Diasorin has received FDA 510(k) clearance for its customizable LIAISON PLEX Gastrointestinal Flex Assay, allowing labs to select from 24 targets to tailor testing based on patient needs and operational priorities.
The FDA has cleared Datar Cancer Genetics’ CellDx-Tissue, a genomic profiling assay that analyzes 517 cancer-associated genes from solid tumor tissue to support clinical decision-making, according to the company.
Laboratories are leveraging established diagnostic and surveillance tools to track the Andes hantavirus outbreak linked to a cruise ship, with experts noting no evidence of widespread community transmission or efficient airborne spread.
HistoIndex has partnered with Houston Research Institute and Knowledge Research Center to expand access to AI-driven digital pathology for liver disease diagnostics in Texas and California.
The FDA has cleared ArteraAI Breast, an AI-based digital pathology tool that provides same-day risk stratification for early-stage, HR-positive, HER2-negative invasive breast cancer.
Researchers at Mass General Brigham identified 16 routine lab markers, including cholesterol and glucose, linked to PTSD’s physical effects, suggesting standard tests could aid in assessing the disorder’s multi-organ impact.
Bio-Rad has expanded its TrailBlazer StarBright Dye Label Kits to 32 options, now available in Europe for flow cytometry and fluorescent western blot applications, according to the company.
The test allows for simultaneous detection of multiple viruses on a sample-to-answer platform designed for immunocompromised patients.
The certification verifies that the automated immunoassay provides results equivalent to the gold standard method for measuring total testosterone.
AOA Dx presented data at AACR 2026 supporting its AKRIVIS GD Test System, a multi-omic, blood-based assay for early ovarian cancer detection in symptomatic women, reporting an AUC of 0.92 in clinical controls.
New research indicates that standard and modified two-tiered testing algorithms fail to detect infection in up to 78% of patients during the early stages of the disease.
Foundation Medicine and Bristol Myers Squibb have expanded their partnership to develop an NGS-based companion diagnostic for identifying homozygous MTAP deletions, supporting targeted therapy development in precision oncology.
The cobas liat system delivers PCR results in 15 minutes, detecting and differentiating between three Bordetella pathogens including whooping cough.
A rapid urine test identified effective UTI antibiotics in an average of 5.85 hours, matching standard lab accuracy in a University of Reading study published in the Journal of Antimicrobial Chemotherapy.