Category: Diagnostic Technologies

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

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%.

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

HistoIndex Expands AI Liver Disease Diagnostic Access in Texas and California

HistoIndex has partnered with Houston Research Institute and Knowledge Research Center to expand access to AI-driven digital pathology for liver disease diagnostics in Texas and California.

Digital Pathology

Alzheimer’s Blood-Based Biomarker Testing Integrated into Clinical Workflows

Lucent Diagnostics and Tempus AI have partnered to integrate blood-based Alzheimer’s biomarker testing into clinical workflows, aiming to expand access and improve detection accuracy for neurologists.

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

Automated Cytomegalovirus PCR Assay Receives IVDR Certification for Transplant Care

The test allows for simultaneous detection of multiple viruses on a sample-to-answer platform designed for immunocompromised patients.

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

Caris Life Sciences Seeks New York State Authorization for Blood-Based Cancer Test

Caris Life Sciences has applied to the New York State Department of Health for authorization of Caris Assure, a blood-based molecular profiling test for cancer using whole exome and transcriptome sequencing of 22,000 genes.

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.