Category: Diagnostic Technologies

Diagnostic Technologies

FDA Approves PCR-Based Companion Diagnostic for Keytruda

The assay identifies patients with microsatellite instability-high solid tumors who may be eligible for treatment with the immunotherapy.

Diagnostic Technologies

CAP Examines How Labs Can Get More Diagnostic Information From Smaller Biopsies

A new College of American Pathologists article explores how multiplex immunofluorescence can assess multiple biomarkers in a single tissue section while conserving samples for additional testing.

Diagnostic Technologies

Could a Different Kind of Blood Test Improve Ovarian Cancer Screening?

Toumy Guettouche, PhD, chief scientific officer at Mercy BioAnalytics and a study co-author, discusses how a blood test measuring proteins on extracellular vesicles detected signs of early-stage ovarian cancer before diagnosis—and what researchers still need to establish before the approach could be used for routine screening.

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

Early Blood Test Patterns May Predict Kidney Transplant Outcomes Three Years Later

A study of more than 1,100 transplant recipients found that persistent or later-emerging elevations in donor-derived cell-free DNA were associated with greater risks of rejection and graft loss.

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

Bio-Rad Expands Oncology Assay Menu for QX700 ddPCR Systems

New assays and reagents expand multiplexing capabilities, allowing researchers to analyze more cancer-related mutations and biomarkers in a single reaction.

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.