Category: Diagnostic Technologies

Diagnostic Technologies

Roche Launches Algorithm Suite for Chronic Liver Disease Management

The panel integrates biomarker testing and digital tools to support fibrosis risk assessment and liver cancer surveillance.

Diagnostic Technologies

FDA Approves Companion Diagnostic to Identify NSCLC Patients Eligible for Tepmetko

The tissue-based test identifies patients with MET exon 14 skipping alterations eligible for treatment with tepotinib.

Diagnostic Technologies

How Labs Are Driving the Andes Hantavirus Outbreak Response

Laboratories are leveraging established diagnostic and surveillance tools to track the Andes hantavirus outbreak linked to a cruise ship, with experts noting no evidence of widespread community transmission or efficient airborne spread.

Anatomic Pathology

FDA Grants Breakthrough Designation to AI Bladder Cancer Prognostic Test

The FDA has granted Breakthrough Device Designation to Valar Labs’ Vesta Bladder Risk Stratify Dx, the first AI-powered digital pathology prognostic test for bladder cancer.

Digital Pathology

Labcorp Launches AI-Powered App to Help Patients Understand Test Results

Labcorp has launched MyLabcorp, a mobile app that uses OpenAI models to help patients interpret lab results and track health trends. The company cites growing consumer demand for AI-powered health information and clinical context.

Clinical Chemistry

Routine Lab Tests May Help Identify Physical Effects of PTSD

Researchers at Mass General Brigham identified 16 routine lab markers, including cholesterol and glucose, linked to PTSD’s physical effects, suggesting standard tests could aid in assessing the disorder’s multi-organ impact.

Flow Cytometry

Bio-Rad Expands Antibody Labeling Kits for Flow Cytometry and Western Blot

Bio-Rad has expanded its TrailBlazer StarBright Dye Label Kits to 32 options, now available in Europe for flow cytometry and fluorescent western blot applications, according to the company.

Hematology & Serology

What the Hemostasis Staffing Crunch Is Changing About Analyzer Selection

Staffing shortages are prompting clinical labs to prioritize automation, standardization, and preanalytical safeguards when selecting hemostasis analyzers.

Immunoassay

Roche Receives CE Mark for Alzheimer’s Disease Blood Test

Roche has received CE mark approval for its Elecsys pTau217 blood test, designed to aid in Alzheimer’s disease diagnosis by detecting amyloid pathology in patients with cognitive decline.

Mass Spectrometry

New Data Supports Multi-Omic Blood Test for Early Ovarian Cancer Detection

AOA Dx presented data at AACR 2026 supporting its AKRIVIS GD Test System, a multi-omic, blood-based assay for early ovarian cancer detection in symptomatic women, reporting an AUC of 0.92 in clinical controls.

Microbiology

Common Lyme Disease Tests Miss Majority of Early Cases, Study Finds

New research indicates that standard and modified two-tiered testing algorithms fail to detect infection in up to 78% of patients during the early stages of the disease.

Molecular Diagnostics

Blood Test Outperforms Ultrasound in Early Liver Cancer Detection, Study Finds

A multicenter clinical trial found the HelioLiver blood test detected early-stage liver cancer with 71.9% sensitivity, outperforming ultrasound’s 36.8%.

Point-of-Care

Roche Receives FDA Clearance for Point-of-Care Bordetella Test

The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.

Urinalysis & Toxicology

Rapid Urine Test Identifies Effective UTI Antibiotics in Under Six Hours

A rapid urine test identified effective UTI antibiotics in an average of 5.85 hours, matching standard lab accuracy in a University of Reading study published in the Journal of Antimicrobial Chemotherapy.