From test selection to mitigation strategies, the expert panel outlines practical steps to protect result integrity and streamline decision-making.
The Association for Diagnostics & Laboratory Medicine (ADLM) has released new expert guidance aimed at helping laboratory leaders navigate one of the most challenging gray zones in coagulation testing: how to accurately assess clotting status in patients taking direct oral anticoagulants (DOACs).
As DOAC use continues to grow across healthcare systems, the recommendations give labs a clearer framework for selecting appropriate assays, managing interferences, and strengthening communication with clinical teams.
According to a press release, DOACs are now among the most commonly prescribed anticoagulants, used to prevent strokes, pulmonary embolisms, deep vein thrombosis, and other clotting-related conditions. While these medications reduce the need for routine monitoring—one of their key advantages over traditional agents like warfarin—they still intersect with the laboratory in critical, high-stakes scenarios. Patients on DOAC therapy often require coagulation testing during emergencies involving heavy bleeding, when clinicians are investigating potential clotting disorders, or before surgeries where bleeding risk must be carefully controlled.
Challenges for Lab Professionals
For lab professionals, these situations pose significant operational and interpretive challenges. Because DOACs act directly on the same clotting factors measured in many standard assays, they can distort results or create the appearance of coagulopathies that are not truly present. ADLM’s new guidance condenses a complex body of research into a clear set of recommendations designed to help labs safeguard accuracy while supporting fast clinical decision-making.
A major takeaway for lab leaders is the recommendation to avoid clot-based assays whenever possible for DOAC-treated patients. The document details which tests are susceptible to interference and which remain reliable, providing a decision-making framework that labs can incorporate into protocols, test menus, and clinician education efforts. This clarity is especially valuable in high-volume settings where turnaround expectations and operational pressures are significant.
Lindsay A.L. Bazydlo and the other authors also noted, “Communication and collaboration with the laboratory leadership and staff is strongly suggested prior to testing. The laboratory medical director can provide guidance to the clinical team on current methodologies and how to interpret results for patients on DOACs.” (Photo credit: University of Virginia)
When Clot-Based Testing Is Unavoidable
Still, the guidance recognizes that avoiding clot-based assays is not always feasible.
For such cases, the expert panel outlines practical mitigation steps that labs can adopt. These include using agents that neutralize DOAC effects in vitro, coordinating temporary discontinuation of DOAC therapy prior to testing when medically appropriate, or facilitating a short-term switch to low-molecular-weight heparin. Each option requires careful planning, but they give laboratories concrete tools to reduce result distortion.
Perhaps most importantly for lab leadership, the guidance underscores the need to strengthen communication pathways with clinicians. Coagulation testing in DOAC patients is inherently multidisciplinary: labs need timely information on medication type and timing, while clinicians rely on labs to explain assay limitations and interpretive considerations. The document calls for labs to proactively engage with providers through education, consultative services, and updated testing algorithms to ensure both sides are aligned.
For laboratory leaders managing quality, workflows, staffing, and clinician expectations, ADLM’s guidance arrives at a crucial time. As DOAC use rises and clinical teams increasingly depend on laboratories to provide rapid, accurate data in emergent situations, the recommendations offer a roadmap for reducing diagnostic risk, standardizing best practices, and elevating the lab’s role as a strategic partner in patient care.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Researchers from the London School of Hygiene and Tropical Medicine project that bloodstream infections caused by resistant bacteria will spike among adults aged 74 and older by 2030.
For laboratory leaders, new modeling research underscores a mounting challenge in infectious disease surveillance: the rise of drug-resistant bloodstream infections (BSIs) across Europe. According to a study published in PLOS Medicine, the rate of BSIs caused by antimicrobial-resistant bacteria is expected to climb sharply over the next five years—driven largely by an aging population.
A news release from CIRAP explained that researchers from the London School of Hygiene and Tropical Medicine analyzed data from more than 12 million blood cultures collected across 29 European countries between 2010 and 2019. Using those findings, they projected BSI rates through 2050 across 38 bacteria–antibiotic combinations, revealing what they called a “clear and consistent relationship” between infection rates, age, and sex. “With substantial sub- and national-variation, the consistency and clear shape of some relationships provide evidence for the inclusion of age and sex in any predictions of future AMR burden,” the authors wrote.
BSI Rates Expected to Increase
The study’s forecasts are sobering. By 2030, BSI rates are expected to increase dramatically among older adults (74 years and up), while stabilizing or even declining among younger groups. Incidence is also predicted to rise faster in men than in women across most bacterial species. Even under optimistic public health scenarios, the team found that achieving a 10% reduction in infections by 2030 would only be feasible for about two-thirds of bacteria–antibiotic pairings.
Senior study author Gwen Knight, PhD, noted, “Combining these factors with demographic and infection trends really highlighted how challenging it will be to reverse the steady rise in bloodstream infections across Europe.” (Photo credit: London School of Hygiene and Tropical Medicine)
For laboratories, the findings highlight the growing importance of targeted surveillance, age-stratified reporting, and real-time resistance data to guide treatment and public health interventions. As Knight and her colleagues conclude, intervention strategies must account for demographic shifts—because the burden of resistance, much like the population it affects, is rapidly aging.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
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.
“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.
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.
The IVD industry’s consolidation surge continues unabated, as advances in AI-driven genomics and a flurry of private equity deals reshape the sector for a data-driven decade ahead.
