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.
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.
Urinalysis comparison guide featuring testing capabilities, technology, throughput, connectivity, sample capacity, and key specifications from leading systems.
Hamamatsu Photonics received FDA 510(k) clearance for its NanoZoomer S20MD and S540MD slide scanner systems, expanding digital pathology options for clinical labs to include compact benchtop and high-throughput workflows.
AI models analyzing routine H&E slides can identify genomic alterations and immune patterns in NSCLC, supporting biomarker discovery and patient stratification, according to studies to be presented by Lunit at WCLC 2026.
Humanity Health and Quest Diagnostics have launched a biological age analysis add-on for select health profile tests in the US, allowing users to assess aging biomarkers using routine blood samples.
Hematogenix’s next-generation flow cytometry assay was used as the pivotal efficacy measure supporting FDA accelerated approval of ZENBEXUS, the first CELMoD therapy for multiple myeloma.
Precision BioLogic reports rising demand for its chromogenic factor VIII assay as labs prepare for new hemophilia A therapies, including bispecific antibodies submitted for FDA review by Novo Nordisk.
Health Canada has approved Fujirebio’s Lumipulse G NfL Blood and pTau 217 Plasma assays, expanding access to blood-based neurology biomarkers for clinical use on the Lumipulse G immunoassay platform.
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.
Yourgene Health has launched its IVDR-certified DPYD assay in Europe, enabling detection of 19 DPYD gene variants to help clinical labs identify cancer patients at risk of severe toxicity from fluoropyrimidine chemotherapy.
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.