FDA Grants Breakthrough Device Designation to Cleo Skin AI Pathology Tool
Clinical studies found improved melanoma detection sensitivity, while a small US evaluation showed a 20% reduction in slide analysis time.
Clinical studies found improved melanoma detection sensitivity, while a small US evaluation showed a 20% reduction in slide analysis time.
Toumy Guettouche, PhD, chief scientific officer at Mercy BioAnalytics and a study co-author, discusses how a blood test measuring proteins on extracellular vesicles detected signs of early-stage ovarian cancer before diagnosis—and what researchers still need to establish before the approach could be used for routine screening.
Thermo Fisher Scientific has introduced value-priced AmpSure Universal SYBR Green and Probe Master Mixes, designed for compatibility with existing qPCR instruments and workflows, according to the company.
The kit allows laboratories to extract DNA and RNA from a range of clinical specimens using a single method.
The research-use-only assay combines two key genetic markers for acute myeloid leukemia in a single test, potentially reducing the need for separate testing workflows and reference lab send-outs.