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Image: CellDx-Tissue is a qualitative IVD test that uses targeted NGS of DNA and RNA isolated from FFPE solid tumor tissue to analyze 517 cancer-associated genes (image credit: Adobe Stock)

FDA-Cleared Genomic Profiling Assay Guides Treatment Selection in Solid Tumors

Datar Cancer Genetics (DCG; Nashik, India), a global precision oncology company, has announced that its tissue-based comprehensive genomic profiling (CGP) assay for all solid tumors, CellDx-Tissue, has received U. Read more
19 May 2026 | Molecular Diagnostics
Image: sm-PORE-cupine helps scientists study how individual RNA molecules fold across different transcriptomes (biological samples) (Photo courtesy of A*STAR Genome Institute of Singapore (A*STAR GIS)

Nanopore Method Captures RNA Folding at Single-Molecule Resolution

RNA structure plays a central role in controlling gene expression, yet its dynamic, shape-shifting behavior makes it difficult to study at single-molecule resolution. Read more
19 May 2026 | BioResearch
Image: Findings show that ctDNA testing may help identify candidates for radiotherapy and refine management by signaling when a cancer has changed or developed resistance (image credit: 123RF)

ctDNA Blood Test Could Help Guide Radiotherapy in Patients with Limited Metastases

Selecting the right therapy for patients whose solid tumors have begun to spread remains a major clinical challenge. Read more
18 May 2026 | Molecular Diagnostics
Image: Graphical Abstract (Eldad D. Shulman et al., AI-predicted spatial transcriptomics unlocks breast cancer biomarkers from pathology, Cell (2026). DOI: 10.1016/j.cell.2026.04.023)

Rapid AI Tool Predicts Cancer Spatial Gene Expression from Pathology Images

Gene expression profiling can inform tumor biology and treatment selection, but spatial assays remain costly and time-consuming. Read more
18 May 2026 | Pathology
Image: New findings indicate that clonal hematopoiesis, an established prognostic factor in blood cancers, is associated with worse survival in patients with solid tumors (image credit: Adobe Stock)

Tumor Microenvironment Marker Linked to Worse Survival in Solid Tumors

Risk stratification across solid tumors remains difficult because outcomes can vary widely among patients with the same tumor type. Read more
18 May 2026 | BioResearch
Image: Signatera CDx uses ctDNA analysis to identify residual tumor-derived genetic material after definitive treatment (image credit: Adobe Stock)

FDA-Approved MRD Blood Test Guides Adjuvant Bladder Cancer Therapy

Muscle-invasive bladder cancer (MIBC) carries a substantial risk of recurrence after radical cystectomy, and selecting which patients require adjuvant therapy remains challenging. Read more
18 May 2026 | Molecular Diagnostics
Image: Findings show that genetic changes inside cancer cells may help explain why some patients with gallbladder cancer have poorer outcomes despite similar treatment (image credit: 123RF)

Tumor Genomic Profiling Identifies High-Risk Gallbladder Cancer

Gallbladder cancer is an aggressive biliary tract malignancy that often progresses silently and is frequently diagnosed at an advanced stage. Read more
18 May 2026 | Molecular Diagnostics
Image: The technology leverages routine slide preparations to deliver an individualized risk readout based on image-derived signals (photo courtesy of Valar Labs)

AI Pathology Test Receives FDA Breakthrough for Bladder Cancer Risk Stratification

Non–muscle invasive bladder cancer has highly variable outcomes, complicating surveillance and treatment planning. Read more
18 May 2026 | Pathology
Image: The study frames predictive genomic screening as both a clinical opportunity and a systems challenge (photo courtesy of Mayo Clinic)

Genome Sequencing Uncovers Hidden Genetic Risks in Healthy Adults

Genetic risk for serious diseases can go undetected in routine care, limiting opportunities for earlier intervention. Read more
18 May 2026 | Molecular Diagnostics
Image: FOXA1 is a highly sensitive diagnostic marker for prostate cancer including small cell carcinoma of the prostate (Zhao, J., Yao, J., Hosseini, H., et al. Histopathology (2026). doi.org/10.1111/his.70166)

