Disclosed herein is a method of diagnosing a malignant glioblastoma. The method can comprise of isolating glioma-derived exosomes from a bodily fluid of the subject, and characterizing the amount of Cluster of Differentiation (CD44) and Cluster of Differentiation 133 (CD133) present in the glioma-derived exosomes. This method allows for the diagnosis of a malignant glioblastoma using CD44 and CD133 levels in EGFRviii specific immunocaptured exosomes from bodily fluids, which has previously not been recognized as providing an indication of a glioblastoma.

Biomarkers and combinations thereof for determining risk and onset of preeclampsia, methods for their use and for diagnosis, prediction of risk, management, and treatment of preeclampsia in pregnant human females are provided.

The present invention is directed to a method for identifying an individual who is at risk for developing metastatic liver disease that involves measuring, in a sample isolated from the individual, exosomal levels of one or more markers of metastatic liver disease. Kits for carrying out this method are also disclosed. The present invention also relates to a method of preventing metastatic liver disease in an individual who are at risk for developing the disease that involves administering one or more inhibitors of liver premetastatic niche formation.

Methods for treating tumors by administering ionizing radiation and an immune modulator to a patient with cancer are disclosed. The methods provide the dual benefits of anti-tumor efficacy plus normal tissue protection when combining immune modulators with ionizing radiation to treat cancer patients. The methods described herein also allow for the classification of patients into groups for receiving optimized radiation treatment in combination with an immune modulator based on patient-specific biomarker signatures.

The invention relates to methods and pharmaceutical compositions for the treatment of Cytokine Release Syndrome (CRS). The invention also relates to methods for the diagnosis of patients suffering from Cytokine Release Syndrome. The inventors investigate iron homeostasis and the role of CD44-mediated iron endocytosis in the severe inflammatory response and Cytokine Release Syndrome, particularly in SARS-CoV-2 patients. The inventors demonstrate that during activation of M1 macrophages, iron endocytosis is upregulated in a CD44-dependent manner and that CD44 protein levels increase. This effect is specific to M1 macrophages, whereas levels of the canonical iron endocytosis protein TfR1/CD71 remain unchanged. In the present invention, the inventors provide in vitro evidences towards a direct role of CD44-mediated iron endocytosis in the severe inflammatory response such as Cytokine Release Syndrome observed in SARS-CoV-2 patients. Thus, the present invention relates to an antagonist of CD44/Hyaluronic Acid pathway for use in the treatment of cytokine release syndrome in a subject in need thereof, particularly severe COVID-19-related cytokine release syndrome.

The present disclosure relates to a method of prognosing and predicting breast cancer recurrence in patients, More particularly, the present disclosure relates to a method of prognosing which stratifies early stage ER+/PR+ and Her2− breast cancer patients with invasive ductal/lobular carcinoma of the breast into low risk or high risk for breast cancer recurrence by employing an IHC based assay which assesses or measures expression of a combination of 5 biomarkers and by employing a histopathological analysis which assesses 3 clinical prognostic parameters. The present disclosure also relates to a combination of 5 biological markers and 3 clinical prognostics markers employed in the method for prognosis of breast cancer, a kit/test comprising the antibodies against said markers for said prognosis and an IHC based assay system comprising said markers.

The invention provides methods and compositions for detecting non-hematopoietic, non-tumor EphA3-expressing cells in cancer patients and for monitoring the prognosis of patients using EphA3.

Means that enables monitoring of an anticancer effect of an anti-CD4 antibody or an anticancer drug targeting an immune checkpoint is disclosed. The method for testing a therapeutic effect of a cancer therapy of the present invention is a method for testing a therapeutic effect of an anticancer drug comprising as an effective ingredient an anti-CD4 antibody or an anticancer drug targeting an immune checkpoint, which method comprises investigation of expression of (1) at least one immune checkpoint receptor, (2) CD8, and (3) at least one cell surface molecule selected from the group consisting of CD44 and CD45RO, on T cells using a sample derived from a patient who received the anticancer drug. Induction of a T cell population which is positive for the immune checkpoint molecule (1) and positive for CD8, and which shows high expression of CD44 and/or high expression of CD45RO, indicates that said anticancer drug is producing a therapeutic effect in said patient.

The present invention generally relates to methods, assays, compositions and kits related to a subpopulation of ovarian cancer stem cells which are selected or enriched by chemotherapeutic agents and inhibited by MIS (Mullerian Inhibiting Substance) and MIS mimetics. In particular, the present invention relates to a population of CD44+/CD24+/EpCam+/ECad− subpopulation of ovarian cancer stem cells. The present invention also provides methods to screen a subject with ovarian cancer to identify if they have an ovarian cancer comprising CD44+/CD24+/EpCam+/ECad− ovarian cancer stem cells, and methods to identify and enrich or isolate for such ovarian cancer cell populations.

The present invention relates to biomarkers associated with immune-mediated inflammatory disease (IMID), particular GLX molecules, and even more particular GLX-related glycosaminglycans (GAGs) and GLX-related proteoglycans (PGs).