AI, new diagnostics, and shifting care delivery models are among the clinical laboratory predictions for 2026.
By Alyx Arnett
With advanced molecular and biomarker assays reaching routine clinical use and artificial intelligence (AI) moving from pilots to daily practice, 2026 is shaping up to be a year when clinical laboratories don’t just support care—they help direct it.
Leaders across the field say the next chapter for laboratories will be defined by closer ties to care delivery and a reset in how labs handle data and quality day-to-day, with personalization at the center of that shift. “In 2026, clinical labs will sit at the center of medicine’s personalization revolution,” says Bill Kerr, MD, co-founder and CEO of Avalon Healthcare Solutions. “The most critical advances won’t just come from new assays, but from smarter use of the ones we already have, standardizing how genetic and biomarker data inform diagnosis, coverage, and care pathways.”
Lab leaders also point to rapid growth in blood-based testing, wider use of decentralized diagnostics, and increasing pressure to deliver results that are clear, consistent, and usable across care settings. Taken together, these shifts are pushing laboratories into new territory—reshaping how testing is delivered, how results are used, and how labs fit into the broader healthcare system.
AI’s Second Act in the Lab
In 2025, many clinical teams tested AI as a co-pilot tucked into analytics and reporting. In 2026, experts expect AI systems to take on a more active role in managing lab workflows, while still with guardrails and human oversight. “Agentic AI will build on [today’s co‑pilots], extending their capabilities along a continuum of agency,” says Kalim Saliba, chief product officer at Dotmatics. He anticipates systems that “plan and reason through multi-step processes by choosing which tools, APIs, or models to use to reach an outcome,” while keeping clinicians in the loop to ensure transparency and trust.
On the diagnostic front, Tina Liedtky, president of transplant diagnostics at Thermo Fisher Scientific, says, “AI holds great potential to enhance transplant diagnostics by improving the precision and speed of donor–recipient matching and predicting rejection risk before it occurs.”
Additionally, Brad Moore, president and CEO of Roche Diagnostics North America, expects AI to play a growing role in improving efficiency and precision across testing and decision support. He points to momentum in the integration of AI into digital pathology, “in which algorithms assist in pattern recognition, reduce scoring subjectivity, and provide high-value insights for cancer diagnosis and precision medicine.”
Those capabilities are reshaping the decision to digitize, says Nathan Buchbinder, co-founder and chief strategy officer at Proscia, citing gains in workflow efficiency, diagnostic precision, and operational resilience. “As we enter 2026, the labs that haven’t gone digital now have an especially strong case for making the change,” he says. Ronald A. Blum, PhD, vice president of science and technology at OmniPathology, also expects digital pathology to move from early adopters to broader mainstream, bolstered by faster scanners, maturing image management, and AI tools that triage fields of view and quantify features. Reimbursement remains a work in progress, but many labs are documenting utilization with existing CPT Category III add-on codes to build the case for payment, Blum notes.
As AI becomes more widely used, “the winners will be the organizations that deliver the predictive power of models directly into scientific context,” says David Gosalvez, PhD, chief strategy officer at Revvity Signals. He expects federated learning—“a framework where pharma companies can benefit from collective intelligence without ever sharing raw data”—to shift from pilots to standard practice by the end of 2026, “enabling secure cross-company model refinement and accelerating how the industry innovates,” he says.
Additionally, better AI copilots might be next. “Right now, AI copilots for doctors haven’t yet lived up to their promise—but they absolutely will,” says Nata Savaścienka, co-founder and chief product officer at BloodGPT. As models are refined with real clinical feedback and medically curated data, she expects decision-support tools to become indispensable.
Blood-Based Alzheimer’s Testing Scales Up
Few areas have moved from specialty to frontline practice faster than Alzheimer’s diagnostics. Stakeholders anticipate the primary care setting will become the first stop for an initial rule-in or rule-out assessment using blood-based biomarkers.
“It is an exciting time in the area of brain health,” says Michael Racke, MD, medical director for neurology at Quest Diagnostics. He expects the future of Alzheimer’s risk assessment and diagnosis to involve a “variety of testing modalities and biomarkers, including blood, cognitive assessments, and imaging,” with blood-based markers increasingly reducing reliance on PET and lumbar punctures.
Roche’s Moore points to US Food and Drug Administration (FDA)-cleared assays now available for use in primary care to help rule out Alzheimer’s pathology as a major step toward broader access. Still, he says, successful adoption of these blood-based biomarker tests in clinical practice requires clear guideline recommendations and closer collaboration between primary and specialty care. “Widespread availability of these assays in clinical laboratories will be essential to ensuring that patients benefit from these timely, accessible, and less invasive testing options,” he says.
