Category: Diagnostic Technologies

Diagnostic Technologies

FDA Grants Breakthrough Device Designation to Cleo Skin AI Pathology Tool

Clinical studies found improved melanoma detection sensitivity, while a small US evaluation showed a 20% reduction in slide analysis time.

Diagnostic Technologies

Study Finds High Success Rate for Nonendoscopic Esophageal Precancer Testing

A real-world analysis of nearly 12,000 patients found that esophageal cell collection was successful in 95% of cases, with procedures taking less than two minutes on average.

Diagnostic Technologies

Broader Screening Criteria Double Positive Results for Primary Aldosteronism, Study Finds

A study of 60,449 lab results found that using broader screening thresholds doubled detection rates of primary aldosteronism compared to Endocrine Society guidelines, according to research in Hypertension.

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

Blood Test Using 10 Biomarkers May Help Predict Chronic Disease Risk

Researchers developed a simplified metabolic health score using routine blood markers to identify people at greater risk of developing cardiometabolic disease.

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

Instrumentation Laboratories Removes HIT Antibody Test Over False-Negative Risk

The FDA has classified the recall of four affected lots as the most serious type after performance issues were identified that routine quality control may not detect.

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.