Category: Diagnostic Technologies

Diagnostic Technologies

FDA Clears Point-of-Care Vaginitis PCR Panel with CLIA Waiver

The 20-minute multiplex test delivers eight results covering bacterial vaginosis, Candida species, and trichomoniasis from clinician- or self-collected swabs.

Biodesix Advances Tumor-Informed and Tumor-Naïve MRD Assays
Hologic and Inpeco Partner to Connect Panther Systems with FlexLab X Automation in Europe
Broader Screening Criteria Double Positive Results for Primary Aldosteronism, Study Finds
Illumina Adds AI-Driven Workflow and Variant Prioritization Tools to BioInsight Platform
Gene by Gene Partners with Children’s Mercy to Sequence Nearly 100,000 Genomes for Pediatric Rare Disease Study
Guardant Health to Highlight Advances in Liquid Biopsy for Cancer Monitoring at ESMO 2026
WHO Grants Emergency Use Listing for Rapid Test Detecting Ebola and 15 Other Pathogens
AI Analysis of Pathology Slides Shows Promise for Guiding Lung Cancer Biomarker Testing
Ultima Genomics Sequencing Platform Selected for 80,000-Sample UK Biobank Study

Diagnostic Technologies

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.

Diagnostic Technologies

Siemens Healthineers Launches CN-3000 and CN-6000 Hemostasis Analyzers in US

Siemens Healthineers has introduced the CN-3000 and CN-6000 hemostasis analyzers in the US, offering integrated testing methodologies and up to 13 hours of walkaway time for mid- and high-volume clinical laboratories.

Anatomic Pathology

TissueCypher Identifies Risk of Barrett’s Esophagus Progression Beyond Biopsy Alone

Castle Biosciences’ new data presented at ACG 2026 show the TissueCypher test offers objective risk stratification for Barrett’s esophagus progression, providing information beyond standard histopathology.

Digital Pathology

Fujifilm Introduces Synapse Pathology v3.0 with Expanded AI Capabilities

The software update adds more than 50 features, an automated AI orchestration hub, and a research-use foundation model for gastrointestinal screening.

Clinical Chemistry

Global Survey Finds Wide Inconsistencies in Bone Biomarker Testing Practices

A global survey of 231 labs in 41 countries, published by IOF and IFCC, reveals significant inconsistencies in bone biomarker testing methods, reference intervals, and quality assessments, highlighting a need for greater harmonization.

Flow Cytometry

Blood Test Differentiates Bacterial and Viral Infections in Febrile Infants

A new blood biomarker ratio using neutrophil CD64 and monocyte CD169 demonstrated 100% sensitivity and 96.6% specificity for distinguishing bacterial from viral infections in febrile infants, according to study data presented at EEMC 2024.

Hematology & Serology

Understanding the Activated Partial Thromboplastin Time in the Modern Coagulation Lab

Variability in APTT assay results remains a challenge due to differences in reagents, activators, and detection systems, according to Sysmex, highlighting the need for lab-specific reference ranges and quality control protocols.

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

University Spin-Out Launches to Commercialize Adrenal Cancer and Hormone Disorder Tests

IMS Solutions, a University of Birmingham and Imperial College London spin-out, has raised £1.1 million to commercialize mass spectrometry-based steroid biomarker tests for adrenal cancer and PMOS, with clinical validation underway.

Microbiology

Researchers Develop Rapid Test for 15 Types of Mycobacteria

UNC and Tulane researchers have developed a CRISPR-based microfluidic assay that identifies 15 nontuberculous mycobacteria species directly from clinical specimens in 3.5 hours, with over 97% sensitivity, according to a recent study.

Molecular Diagnostics

Mayo Clinic Laboratories Invests in Pathology Asia to Expand Regional Genomic Testing

Mayo Clinic Laboratories and Pathology Asia Holdings have announced a strategic investment to expand regional access to molecular and genomic diagnostics in Southeast Asia, Australia, and New Zealand.

Point-of-Care

Ambulance Troponin Testing Helps One-Third of Chest Pain Patients Avoid the ED

Ambulance crews using point-of-care high-sensitivity troponin tests and the HEART score safely avoided ED transport for over one-third of chest pain patients, according to a study presented at the European Emergency Medicine Congress.

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.