Cancer Diagnostics Evolve Across Screening and Monitoring
Oncology laboratories enter 2026 at a point of transition, with new screening approaches, growing use of blood-based monitoring, and changing patient expectations reshaping how cancer testing is delivered.
“To screen or not to screen, that is the question,” says Yuri Fesko, MD, senior vice president and chief medical officer at Quest Diagnostics, reflecting on the long-running debate around prostate cancer PSA-based screening. He expects next-generation biomarkers such as IsoPSA, which evaluates structural changes in PSA proteins, to “become standard of care to help bridge this divide.” He believes inclusion in National Comprehensive Cancer Network guidelines and growing evidence for biomarker panels as adjuncts to clinical pathways could help labs standardize reflex algorithms and reduce unnecessary biopsies while capturing clinically significant disease.
Meanwhile, minimal residual disease (MRD) testing is maturing rapidly. “I believe 2026 will bring further growth of ultrasensitive MRD testing, defined by greater sensitivity and strong clinical evidence,” says Richard Chen, MD, chief medical officer and executive vice president of research and development at Personalis. He anticipates broader integration of MRD with genomic profiling and imaging from diagnosis through long-term surveillance, with more oncologists incorporating blood-based monitoring into routine follow-up. As datasets accumulate, he believes MRD is likely to gain traction as an endpoint in clinical trials, potentially accelerating development timelines.
Additionally, the patient population itself is changing. “The recent rise in cancer diagnoses among young people is making plenty of headlines,” says Thomas P. Slavin Jr., MD, chief clinical officer of molecular oncology and medical director at Haystack Oncology, a Quest Diagnostics company. He expects this demographic’s propensity toward personalized healthcare tools to drive adoption of precision diagnostics, from treatment selection and trial matching to hereditary testing and ctDNA-based MRD. For labs, he says that means building capacity for high-sensitivity assays, ensuring equitable access, and designing reports that non-oncology specialists—and patients—can understand.
Companion diagnostics are expected to increasingly anchor these workflows. “We anticipate more targeted and personalized therapies being used to treat chronic and rare conditions, due in part to the proliferation of multiomics in companion diagnostics,” says Madhuri Hegde, PhD, senior vice president and chief scientific officer at Revvity. She says integrated genomics, proteomics, and metabolomics can improve target validation and patient selection while reducing attrition in clinical trials, placing labs at the fulcrum of precision therapy development and deployment.
Testing Moves Beyond the Central Lab
In 2026, more clinical testing is expected to happen outside traditional lab settings, with point-of-care diagnostics leading the shift. For sexually transmitted diseases, Roche’s Moore says point-of-care testing will “revolutionize the management,” citing rapid, precise diagnostics in accessible settings to support on‑visit treatment and curb transmission. For respiratory infections, he points to multiplex panels as standard practice at the point of care and in the lab, with digital reflex testing enabling tiered reporting from a single run to maximize diagnostic yield and resource stewardship.
Screening at scale is expected to expand well beyond respiratory disease, according to Salvatore Viscomi, MD, CEO and co-founder of Carna Health. “In 2026, clinical laboratories should prepare for a significant expansion in point‑of‑care testing solutions being increasingly used outside traditional settings for population health efforts,” says Viscomi. He highlights global programs that integrate point-of-care testing with digital platforms for hypertension and chronic kidney disease, enabling earlier diagnosis, lifestyle interventions, and coordination with care teams through EHR integration.
Self-collection is also moving from niche to normalized in defined use cases. “We implemented self‑collection options for genital tract infections in late 2024 and for HPV in early 2025,” says Damien Alagia III, MD, senior medical director for advanced diagnostics and women’s health at Quest Diagnostics, noting strong patient adoption. He emphasizes that self-collection supplements rather than replaces clinical evaluation, but can increase access for women not getting screened, particularly in rural areas.
On the high-complexity end, next-generation sequencing “is moving out of major academic centers faster than most people realize,” says Luca Quagliata, PhD, vice president and global head of medical affairs for clinical sequencing and oncology at Thermo Fisher Scientific. He sees automation, simpler workflows, FDA‑cleared assays, and AI support lowering barriers, with community and regional hospitals bringing core testing in‑house while relying on remote expert review for complex cases.
