Abstract: A method and kit is provided to quantifying and qualifying exosomes in human cell derived samples or in body fluid based on expression of TM9-superfamily proteins on the exosomes. Furthermore, a method and a kit to diagnose malignant tumors is provided. The disclosure also provides a method to monitor tumor growth.

Abstract: This disclosure provides a method to capture, detect, characterize and quantify human exosomes in small volumes of human body fluids by using a sandwich ELISA test. This method allows a full characterization of an exosome preparation, thus providing a tool to distinguish a disease-related condition from a healthy state, by the use of a non-invasive assay. In fact, this method may be useful in screening, diagnosis and prognosis of tumors, with a simple plasma sample. At the same time measurement of circulating exosomes may provide information on the level of tumor mass present in a patient. The method provided here is suitable to evaluate presence of some infectious and/or transmissible agents, such as viral proteins or prion proteins, within circulating exosomes.

Abstract: A method and a kit are provided to quantify and qualify exosomes. Specifically the method and the kit quantify PSA-carrying exosomes for a purpose to diagnose prostate cancer and to distinguish between patients having a tumor and those having a benign prostate condition with increased blood levels of PSA. The method and the kit provide a fast, easy to use and accurate method for clinical settings.

Abstract: The present invention provides monoclonal antibodies to TM9SF-proteins and hybridoma cell lines that produce the monoclonal antibodies to TM9SF4. This invention also provides a method for determining the level of TM9SF4-protein in biological fluid samples, tissue samples and in microvesicles such as exosomes, comprising kit for determining the level of TM9SF4 protein in human exosomes and other microvesicles, in tissue samples, and in biological fluids.

Abstract: A method and kit is provided to quantifying and qualifying exosomes in human cell derived samples or in body fluid based on expression of TM9-superfamily proteins on the exosomes. Furthermore, a method and a kit to diagnose malignant tumors is provided. The disclosure also provides a method to monitor tumor growth.

Abstract: This disclosure characterizes the function and the expression of the human protein encoded by tm9sf4. The protein is highly expressed in malignant tumor cells and therefore is a novel marker for malignancy. Moreover, the protein is involved in the phagocytotic character of tumor cells. This disclosure provides methods and tools to diagnose and follow up malignancy of tumors. Furthermore, means to inhibit phagocytotic character of tumor cells as well as means to treat cancer are provided.

Abstract: This disclosure provides a method to capture, detect, characterize and quantify human exosomes in small volumes of human body fluids by using a sandwich ELISA test. This method allows a full characterization of an exosome preparation, thus providing a tool to distinguish a disease-related condition from a healthy state, by the use of a non-invasive assay. In fact, this method may be useful in screening, diagnosis and prognosis of tumors, with a simple plasma sample. At the same time measurement of circulating exosomes may provide information on the level of tumor mass present in a patient. The method provided here is suitable to evaluate presence of some infectious and/or transmissible agents, such as viral proteins or prion proteins, within circulating exosomes.

Abstract: This disclosure characterizes the function and the expression of the human protein encoded by tm9sf4. The protein is highly expressed in malignant tumor cells and therefore is a novel marker for malignancy. Moreover, the protein is involved in the phagocytotic character of tumor cells. This disclosure provides methods and tools to diagnose and follow up malignancy of tumors. Furthermore, means to inhibit phagocytotic character of tumor cells as well as means to treat cancer are provided.