Tempus AI’s xR RNA sequencing assay has received EU IVDR Class C certification, enabling continued clinical and biopharma access in the EU for gene fusion detection in solid tumors beyond the 2028 regulatory transition deadline.
The new software aims to streamline genomic analysis, help researchers identify disease-related genetic variants, and support studies involving large datasets.
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.
Aignostics has launched HETA Clinical, an AI-based suite for digital pathology that analyzes whole-slide H&E images to assess tumor content and tissue quality, aiming to reduce molecular test failure rates in clinical labs.
New software allows researchers to examine repeat expansions associated with up to 23 disease-related genetic regions in a single run.
A global survey of 231 labs in 41 countries, published by IOF and IFCC, reveals significant inconsistencies in bone biomarker testing methods, reference intervals, and quality assessments, highlighting a need for greater harmonization.
A new blood biomarker ratio using neutrophil CD64 and monocyte CD169 demonstrated 100% sensitivity and 96.6% specificity for distinguishing bacterial from viral infections in febrile infants, according to study data presented at EEMC 2024.
Variability in APTT assay results remains a challenge due to differences in reagents, activators, and detection systems, according to Sysmex, highlighting the need for lab-specific reference ranges and quality control protocols.
China’s NMPA has approved Quanterix and Innovita’s HD-X and SR-X immunoassay platforms and four blood-based neurology biomarker tests, expanding access to Alzheimer’s diagnostics in the Chinese clinical lab market.
IMS Solutions, a University of Birmingham and Imperial College London spin-out, has raised £1.1 million to commercialize mass spectrometry-based steroid biomarker tests for adrenal cancer and PMOS, with clinical validation underway.
UNC and Tulane researchers have developed a CRISPR-based microfluidic assay that identifies 15 nontuberculous mycobacteria species directly from clinical specimens in 3.5 hours, with over 97% sensitivity, according to a recent study.
Delve Bio has launched Delve Detect Plasma, a blood-based mNGS assay capable of detecting over 68,000 pathogens from a single blood draw, with next-day results.
Ambulance crews using point-of-care high-sensitivity troponin tests and the HEART score safely avoided ED transport for over one-third of chest pain patients, according to a study presented at the European Emergency Medicine Congress.
A multicenter study from Johns Hopkins Medicine found that an FDA-cleared rapid urine assay detected 92% of invasive aspergillosis cases, offering results within hours and supporting faster, noninvasive diagnosis in clinical labs.