Category: Diagnostic Technologies

Diagnostic Technologies

Biotia Launches Antimicrobial Resistance Test for Complicated UTIs

The technology provides rapid resistance profiling for recurrent or complicated infections and is approved for use in all 50 US states.

Diagnostic Technologies

FDA Grants Breakthrough Designation to Urine-Based Alzheimer’s Test

The test uses urinary volatile organic compound patterns and machine learning to aid in the diagnosis of Alzheimer’s disease.

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

USC and Hamamatsu Photonics Partner to Improve Pathology Lab Workflows

The Keck School of Medicine of USC and Hamamatsu Corp have partnered to deploy NanoZoomer slide scanners, studying digital pathology workflow improvements in real-world lab environments to enhance efficiency and patient outcomes.

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

FDA Approves Guardant Health’s New Blood-Based Cancer Test for Advanced Tumors

The FDA has approved Guardant360 Liquid CDx, a blood-based test that integrates genomic and epigenomic profiling for advanced cancer, offering a broader genomic footprint and faster results.

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.