Category: Diagnostic Technologies

Diagnostic Technologies

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.

Diagnostic Technologies

Fast Sepsis Diagnostics Could Save 36,000 Lives Annually in the US

Early use of rapid sepsis diagnostics could prevent 36,200 deaths and 84,400 sepsis cases annually in the US, according to a multi-country health economic analysis announced by bioMérieux and conducted by the Office of Health Economics.

Diagnostic Technologies

FDA Grants Breakthrough Designation to Breast Cancer Risk Assessment Test

The FDA has granted Breakthrough Device designation to PreludeDx’s AidaBREAST assay, which uses multi-omic data and AI to assess recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.

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

Sapio Sciences Integrates Claude Cowork to Streamline Laboratory Data Management

Sapio Sciences has integrated Anthropic's Claude Cowork AI assistant into its platform, enabling scientists to search, retrieve, and analyze R&D data across ELN and LIMS systems through a single conversational interface.

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

Biotium’s New Cell Barcoding Kit Allows Up to 15-Sample Multiplexing in a Single Flow Cytometry Tube

The ViaPlex 2-Color Cell Barcoding Kit uses two reactive fluorescent dyes to combine up to 15 distinct cell populations in one tube, reducing reagent use and run time.

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

Clinical Trial to Evaluate Finger-Prick Blood Test for Alzheimer’s Diagnosis

The study will analyze three key proteins to determine if blood-based biomarkers can provide an earlier and more accessible diagnostic method.

Mass Spectrometry

Biognosys and Michael J. Fox Foundation Partner to Develop Parkinson’s Disease Biomarkers

The collaboration focuses on creating sensitive assays for a common genetic risk factor to guide drug development and clinical trials.

Microbiology

Astorg to Acquire Thermo Fisher Scientific Microbiology Business

The acquisition will establish the microbiology unit as an independent platform focused on clinical diagnostic consumables and equipment.

Molecular Diagnostics

New Partnership Aims to Improve Early Alzheimer’s Disease Detection

Circular Genomics and Vitazi.ai have formed a partnership to combine AI-driven retinal imaging and blood-based RNA biomarkers for early Alzheimer’s disease detection, aiming to address gaps in early-stage patient identification.

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.