Category: Diagnostic Technologies

Diagnostic Technologies

Leica Biosystems Launches New Digital Pathology Scanner and QC Software

The scanner targets mid-volume labs, while the new software automates slide quality control processes.

Diagnostic Technologies

Meta-Analysis Backs TissueCypher as Strong Predictor of Barrett’s EsophagusProgression

The study consolidating data from six published studies confirms the test outperforms traditional pathology or clinical factors alone in identifying esophageal cancer risk.

Diagnostic Technologies

FDA Proposes Reclassifying Oncology Nucleic Acid–Based Tests from Class III to Class II

The proposed order would shift these test systems to Class II with special controls, replacing the current PMA requirement for companion diagnostics and related oncology assays.

Anatomic Pathology

Mopec Integrates Lumea’s Tissue Handling Technology Into Grossing Station

The integration is designed to bridge specimen grossing with digital pathology workflows for improved diagnostic accuracy and efficiency.

Digital Pathology

Hologic Gains Expanded CE Marking for Digital Pathology System

The Genius Digital Diagnostics System is now approved for both cell and tissue specimen imaging in the European Union.

Clinical Chemistry

Ozelle Unveils AI-Powered Complete Blood Morphology Solution

The all-in-one diagnostic platform combines hematology, biochemistry, and immunoassay testing in a single run.

Flow Cytometry

10x Genomics Launches Next Generation of Chromium Flex to Scale Single-Cell Research

New plate-based multiplexing can profile up to 384 samples and 100 million cells per week.

Hematology & Serology

CMS Increases Reimbursement Rate 47% for Optical Genome Mapping in Blood Cancers

The 2026 clinical lab fee schedule sets payment for CPT code 81195 at $1,853.22, up from $1,263.53 in 2025.

Immunoassay

DPYD Genotyping Assay Receives FDA Breakthrough Device Designation

The qPCR-based test detects variants that increase risk of severe fluoropyrimidine chemotherapy toxicity.

Mass Spectrometry

Thermo Fisher Launches Triple-Quad Mass Spectrometer Aimed at High-Throughput Workflows

The system is designed to handle more than 10,000 injections without cleaning and scan over 900 SRM transitions per second for high-throughput laboratories.

Microbiology

Primerdesign Launches Magnetic Bead Extraction Kit for DNA and RNA

The exsig Mag RapidBead Pro kit features a four-step workflow that reduces extraction time to under 20 minutes.

Molecular Diagnostics

New ‘Ultra-Mild’ Sequencing Method Addresses DNA Methylation Testing Limitations

UMBS-seq preserves DNA integrity while maintaining accuracy for cancer biomarker detection in liquid biopsies and tissue samples.

Point-of-Care

Roche Receives FDA Clearance for Point-of-Care Bordetella Test

The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.

Urinalysis & Toxicology

How Rapid Diagnostics Are Changing Overdose Response in the Synthetic Opioid Crisis

Faster, more accurate testing is helping clinicians identify synthetic opioids sooner and treat overdoses more effectively.