The FDA has expanded approval of Roche’s PATHWAY HER2 and VENTANA HER2 tests to identify HER2-positive metastatic gastroesophageal adenocarcinoma, aiding selection of patients for HER2-targeted therapy.
Researchers at the University of Toledo have developed a rapid blood assay that detects elevated bile acids—an early marker of liver disease—by measuring red blood cell membrane rigidity.
Proscia’s Concentriq AP-Dx digital pathology platform has received FDA 510(k) clearance for compatibility with the Leica Aperio GT 450 DX scanner and a Predetermined Change Control Plan to streamline future updates.
The company says its US business combines automated kit manufacturing, fulfillment, sample logistics, and digital workflow technology into a single diagnostic testing platform.
Leica Biosystems received FDA 510(k) clearances for AI-assisted quality control software and two digital pathology scanners, including the first standalone tool to automate QC for digital slides in clinical workflows.
Researchers have launched LipidLibrarian, an open-source tool that integrates data from major lipid databases to streamline diagnostic marker identification.
The assay is designed to detect minimal residual disease with greater sensitivity than conventional flow cytometry.
The company showcased its latest automation and informatics platforms designed to improve laboratory efficiency and diagnostic accuracy.
Case Western Reserve University and Hemex Health are developing a rapid, noninvasive chairside oral cancer test, supported by a $2.93 million NIH grant, aiming to reduce unnecessary biopsies and enable point-of-care diagnostics.
SCIEX has launched the ExionLC MD system and updated SCIEX OS software, featuring workflow automation and high-performance UHPLC, to help clinical labs improve productivity, as announced at the ADLM meeting.
Astorg has completed its acquisition of Thermo Fisher’s global microbiology business, establishing an independent diagnostics company. Dirk Bontridder has been named CEO.
Zepto Life Technology received up to $8.9 million from NIAID to develop a plasma cell-free DNA liquid biopsy platform aimed at improving diagnosis of invasive fungal infections.
The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.
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.