The in vitro diagnostics (IVD) market is entering a new phase of transformation, defined by innovation at the technology level and consolidation at the corporate level, as strategic buyers and investors reshape the competitive landscape.
In the latest move, QIAGEN announced plans to acquire Parse Biosciences for up to $280 million, a deal that will expand QIAGEN’s Sample technologies into the rapidly growing single-cell sequencing market. The acquisition gives QIAGEN access to Parse’s Evercode technology and massive-scale datasets—critical assets as AI-driven drug discovery and predictive biology become central to life sciences. The move underscores QIAGEN’s bet that future diagnostic and therapeutic breakthroughs will hinge on scalable, data-rich technologies rather than traditional instrument-based models.
The Dark Report noted recently in its ranking of top IVD companies that Qiagen was #10, a jump of three spots up from its prior ranking.
Alex Rosenberg, PhD, CEO and co-founder of Parse Biosciences added, “As our team joins QIAGEN, we want to accelerate that mission and extend the reach of our technology to more customers around the world. QIAGEN’s strong commitment to Sample technologies and its global infrastructure make it an ideal partner for our next stage of growth.” (Photo credit: Parse Biosciences)
M&A Highlights
The QIAGEN–Parse deal follows months of high-profile M&A activity reshaping the diagnostics sector.
In October, Hologic agreed to an $18.3 billion buyout by Blackstone and TPG, marking one of the largest private equity transactions in healthcare this year. The move takes a top-15 IVD and imaging company private, reflecting both investor confidence in the steady revenues of women’s health diagnostics and a broader pattern of capital consolidation in the space. Analysts suggest that private equity firms are seeking predictable, cash-generating platforms while large corporations increasingly focus on growth through specialization or divestment.
That strategy is on display at Siemens Healthineers, which is reportedly exploring a $7 billion divestiture of its diagnostics division to firms including Blackstone, KKR, and CVC Capital Partners. Such a sale would streamline Siemens’ portfolio around imaging and oncology technologies, while potentially placing one of the world’s largest IVD suppliers under new ownership.
Taken together, these deals highlight a defining moment for the diagnostics industry. Major corporations are repositioning their portfolios around data, AI, and precision medicine, while investors are moving aggressively to capture value in an industry that proved its resilience during and after the pandemic.
For laboratory leaders, the implications are clear: consolidation is accelerating, supply chains and vendor relationships may shift, and innovation is increasingly concentrated among fewer, but more powerful, players.
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This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Roche’s SBX technology just helped Broad Clinical Labs set a GUINNESS WORLD RECORD for the fastest DNA sequencing ever.
According to a recent press release, for laboratory leaders tracking the next wave of genomic innovation, Roche’s latest advancements in sequencing technology could signal a major shift in research capabilities. At the 2025 American Society of Human Genetics (ASHG) Annual Meeting, the company unveiled new data and collaborations around its Sequencing by Expansion (SBX) platform—a system designed to deliver faster, longer, and more flexible reads.
This technology’s growing adoption by research institutions suggests it could soon reshape how labs approach complex multiomic analysis, precision oncology, and translational research.
World Record Broken
A highlight of the 2025 ASHG Annual Meeting was the GUINNESS WORLD RECORD achievement by Broad Clinical Labs, which used SBX to complete the fastest human genome sequencing to date, processing a sample from DNA extraction to final variant call file in under four hours. This record, achieved in collaboration with Roche Sequencing Solutions and Boston Children’s Hospital, surpassed the previous mark of just over five hours, demonstrating SBX’s ability to deliver rapid, high-quality results.
Mark Kokoris, inventor of the SBX chemistry and head of SBX Technology at Roche commented, “Breaking the GUINNESS WORLD RECORD is a remarkable achievement.” (Photo credit: Roche)
Roche also announced a new collaboration with the Wellcome Sanger Institute, which will conduct multi-project evaluations of SBX across applications such as Bulk RNA sequencing, where longer reads and higher throughput could uncover complex features like spliced isoforms. This partnership adds to a growing network of collaborations that include the Hartwig Medical Foundation, Genentech, The University of Tokyo, and the Broad Institute, reflecting widespread scientific interest in applying SBX across diverse research domains.
Further innovations include progress in methylation mapping using SBX-Duplex, which reads both DNA strands simultaneously, paired with TET-assisted pyridine borane sequencing (TAPS) from Watchmaker Genomics. This workflow enhances accuracy in detecting DNA methylation and holds promise for applications such as liquid biopsy-based cancer detection and novel biomarker discovery.
In another collaboration, researchers at the University of Tokyo leveraged SBX’s speed and flexibility for spatial sequencing of lung cancer tissue, achieving roughly 15 billion reads in just one hour. Roche also presented a target enrichment method using the SBX-Simplex workflow, which employs Unique Molecular Identifiers (UMIs) to generate highly accurate reads from minimal input, an approach that could be particularly valuable in oncology research requiring deep sequencing coverage.
For diagnostics and research laboratories, Roche’s progress with SBX represents more than a technical milestone, it points to new operational opportunities. Potentially faster turnaround times, deeper insights across multiple molecular layers, and improved workflows could help labs expand their research portfolios and strengthen partnerships in precision medicine. As sequencing continues to evolve from discovery to real-world application, forward-thinking lab leaders will want to keep an eye on how SBX’s scalability and speed might redefine their own genomic testing strategies.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
