Category: Diagnostic Technologies

Diagnostic Technologies

Siemens Healthineers Launches FDA-Cleared D-Dimer Blood Test

Siemens Healthineers has launched the FDA-cleared Innovance D-Dimer 2.0 assay, designed for rapid exclusion of DVT and PE in outpatients and optimized for STAT laboratory testing.

Diagnostic Technologies

Leica Biosystems Adds Tempus Oncology AI Tools to Aperio AI Store

Leica Biosystems has added Tempus’ Paige PanCancer Detect and Paige Prostate AI tools to the Aperio AI Store, expanding integrated digital pathology solutions for oncology research within the Aperio HALO AP platform.

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

Leica Biosystems Launches Laser Cassette Printer for Histology Labs

Leica Biosystems has launched the HistoCore LIGHTNING C Laser Cassette Printer, a UV laser system that prints barcodes in as little as 2.5 seconds per cassette, aiming to streamline histology workflows and improve specimen traceability.

Digital Pathology

Source BioScience Selects Sectra to Connect NHS Trusts with External Specialist Pathologists

Source BioScience has signed a three-year agreement with Sectra to use its Image Exchange Portal, aiming to digitally route up to 60,000 NHS pathology cases to external specialist pathologists in the first year.

Clinical Chemistry

Quest Diagnostics to Integrate 50-Biomarker Test Panel into Apple Health App

Quest Diagnostics will integrate a 50-biomarker lab test panel into the Apple Health app, allowing US users to order preventive testing and access clinical results on iPhone and iPad.

Flow Cytometry

Waters Launches Spectral Flow Cytometry Analyzer for High-Parameter Research

Waters has launched the BD FACSDiscover A7 Cell Analyzer, a spectral flow cytometer with up to five lasers and 78 detectors, enabling analysis of over 50 single-cell characteristics with less than 10% variation, according to the company.

Hematology & Serology

MolDX Proposes Medicare Coverage for Optical Genome Mapping in Hematologic Neoplasms

MolDX has proposed a draft Local Coverage Determination to establish Medicare coverage criteria for optical genome mapping in hematologic neoplasms, with public comment open through Oct. 11, 2026, according to Bionano Laboratories.

Immunoassay

Combining p-tau217 Blood Tests with APOE4 Genotyping Forecasts Alzheimer’s Symptom Onset, Study Finds

A Columbia University study finds that combining plasma p-tau217 blood tests with APOE4 genotyping can predict Alzheimer’s symptom onset within three to four years in high-risk, asymptomatic individuals.

Mass Spectrometry

Pillar Biosciences and Hamilton Launch Automated NGS Library Prep for 21-Gene Panel

Pillar Biosciences and Hamilton Company have launched an automated NGS library prep method for the oncoReveal Nexus 21 Gene Panel, validated for use on Hamilton’s Microlab STAR and STARlet liquid handling systems.

Microbiology

FDA Grants Breakthrough Device Designation to Same-Day Urine ID/AST Test

The FDA has granted Breakthrough Device Designation to Pattern Bioscience’s Urine ID/AST Panel, a same-day assay for pathogen ID and antimicrobial susceptibility directly from uncultured urine specimens.

Molecular Diagnostics

OGT Expands NGS Indexing Capacity to 384 Samples Per Run

OGT has expanded its SureSeq Universal NGS Unique Dual Index portfolio, enabling up to 384 uniquely indexed samples per run on Illumina platforms, quadrupling previous capacity and supporting higher-throughput workflows, according to the company.

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

Beckman Coulter Launches DxU 1800 Automated Urinalysis System to Streamline Lab Workflows

The automated urinalysis system integrates chemistry and microscopy to help labs manage higher testing volumes and reduce manual reviews to under 3%, according to the company.