Category: Diagnostic Technologies

Diagnostic Technologies

Expanded Approval Broadens Use of Roche MMR Test for Immunotherapy Selection

The companion diagnostic evaluates mismatch repair deficiency, a predictive biomarker used to identify patients who may respond to PD-1-targeted therapies.

Diagnostic Technologies

Can an Alzheimer’s Blood Test Detect Early, Subtle Cognitive Decline?

Biomarkers in midlife adults without dementia may be linked to the earliest signs of waning cognition, researchers found.

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

New AI Test Predicts Mortality Risk in Metastatic Prostate Cancer

The digital pathology platform provides patient-specific risk estimates to help clinicians tailor treatment for metastatic hormone-sensitive disease.

Clinical Chemistry

Saliva Test May Identify Acute Sleep Deprivation

Researchers identify molecular markers in saliva that could lead to new clinical tests for sleep loss.

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.