Category: Diagnostic Technologies

Diagnostic Technologies

AMDI Submits FDA Application for 10-Minute Respiratory PCR Test

The Fast PCR Mini Respiratory Panel simultaneously detects Flu A, Flu B, RSV, and SARS-CoV-2 from nasal swab specimens.

Diagnostic Technologies

Barrett’s Esophagus Test Identifies High-Risk Patients Missed by Standard Pathology

A study of 85 patients shows the TissueCypher test detected 15% with elevated cancer progression risk despite a non-dysplastic diagnosis.

Panome Bio Launches Commercial Metabolomics Workflow for FFPE Samples
Sophia Genetics Partners with Belgian Hospital to Streamline Next-Generation Sequencing Workflows
Roche Gains CE IVDR Approval for Expanded HER2 Companion Diagnostic
Teal Health Expands At-Home Cervical Cancer Screening to New York and Florida
Mass General Brigham Launches Genetic Test for Eight Cardiovascular Conditions
Foresight Diagnostics Reports Clinical Performance Data for ctDNA Assay in Early-Stage Lung Cancer

Diagnostic Technologies

The Diagnostic Revolution That Could Finally Deliver on the Promise of Precision Medicine—And Why Medical Training Must Catch Up

Despite powerful advances in precision medicine, most doctors remain untrained in these emerging diagnostic tools.

Anatomic Pathology

Study Supports Exclusion of Cervical Serous Carcinoma from WHO Classification

High-grade serous carcinoma identified in cervical biopsies is overwhelmingly secondary to upper genital tract tumors, most commonly of endometrial origin, the study finds.

Digital Pathology

AI Platform Aims to Streamline Clinical Trial Matching at Diagnosis

The new platform automatically identifies clinical trial candidates at diagnosis, leveraging network expected to process 8 million pathology cases annually.

Clinical Chemistry

BioPorto’s Acute Kidney Injury Test Now Available to US Labs Through Roche Partnership

The collaboration marks the first major commercial step to advance adoption of ProNephro AKI across US hospital institutions.

Flow Cytometry

Thermo Fisher Scientific Launches Next-Generation Spectral Flow Cytometry Beads

The beads offer multispecies compatibility and cell-like performance to reduce false positives in flow cytometry analysis.

Hematology & Serology

CoaguSense System Approved in Europe for Self-Monitoring of Oral Anticoagulation Therapy

The Coag-Sense PT/INR Monitoring System gains IVDR approval for home anticoagulation monitoring, marking the company's European market entry.

Immunoassay

Lateral Flow Assays Market Projected to Reach $12.1 Billion by 2030

Market growth driven by expanding clinical applications and regulatory innovation, with kits and reagents dominating product segments.

Mass Spectrometry

Oxford Instruments Launches 90 MHz Benchtop NMR Spectrometer

The X-Pulse 90 is designed to deliver enhanced sensitivity and faster data collection.

Microbiology

New Multiplex Assay Panel Detects Urinary Pathogens and Antibiotic Resistance Genes

Research-use-only assay identifies 28 urinary targets and 25 antibiotic resistance markers with same-day turnaround time.

Molecular Diagnostics

Quest Diagnostics Launches Pharmacogenomics Testing Service for Medication Guidance

New offering combines genetic testing with clinical decision support tools to help optimize medication selection and dosing across multiple specialties.

Point-of-Care

UAE Approves Biomerica’s Home Kidney Test

The test detects early albumin markers in urine within 10 minutes, targeting high-risk diabetes and hypertension patients.

Urinalysis & Toxicology

Fentanyl Positivity Rates Seven Times Higher in Random vs Pre-Employment Drug Tests

The sharp increase in fentanyl in random drug checks suggests more workers are using the opioid after they have passed pre-employment screens.