Category: Diagnostic Technologies

Diagnostic Technologies

Senator Honored for Efforts to Improve Pediatric Lab Testing

The ADLM honored senator Shelley Moore Capito for advancing pediatric reference intervals, citing her support for related provisions in Senate appropriations bills for FY 2025 and 2026.

Diagnostic Technologies

Tempus Launches Open-Source Digital Pathology Consortium with Major Medical Centers

The initiative aims to standardize digital pathology through an open-source platform and image management system.

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

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.

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

Multi-Cancer Blood Test Reduces Stage IV Diagnoses in Large Clinical Trial

Results from the NHS-Galleri study show a 26% reduction in metastatic cancer diagnoses by the third round of screening.

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

Urine Metabolite Test Shows Potential for Autism Risk Screening

The screening tool identifies specific molecules produced by gut bacteria to distinguish children with autism from typically developing peers.