Category: Diagnostic Technologies

Diagnostic Technologies

CirrusDx Adds Lab Testing for Recently Approved UTI Antibiotic

The new capability helps clinicians determine if a patient's infection will respond to gepotidacin before prescribing the treatment.

Diagnostic Technologies

Diazyme Laboratories Acquires Carolina Liquid Chemistries

Diazyme Laboratories has acquired Carolina Liquid Chemistries, integrating CLC’s chemistry systems and reagents with Diazyme’s diagnostic technologies to expand solutions for reference and clinical laboratories.

Diagnostic Technologies

Experts Call for End to Routine ‘Corrected’ Calcium Reporting

A new position statement warns that albumin-adjusted calcium formulas are unreliable and may lead to patient misclassification.

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

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.

Clinical Chemistry

New Biomarker May Improve Diagnosis of Rare Brain and Eye Cancers

The study identifies HAVCR1 as a tool for earlier detection and treatment monitoring for primary central nervous system lymphoma.

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

Sysmex America Launches New Hematology Solution for Clinical Labs

The XR-Series features higher throughput and enhanced analytics to streamline daily laboratory operations.

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

Agilent Launches New Trace Element Analysis System for Laboratories

The new triple quadrupole mass spectrometry system aims to increase sample throughput and simplify interference removal.

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

Thermo Fisher Scientific Launches New DNA and RNA Analysis System

The integrated electrophoresis solution is designed to simplify routine verification by eliminating gel casting and buffer preparation.

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

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.