Category: Diagnostic Technologies

Diagnostic Technologies

BIOTYPE and APIS Partner to Commercialize Two Cancer-Related Molecular Tests

The agreement covers an ESR1 mutation detection kit for metastatic breast cancer and a DPYD genotyping kit for assessing chemotherapy toxicity risk.

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.

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

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

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

Ozelle to Showcase AI-Assisted Hematology Analyzer at MEDICA 2026

The O-Cyte 1 combines complete blood count testing, seven-part white blood cell differentials, and digital cell imaging, with configurations supporting up to 360 tests per hour.

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

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.