Sensitive Protein Marker Aids Diagnosis of Small Cell Prostate Cancer

Accurate identification of aggressive prostate cancer subtypes can be difficult when tumors lose expression of lineage markers used in routine pathology. Read more
15 May 2026 | Molecular Diagnostics
Image: Cepheid’s Xpert GI Panel has received CE marking under tIVDR, providing fast and accurate detection of 11 clinically relevant gastrointestinal pathogens from a single patient sample (photo ccourtesy of Cepheid)

Rapid Multiplex PCR Test Detects 11 Gastrointestinal Pathogens from Single Sample

Cepheid’s Xpert GI Panel has received CE marking under the In Vitro Diagnostic Medical Devices Regulation (IVDR) and is expected to begin shipping to countries that accept the CE mark in the coming weeks. Read more
15 May 2026 | Molecular Diagnostics
Image: The findings suggest that people with mpox can transmit the virus even without clinical symptoms (image credit: Adobe Stock)

Study Finds Hidden Mpox Infections May Drive Ongoing Spread

Mpox continues to circulate despite vaccination, and many cases show no known link to a symptomatic partner. Read more
15 May 2026 | Microbiology
Image: Comparison of conventional B-cell acute lymphoblastic leukemia (B-ALL) fusion diagnostics (top) and Nanopore-based fusion detection (bottom) (Lin J, Opoku K, Litzow M, et al. J Mol Diagn. 2026. doi: 10.1016/j.jmoldx.2026.01.007)

Novel Algorithm Improves Detection of B-ALL Gene Fusions

B-cell acute lymphoblastic leukemia (B-ALL), the most common pediatric cancer, requires accurate genomic subtyping to guide risk-stratified treatment. Read more
15 May 2026 | Molecular Diagnostics
Image: Peripheral artery disease occurs when plaque partially or completely blocks arteries in the legs, arms, or pelvis, with limb loss among its serious complications (Photo courtesy of iStock)

Genetic Markers May Help Predict Amputation Risk in Peripheral Artery Disease

Peripheral artery disease (PAD) is a common condition in which plaque buildup narrows arteries in the legs, arms, and pelvis, and it can progress before symptoms are obvious. Read more
15 May 2026 | BioResearch

Channels

Clinical Chemistry

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Blood-Based Alzheimer’s Test Gains CE Mark for Amyloid Pathology Detection
FDA-Cleared Assay Enables Comprehensive Automated Testosterone Testing
CE-Marked Blood Biomarker Test Advances Automated Alzheimer’s Diagnostics
Image: Originally designed for lung cancer detection and resistance monitoring, the test also shows potential for identifying signals linked to pulmonary fibrosis (image credit: iStock)

Urine-Based Nanosensor Tracks Lung Cancer and Fibrosis Noninvasively

Lung cancer remains difficult to monitor for early progression and treatment resistance, while pulmonary fibrosis continues to pose major challenges for early diagnosis. Clinicians need repeatable, noninvasive... Read more

Molecular Diagnostics

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Realistic Mock Samples Aim to Speed Cervical Cancer Test Development
Molecular Marker Identifies Hormone Therapy Resistance Pathway in Prostate Cance...
Blood-Based “Ageing Clock” Helps Predict Dementia Risk and Earlier Onset
Image: Clarifying tumor microenvironment features and cancer-cell programs linked to treatment response could provide earlier insight into triple-negative breast cancer therapy (image credit: Shutterstock)

Gene Panel Shows Promise for Predicting Chemotherapy Response in TNBC

Triple-negative breast cancer (TNBC) is an aggressive subtype commonly treated with chemotherapy, yet outcomes vary widely among patients. Understanding the tumor features that drive this variability remains... Read more

