The FDA has cleared Qiagen’s QIAstat-Dx BCID GN Plus AMR Panel, enabling U.S. labs to detect 13 gram-negative bacterial pathogens and 18 resistance markers in about one hour on the QIAstat-Dx system.
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.
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.
Mayo Clinic researchers report that AI-enabled spatial analysis of standard pathology slides can predict pancreatic cancer recurrence risk more accurately than volume-based methods, according to a study in Clinical Cancer Research.
The rollout links more than 350 pathology experts across 12 countries to support routine case review and AI diagnostic integration.
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.
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.
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.
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.
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.
Astorg has completed its acquisition of Thermo Fisher’s global microbiology business, establishing an independent diagnostics company. Dirk Bontridder has been named CEO.
Fuse Diagnostics has raised £1 million to commercialize its instrument-free Flip molecular testing platform and expand manufacturing in Cambridge, UK, according to a company press release.
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.