Operational Pressure Reshapes Lab Workflows
The labor crunch remains acute, and leaders warn that it will not resolve without cultural and technological change. “Only 12% of laboratory technologists [reported] they were highly likely to remain in the diagnostics field,” says Bryan Hanson, senior vice president for clinical labs and transfusion medicine at QuidelOrtho, citing the company’s 2024 workplace insights report.
He argues that greater personal recognition, modern training, and investments in automation that reduce manual, repetitive work can boost morale and retention. “By nurturing a supportive culture and investing in advanced technology, we create the foundation to deliver consistently increased job satisfaction, and with it, high‑quality patient care,” he says.
With staffing pressures unlikely to ease in 2026, labs are expected to lean harder on tools that improve day-to-day efficiency. “For clinical labs, operational efficiency has become as important as analytical accuracy,” says Greer Massey, PhD, chief scientific officer at Molecular Designs. She sees growing adoption of ready‑to‑use PCR panels and workflow simplification to cut errors and turnaround time.
As for automation, Ellie Mahjubi, vice president and general manager of protein and cell analysis at Thermo Fisher Scientific, says it will “give scientists more time to think, create, and innovate,” while multiomics and spatial methods will deepen biological insight.
Additionally, financial pressure is expected to increase scrutiny of laboratory operations in 2026, prompting labs to be more explicit about how their work supports patient care, says Sharon Bracken, head of diagnostics at Siemens Healthineers. “The year ahead will be a pivotal one for laboratories operating under limited resources to clearly convey and amplify their value,” she says. “The challenge we observed, however, and hope to change, is that lab professionals tend to play down their contributions to the health system.”
However, she points to research her team conducted with more than 400 physicians, which showed that lab results play a significant role in clinical decision-making, including decisions that drive the use of other, more resource-intensive hospital services.
For some laboratories, those pressures are making scale harder to avoid. “Mergers and acquisitions will continue in 2026,” says OmniPathology’s Blum, citing shrinking reimbursements, tighter regulations, and workforce shortages. Still, scale can enable purchasing power and deeper specialization, he says, positioning large laboratories to support complex oncology programs and clinical trials. Independent and regional labs may mitigate risk through partnerships that share infrastructure, digitization investments, and quality systems, he says.
Data Expectations Rise
In the coming year, laboratories are expected to face much tighter expectations around how data is shared, structured, and used across the healthcare system.
For one, Suren Avunjian, CEO of LigoLab, says, “Interoperability will move from goal to requirement.” Avunjian says labs will need to clean and standardize their data to link with EHRs, pathology images, and genomic results, while also leveraging the latest APIs. Avunjian expects privacy laws to push the use of federated learning and synthetic data to share insights safely. “Only labs with good data governance and clear audit trails will benefit from these new models,” says Avunjian. “Treating data as an asset, not an afterthought, will define the leaders of 2026.”
He also expects regulations and payer rules to tighten in 2026, requiring labs to have systems that can share accurate data with insurers in real time. He believes reimbursement will depend more on measurable outcomes. “Labs treating billing as a back-end process and waiting to start billing after the report is released will fall behind,” he says. “Platforms that link order entry, upfront demographic checking, coding, and claim submission in one platform will avoid delays and protect revenue.”
Additionally, risk-managed quality control (QC) is expected to continue growing in 2026, according to John C. Yundt‑Pacheco, senior principal scientist at Bio‑Rad Laboratories, “driven by a greater appreciation of the benefits of risk-managed QC for both the lab and its clients as well, as the increased focus on risk management in the 2022 version of ISO 1518 anchored in ISO 15189:2022.” He expects continued refinement of tools to estimate the size of out‑of‑control events and the number of affected specimens, enabling right‑sized recovery strategies. Severity of harm, informed by clinician input and international surveys, he says, is becoming a key variable in designing QC plans that protect patients while optimizing resources.
For multimarker and multimodal diagnostics, harmonized pre-analytics and longitudinal data packages will become prerequisites. “Next year, labs will prioritize diagnostics that adapt to real‑world challenges like variable pre‑analytics, staffing, and patient access,” says Lindsey Mette, director of medical affairs at Quanterix. She expects a shift toward panels with algorithmic outputs and assays that perform across matrices and decentralized collection methods.
Jorge Marques Signes, PhD, vice president of accelerator and clinical services at Quanterix, foresees decentralized, multimodal biomarker measurement crossing “from aspirational to operational,” with remote sample collection, such as dried blood spot and capillary workflows, demonstrating “sufficient correlation to support clinical-grade measurement of low-abundance neurology and oncology markers.”
