Category: Diagnostic Technologies

Diagnostic Technologies

GeneDx Plans to Add Long-Read Whole Genome Sequencing for Rare Disease Testing

The phenotype-driven testing approach aims to detect structural variants and repeat expansions, with an early access program launching by year-end.

Diagnostic Technologies

AI-Based Blood Test Matches MRE in Identifying MASH Treatment Candidates

In a study of 229 patients, an AI-based liquid biopsy matched magnetic resonance elastography in identifying patients with fibrosis stages associated with eligibility for approved MASH treatments.

Diagnostic Technologies

FDA Clears Rapid Blood Test to Distinguish Bacterial From Viral Infections

The Beckman Coulter assay delivers results in as little as 15 minutes on existing immunoassay analyzers, potentially helping clinicians make faster treatment decisions.

Anatomic Pathology

NeoGenomics Scales AI Digital Pathology Infrastructure with Indica Labs

The expanded partnership deploys the cloud-based HALO AP platform across enterprise laboratories to support emerging biomarker workflows and ADC pipeline diagnostics.

Digital Pathology

Hyland Launches Digital Pathology Platform Integrating Multiple Imaging Specialties

Powered by Tribun Health's CaloPix software, the platform connects pathology with radiology and cardiology imaging systems to support diagnostic workflows and collaboration across healthcare networks.

Clinical Chemistry

Nova Biomedical Corrects Glucose Meters Over Risk of Misassigned Patient Results

Screen retention errors can misassign patient glucose results in electronic records, leading to one reported injury and a planned software update.

Flow Cytometry

Curiox Biosystems Expands Leadership Team to Drive Flow Cytometry Technology Adoption

Curiox Biosystems has expanded its commercial leadership team and established a Strategic Advisory Board to support broader adoption of its centrifuge-free Pluto Workstations for automated flow cytometry sample preparation.

Hematology & Serology

Genetic Testing Reveals Gaps in Sickle Cell and Thalassemia Carrier Documentation

A Mayo Clinic study of nearly 50,000 adults found many carriers of sickle cell and beta-thalassemia traits were not identified in electronic health records, highlighting gaps in current documentation practices.

Immunoassay

China Clears Quanterix and Innovita SIMOA Instruments and Blood-Based Neurology Tests

China’s NMPA has approved Quanterix and Innovita’s HD-X and SR-X immunoassay platforms and four blood-based neurology biomarker tests, expanding access to Alzheimer’s diagnostics in the Chinese clinical lab market.

Mass Spectrometry

Agilent Introduces Faster GC/MS System with Built-In Diagnostics

The new 5987A system is designed to improve laboratory efficiency by identifying potential instrument problems before they disrupt testing.

Microbiology

Rapid PCR Test for UTIs Enters Clinical Use in UK

Genefluence's near-patient test identifies UTI-causing bacteria and antibiotic resistance genes in approximately one hour, potentially helping clinicians make faster treatment decisions.

Molecular Diagnostics

Twist Bioscience Launches Custom MRD Panels for Cancer Assay Development

The new platform offers custom panel manufacturing in as little as one day to support development of tumor-informed MRD assays.

Point-of-Care

Blood Test May Detect Brain Injuries Missed by CT Scans

Researchers identified blood levels of a brain injury biomarker that could help clinicians determine which patients need additional evaluation within 24 hours of trauma.

Urinalysis & Toxicology

Rapid Urine Test Detects 92% of Invasive Aspergillosis Cases in Study

A multicenter study from Johns Hopkins Medicine found that an FDA-cleared rapid urine assay detected 92% of invasive aspergillosis cases, offering results within hours and supporting faster, noninvasive diagnosis in clinical labs.