vary widely between laboratories, delays and misclassification have long been a concern. CAP’s new guideline aims to reduce that variability by defining best practices for amyloid detection, fibril protein typing, and specimen evaluation.

The recommendations were developed by a multidisciplinary expert panel that reviewed more than 4,000 peer-reviewed studies. The result is a practical framework intended to help pathologists select the most accurate testing strategies while improving consistency across laboratories.

“This guideline is meant to improve the consistency and accuracy of laboratory diagnoses for systemic amyloidosis,” said Dylan V. Miller, MD, FCAP, guideline co-chair.

Dylan V. Miller, MD, FCAP, guideline co-chair noted, “Clearer standards will support more reliable diagnoses and ultimately better outcomes for patients.” (Photo credit: American Board of Pathology)

Best Practices for Amyloid Detection and Typing

Among the recommendations, the guideline reinforces Congo red staining as the diagnostic standard for detecting amyloid, while noting that fluorescence microscopy may enhance sensitivity in laboratories where it is available. Cytology, including fat pad aspirates, may be appropriate for initial screening due to its minimally invasive nature, but the guideline cautions that such samples are often insufficient for definitive subtyping.

For amyloid protein identification, the panel recommends mass spectrometry as the most accurate and sensitive method, particularly in complex or ambiguous cases. CAP emphasizes that precise protein typing is essential, as treatment options and prognoses vary significantly depending on amyloid subtype.

“Amyloid science is advancing rapidly, with new imaging, typing, and therapies reshaping the field,” said Billie Fyfe-Kirschner, MD, FCAP, guideline co-chair. “For pathologists, staying current is essential to ensure accurate diagnoses and guide patient care.”

Rising Need for Advanced Diagnostics and Long-Term Planning

From a management perspective, the guideline underscores the growing importance of advanced diagnostic capabilities, including access to validated staining methods and mass spectrometry. For lab leaders, this may influence decisions around test menus, referral relationships, and investment in specialized technologies.

CAP plans to reassess the guideline at least every five years, or sooner if major scientific or clinical advances occur. As amyloidosis awareness increases and targeted therapies expand, laboratory accuracy will play an increasingly central role in patient outcomes.

For clinical laboratory leaders and pathologists, the new guideline provides a roadmap for improving diagnostic confidence, standardizing workflows, and aligning laboratory practices with evolving expectations for precision medicine.

—Janette Wider

Georgia Students Build CRISPR Lyme Test That Detects Infection in 48 Hours

Teen researchers in suburban Atlanta may have cracked one of diagnostics’ toughest challenges: early Lyme detection. Their CRISPR test shows promise for identifying infection long before standard tools can.

For laboratory leaders navigating a rapidly shifting diagnostics landscape, a new signal of future innovation is emerging from an unexpected place: a suburban high school lab in Georgia. Lambert High School’s student researchers have engineered a CRISPR-based prototype that may detect Lyme disease days after infection—a potential breakthrough that, if validated, underscores how quickly synthetic biology is advancing and how early the next generation is entering the field.

Clinical laboratory professionals will be happy to note the promising work that the next generation of lab scientists has started.

The students, all part of Lambert High School’s elite synthetic biology team near Atlanta, set out to solve what senior Claire Lee called one of medicine’s most stubborn blind spots. “We’re doing something in our high school lab that could potentially have a huge impact for, like, millions of people,” she said. “This thing could help save lives.”

Using CRISPR, the powerful gene-editing tool, the teens developed a prototype test that appears capable of detecting Lyme disease just two days after infection, far earlier than the two-week window required by current assays. Although based on simulated blood serum and still in proof-of-concept stages, their findings were compelling enough to earn praise from scientists and secure a top-10 finish at the International Genetically Engineered Machine (iGEM) competition in Paris.

High School Genetic Engineers With an Ambitious Plan

Led by team captains Sean Lee and Avani Karthik, the CRISPR-based system targets a protein produced in the earliest moments of Lyme infection. “One of the biggest problems with Lyme is the lack of, like, being able to diagnose it,” Karthik said. They even met one patient who went “15 years without a diagnosis.”

Their idea was to use CRISPR to cut away extraneous DNA, revealing the protein so it could be detected with a rapid, kit-style test which is much like the COVID-19 diagnostic format. The students also explored using a different CRISPR system to block Lyme-causing bacteria as a potential therapeutic alternative to antibiotics.

But the team’s vision initially met resistance. Biotechnology teacher Kate Sharer said she warned students, “This project in particular, I told them: this is very high risk, high reward.” She admitted, “I couldn’t imagine any of this working,” though she supported their efforts. External experts were similarly cautious. As co-captain Sean Lee recalled,

“They did tell us in the beginning that this might not be so feasible because you’re trying to tackle such a big thing.”

A Top-Notch Lab Inside a Public School

Lambert’s program stands out nationally. Its county-funded, corporate-supported lab rivals those at universities, and the school draws families who relocate specifically for opportunities like iGEM. The team—entirely Asian-American this year and mostly children of immigrants—accepts roughly 10 members from about 100 applicants. Students pitch project ideas, test into the program, and endure what the team calls “insanely long hours.”

In September, after months of work, the students saw the data they had hoped for. Their system flagged early Lyme markers in as little as two days. It wasn’t human-blood–validated, but it was enough to push the project forward.

They spent the last weeks before the competition building a website, compiling results and pulling all-nighters to finalize their presentation.

Showdown in Paris

Arriving in Paris in late October, Lambert joined more than 400 teams from around the globe. Projects ranged from designing Mars-ready crops to developing enzymes to fight indoor mold. Janet Standeven, who oversees iGEM’s high school division and founded Lambert’s program, said she believes synthetic biology education is essential.

Janet Standeven noted that when federal funding for statewide programs was cut, she felt “absolutely devastated” and “angry,” though a judge has since temporarily restored the support. (Photo credit: Engineering Biology Research Consortium)

Stanford professor and iGEM co-founder Drew Endy warned that the U.S. risks losing ground in biotechnology as China accelerates national investment. “It’s urgent that leadership of the next generation of biotechnology has a strong presence in America,” he said. After seeing Lambert’s work, he added, “They appear to have developed a better diagnostic for Lyme disease than anything I’ve seen before.”

China’s Great Bay team ultimately won the grand prize. Lambert, nominated in five categories, earned the award for best software tool and finished among the top 10 high school teams worldwide—the only American team to do so.

For the Lambert students, the recognition mattered, but the mission mattered more. As Claire Lee put it, working on a test with the potential to save lives made every long night “worth it.”

—Janette Wider

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