Hematology

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Advanced CBC-Derived Indices Integrated into Hematology Platforms
Blood Test Enables Early Detection of Multiple Myeloma Relapse
Single Assay Enables Rapid HLA and ABO Genotyping for Transplant Matching
Image: Graphical abstract (Waclawiczek A, Leppä AM, Renders S, et al. Cell Stem Cell, 2026. doi:10.1016/j.stem.2026.04.012)

Stem Cell Biomarkers May Guide Precision Treatment in Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is an aggressive blood cancer that most often affects older adults and still carries a poor prognosis despite therapeutic advances. Venetoclax-based regimens have improved... Read more

Immunology

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Biomarkers and Molecular Testing Advance Precision Allergy Care
Point-of-Care Tests Could Expand Access to Mpox Diagnosis
T-Cell Senescence Profiling May Predict CAR T Responses
Image: The findings suggest IGRA control responses offer a scalable measure of immune function from a widely used clinical assay (image credit: Adobe Stock)

Routine TB Screening Test May Reveal Immune Aging and Mortality Risk

Immune aging is associated with weaker responses to vaccination, greater risks of infection, and higher levels of inflammation. Leveraging routinely ordered laboratory tests to quantify that responsiveness... Read more

Microbiology

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Molecular Urine and Stool Tests Do Not Improve Early TB Treatment in Hospitalized...
Rapid Antigen Biosensor Detects Active Tuberculosis in One Hour
Oral–Gut Microbiome Signatures Identify Early Gastric Cancer
Image: The initiative combines epidemiological and microbiological data with whole-genome sequencing to characterize circulating hospital lineages and resistance determinants (image credit: Shutterstock)

Large-Scale Genomic Surveillance Tracks Resistant Bacteria Across European Hospitals

Antimicrobial resistance (AMR) poses a growing threat to patient safety, with carbapenem-resistant Enterobacterales causing difficult-to-treat infections and leaving clinicians with limited therapeutic options.... Read more

Pathology

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New AI Tool Reveals Hidden Genetic Signals in Routine H&E Slides
AI System Analyzes Routine Pathology Slides to Predict Cancer Outcomes
New Tissue Mapping Approach Identifies High-Risk Form of Diabetic Kidney Disease
Image: ArteraAI Breast analyzes digitized histopathology images alongside patient clinical variables to produce an AI-derived risk score that provides prognostic insight into the likelihood of distant metastasis (Image credit: Adobe Stock)

FDA Clears AI Digital Pathology Tool for Breast Cancer Risk Stratification

Risk assessment at diagnosis is central to guiding therapy for early-stage, hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) invasive breast cancer, where overtreatment... Read more

Technology

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Fully Automated Sample-to-Insight Workflow Advances Latent TB Testing
Tumor-on-a-Chip Platform Models Pancreatic Cancer Treatment Response
New Platform Captures Extracellular Vesicles for Early Cancer Detection
Image: A new study shows how point-of-care testing can enhance health literacy and patient confidence (Photo courtesy of Adobe Stock)

Point-of-Care Testing Enhances Health Literacy and Self-Management in Chronic Disease

Limited access to general practitioners and pathology services can delay diagnosis and monitoring for people in regional and remote communities. Rapid, on-the-spot testing can shorten turnaround times... Read more

Industry

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Partnership Aims to Bring Risk-Guided CKD Care to Health Systems
Roche to Acquire PathAI for Up to $1.05 Billion to Strengthen AI Diagnostics Por...
FDA Clears Blood-Based Companion Diagnostic for Advanced Breast Cancer Therapy
Image: Ozelle Wins German Innovation Award Gold (photo courtesy of Ozelle)

AI-Powered Multi-Functional Analyzer Wins German Innovation Award

Hematology services are increasingly delivered across distributed care settings, where limited staffing and complex workflows can extend turnaround times. Advanced morphology review still often depends... Read more

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