New RNA Entities Found in Human Microbiome Challenge Definitions of Viruses
Researchers have identified thousands of protein-free, circular RNA molecules living inside human-associated bacteria, raising new questions for microbiology labs about how life is classified. Laboratory leaders accustomed to classifying organisms as bacteria,...
AI Cancer Diagnostics Struggle with Equity, Study Finds
Accuracy gaps in pathology AI affecting nearly 30% of diagnostic tasks highlight risks for clinical decision-making and patient outcomes, according to new research. A new study is raising important questions for pathologists as artificial intelligence (AI) becomes...
Ontario Group Calls for Funding to Expand Lab Student Training Programs
Ontario medical labs face critical staffing shortages, delaying test results. MLPAO urges $6M funding for student training to expand workforce capacity. Medical laboratories across Ontario are facing persistent staffing shortages that are delaying test results and...
Researchers Integrate Genomics, Proteomics, and EHR Data to Identify Cancer Risk Proteins and Prevention Drugs
Investigators identified more than 100 proteins linked to inherited cancer risk and dozens of existing drugs that could be repurposed for cancer prevention. Researchers at Vanderbilt University Medical Center (VUMC) and the University of Calgary have developed a new...
FDA Proposes Reclassifying Oncology Companion Diagnostics, Potentially Easing Approval Path and Expanding Patient Access
The agency says shifting certain companion diagnostic tests from Class III to Class II could reduce regulatory burden, shorten review timelines, and encourage more manufacturers to enter the market. The US Food and Drug Administration (FDA) has released a proposal...
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...
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...
ASCP 2024 Vacancy Survey Shows Laboratory Staffing Shortages Persist Despite Pandemic-Era Gains
Vacancy rates in U.S. medical laboratories have declined since COVID-19 highs, but ASCP’s latest survey finds staffing levels remain well above pre-pandemic norms as retirements accelerate and recruitment challenges deepen. The American Society for Clinical...
VA Awards Baylor Genetics Multi-Year Contract for Nationwide Pharmacogenomic and Germline Testing
What the VA’s New Baylor Genetics Contract Means for Clinical Lab Leaders. For clinical laboratory leaders tracking the growing role of precision medicine in federal healthcare systems, the US Department of Veterans Affairs (VA) has taken another significant step...
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...
New Open-Source Tool Aims to Make Sepsis Prediction Models More Transparent for Clinicians
A new open-source platform enhances the interpretability of CBC-based machine-learning models for sepsis prediction, offering improved transparency and clinical utility. Laboratory leaders watching the evolution of clinical AI tools now have a new development to...
Top 10 Most Influential US Pathologists on Twitter/X Revealed
New ranking highlights the pathologists with the biggest social media reach—and what their influence means for diagnostics, research, and industry engagement. A new analysis identifies the most influential US pathologists on Twitter/X, highlighting a growing link...
Transform Trial Begins: UK’s Largest Prostate Cancer Screening Study Targets Earlier, Safer Diagnosis
With 300,000 men expected to enroll, researchers hope the trial will redefine prostate cancer screening and reduce preventable late-stage disease. The UK has launched the £42 million Transform trial, the largest prostate cancer screening study in decades—marking a...
New Dual-RNA Therapy Takes Aim at KRAS, Cancer’s Toughest Target
Researchers in Singapore unveil a breakthrough RNA strategy that simultaneously silences KRAS mutations and activates immune defenses in hard-to-treat tumors. As precision oncology moves deeper into RNA-based and immune-modulating therapies, clinical laboratories are...
Abbott Moves to Acquire Exact Sciences
Abbott has announced a $21 billion deal to acquire Exact Sciences, which could accelerate early cancer detection, expand at-home testing, and reshape the diagnostics landscape globally. Abbott announced on Nov. 20 that it has entered a definitive agreement to acquire...
At the AMP 2025 Annual Meeting, Hundreds Jam Room to Hear About cfDNA Testing
Association for Molecular Pathology gathering also served up an advocacy push for RESULTS Act passage. The Association for Molecular Pathology (AMP) 2025 Annual Meeting brought together just over 3,000 attendees, and an estimated 420 of them—an impressive 14% of total...
UC San Diego Health Launches First US Blood Test for Testicular Cancer, Setting New Standard for Lab Diagnostics
The CAP- and CLIA-validated microRNA-371a-3P assay promises earlier detection, fewer CT scans, and more precise treatment decisions for a high-risk patient population. According to a press release, UC San Diego Health has become the first health system in the United...
PAMA Reform Gains Momentum: Inside the Fight to Protect Clinical Labs
Congress included lab relief in its latest funding bill, signaling growing awareness of PAMA’s impact. Here’s what lab leaders should do next. During a Nov. 12 webinar hosted by Dark Daily, the discussion centered on why a small laboratory provision ended up in the...
New ADLM Guidelines Give Labs a Roadmap for Accurate Coagulation Testing in DOAC Patients
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...
Drug-Resistant Infections Poised to Rise in Europe’s Elderly, Modeling Study Warns
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...
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...
IVD Market Consolidates as QIAGEN, Hologic, and Siemens Lead New Wave of M&A
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,...
Shutdown Puts RESULTS Act and Lab Relief on Hold Until Congress Reopens
The bipartisan RESULTS Act, designed to overhaul Medicare’s payment system for clinical laboratory testing, is on hold amid the ongoing government shutdown. With cuts of up to 15% set to hit 800 common lab tests in 2026, laboratory leaders warn that the delay...
Public Trust in CDC Falls to Record Low, Opening Door for Labs to Lead Local Health Response
A new KFF poll shows Americans’ trust in the CDC has dropped to its lowest point since COVID-19, creating an opportunity for clinical laboratories to become trusted local voices in public health. An article from CIDRAP recently reported that public trust in the...
Global AMR Crisis Deepens, WHO Calls on Labs to Strengthen Data and Diagnostics
Drug-resistant infections are outpacing treatments, and WHO says laboratory leaders are vital to protecting antibiotic effectiveness. For laboratory leaders, the latest WHO report on antimicrobial resistance (AMR) underscores just how critical diagnostic testing, data...
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