Category: Diagnostic Technologies

Diagnostic Technologies

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.

Diagnostic Technologies

Foundation Medicine Expands Bristol Myers Squibb Deal to Develop MTAP Biomarker Test

Foundation Medicine and Bristol Myers Squibb have expanded their partnership to develop an NGS-based companion diagnostic for identifying homozygous MTAP deletions, supporting targeted therapy development in precision oncology.

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

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.

Molecular Diagnostics

A Urine Test That Could Help Predict Bladder Cancer Recurrence

Researchers have developed a urine-based liquid biopsy test that filters age-related mutations, potentially enabling more accurate prediction of bladder cancer recurrence and guiding immunotherapy decisions.

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.