Extracellular vesicle biomarkers for bladder cancer

A method for early-stage detection of urological cancer from one or more biofluid samples, comprising:

• providing the one or more biofluid samples, wherein the one or more biofluid samples are selected from urine samples, wherein the one or more biofluid samples are from humans with at least one of the following:
• urological cancer, healthy controls, non-cancer urological inflammation, or other relevant conditions;
• selectively and reversibly binding native extracellular vesicles (EV) from the biofluid sample to capture and enrich the EVs of the biofluid sample using Extracellular Vesicles total recovery and purification (EVtrap);
• detecting at least one compound in the biofluid samples, wherein the at least one compound consists of EV proteins and any combination thereof enriched from the biofluid sample resulting in a greater than 95% recovery yield, greater than 99% purity and with less than 5% coefficient of variation of the at least one EV compound;
• generating a panel of detected compounds for the purposes of urological cancer diagnosis, prognosis, detection, monitoring, patient stratification, drug response analysis, and therapy selection;
• analyzing differences in the panel of detected compounds between cancer and non-cancer biofluid samples, including observing that the panel of detected compounds of humans having urological cancer has clear separation from the panel of detected compounds of humans having non-cancer conditions or healthy controls.