Category: Diagnostic Technologies

Diagnostic Technologies

MIT Engineers Develop Handheld Device to Collect Viable Cells for Early Cancer Detection

Using microfluidic shear stress, the system detaches living cells from excised tissue to support pathology workflows and downstream diagnostic testing.

Diagnostic Technologies

Coffee Mug Powers Portable Test for Seven Mosquito-Borne Viruses

University of Florida researchers have developed a portable diagnostic device that detects and differentiates seven mosquito-borne viruses in under an hour, offering rapid results without the need for traditional lab equipment.

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

Deciphex Launches CipherX Pathology AI Engine With Auditable Semantic Layer

Deciphex has launched CipherX, an AI engine for histopathology workflows that offers an auditable semantic layer; detection algorithms show up to 99.85% negative predictive value in routine casework.

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

Werfen Gains US FDA Clearance and CE Mark for Aptiva APS IgA Reagent

Werfen has received FDA 510(k) clearance and CE mark for its Aptiva APS IgA reagent, completing its antiphospholipid syndrome testing portfolio for IgA, IgG, and IgM on the Aptiva automated multi-analyte platform.

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 Clears PhAST Phenotypic AST Panel for Positive Blood Cultures

The FDA has cleared PhAST Corp’s PhAST BC GN Panel, an automated phenotypic AST system that delivers antimicrobial susceptibility results from positive blood cultures in as little as 99 minutes.

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

Tampa General Adopts Host-Response Test After Study Shows 33% Drop in Cefepime Use

Tampa General Hospital is the first in the Southeast to implement the MeMed BV host-response test in its emergency workflow, reporting a 33% reduction in cefepime use and 13% fewer hospitalizations, according to hospital-led research.

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.