Additionally, Miguel Tam, director of product management for life science reagents at BioLegend, part of Revvity, expects greater standardization in clinical research to play a growing role in how reliably new diagnostics translate into routine use, improving consistency and efficiency as tests move from development into the clinic.
Public Health Demands Pull Labs in New Directions
Laboratories are expected to play a more visible role beyond individual patient testing as public health demands, policy expectations, and real-world care challenges continue to converge. This includes closer coordination with public health agencies. “Clinical and public health laboratories will collaborate more closely, sharing surveillance data to track antimicrobial resistance, emerging pathogens, and community health trends,” says Rodney E. Rohde, PhD, a regents’ professor at the Texas State University System. He predicts a greater role for laboratories in emergency response and One Health initiatives, positioning lab professionals as essential voices in biosecurity and resilience.
“Rapid molecular and genomic tools will become standard, allowing labs to detect resistant pathogens and outbreaks in real time—transforming infection prevention and treatment decisions,” says Rohde. “We are moving quickly to more personalized medicine where patients want and demand input.”
An expanded public-health role also brings new urgency to areas where diagnostics must keep pace with rapidly changing threats. The opioid crisis is one such front, according to Jared Jaeger, PhD, clinical science liaison at QuidelOrtho. “Many new synthetic opioids evade detection by standard drug screens, requiring advanced technologies such as mass spectrometry to identify them,” says Jaeger. As new analogs appear and potency rises, he says emergency departments will need expanded toxicology panels, updated instrumentation, and staff training to keep pace with shifting presentations and increasingly narrow windows for intervention.
Beyond acute response, laboratories are also being pulled further into long-term population health management. Cardiometabolic testing is one example, where labs are being asked to look beyond single endpoints. “In 2025, we saw many individuals focus on weight loss as a means of potentially improving their cardiometabolic health,” says Mouris Saghir, PhD, vice president and general manager for cardiometabolic, endocrine, and wellness at Quest Diagnostics.
Saghir expects a broader wellness perspective, with routine testing tracking muscle maintenance and nutrient status alongside weight changes—particularly as GLP-1 receptor agonists reshape dietary patterns. For laboratories, Saghir says that shift means offering quality-controlled vitamin and nutrient testing aligned with clinical guidance to support patient goals without driving unnecessary utilization.
Newborn screening is another area where public health expectations are expanding. Anna Godenhjelm, general manager of reproductive health at Revvity, points to advances in cell and gene therapies as a key driver of broader screening panels, with next-generation sequencing gaining traction as programs look to identify rare genetic diseases earlier. While questions around cost, ethics, and implementation remain, she expects continued momentum toward more comprehensive and equitable newborn screening as new treatments make early diagnosis increasingly actionable.
Operational realities are also shaping how laboratories plan for the future, including growing pressure to address sustainability. “We can expect to see industry-wide shifts toward more sustainable options in laboratory equipment at all stages of development and use,” says Noreen Hong, vice president and general manager for growth, protection, and separation in laboratory products at Thermo Fisher Scientific. With new regulations phasing out certain fluorinated refrigerants beginning in 2026, Hong says labs and suppliers will need to plan for replacement technologies, clearer environmental metrics, and end-of-life strategies that reduce waste.
A Lab-Centered Future
From agentic AI and community next-generation sequencing to blood-based Alzheimer’s testing and ultrasensitive MRD, laboratory leaders say the impact of new diagnostics in 2026 will hinge less on availability than on how well these tools are integrated into everyday care. That includes clear interpretation, consistent quality, and practical use within clinical workflows. As Kerr puts it, the challenge is ensuring that every test is “ordered for the right reasons and at the right time…and understood in the full clinical picture.”
Looking ahead, stakeholders expect laboratories that succeed to place greater emphasis on data stewardship, risk-managed quality, and workforce development. “Laboratory testing will serve as both a scientific standard and a public trust anchor,” says Misty Phillips, MLS (ASCP), MB, technical laboratory educator at Thermo Fisher Scientific.
Rather than replacing expertise, leaders predict new tools will continue to reshape how laboratory professionals contribute to care—supporting faster decisions, clearer communication, and more coordinated use of diagnostic information across the health system. “Laboratory professionals are emerging as strategic leaders in healthcare delivery, not just support staff,” Phillips adds.
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Alyx Arnett is chief editor of CLP. Questions or comments? Email [email protected].
