Category: Diagnostic Technologies

Diagnostic Technologies

Labcorp and Epic Expand Collaboration for Lab Test Ordering

Labcorp’s full test menu is now integrated into Epic’s Aura platform, streamlining lab test ordering and results for health systems and reducing IT complexity.

Diagnostic Technologies

Artera Receives CE Marks for AI-Powered Prostate and Breast Cancer Tests

Artera has received CE marks under EU IVDR for its AI-powered prostate and breast cancer assays, enabling clinical use of these prognostic and predictive tests in the European Union and other territories, the company announced.

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

Researchers Develop Blood Test That May Detect Testicular Cancer Missed by Standard Markers

Mayo Clinic researchers have developed a blood test that detected 93% of germ cell tumors—including cases missed by standard markers.

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

Bruker Launches High-Throughput Molecular Diagnostic System for Infectious Diseases in Europe

Bruker has launched the MyGenius PRO molecular diagnostics system in Europe, offering fully automated, high-throughput PCR testing for infectious diseases with an initial focus on CMV, EBV, and BKV assays for clinical labs.

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.