Methods for diagnosing a subject as a candidate for removal of a solid tumor without preoperative chemoradiation therapy, and methods for treating patients having solid tumors, who have one or more of genomic instability, elevated double stranded DNA breaks, elevated gamma-H2AX foci, or elevated replication stress and/or double stranded break-signalling (DSB-signalling) biomarkers in peripheral blood lymphocytes (PBLs) are provided herein.

Embodiments of the invention describe to methods of diagnosing, classifying, and/or identifying a patient's risk of developing graft versus host disease, including severe or lethal graft versus host disease, after receiving hematopoietic cellular transplantation, a transfusion or a transplantation, but before the onset of clinical symptoms.

The invention is directed to biomarkers for predicting a patient's response, both therapeutic and toxic, to immunotherapy.

Provided are methods of selecting a patient with cancer and/or treating a patient with cancer that comprises a deleterious alteration in FBXW7 and/or an amplification of CCNL1 for CDK11 inhibitor and/or ATR inhibitor treatment. For example, the method of selecting a patient afflicted with a cancer likely to benefit from a CDK11 inhibitor and/or ATR inhibitor treatment, the method comprising: obtaining a biological sample; testing the sample for i) loss of function FBXW7, optionally for a deleterious mutation in F box WD-repeat containing protein (FBXW7) substrate binding domain and/or ii) upregulated CCNL1, optionally a gain or amplification of CCNL1; and selecting the patient having i) loss of function FBXW7, optionally a deleterious mutation in the FBWX7 substrate-binding domain or ii) upregulated CCNL1, optionally a gain or amplification of CCNL1, as likely to benefit and/or for treatment with the CDK11 inhibitor and/or ATR inhibitor.

The present invention provides a method for quantifying a monoclonal (M-) protein in a sample of a subject, the method comprising the steps of:—subjecting a serum sample of a subject to serum protein electrophoresis (SPE) in a gel, preferably serum protein electrophoresis in an agarose gel, to separate serum proteins into different serum protein fractions, optionally followed by immunofixation electrophoresis (IFE) and further optionally involving immunostaining of the gel;—excising from said gel a gel part comprising, or suspected of comprising, a M-protein;—performing an enzymatic digestion of proteins present in said gel part in order to provide a peptide digest comprising at least one M-protein peptide;—subjecting said peptide digest comprising said at least one M-protein peptide to liquid chromatography-mass spectrometry (LC-MS) to determine a quantity of said at least one M-protein peptide, thereby quantifying said M-protein in said sample.

The present invention provides for compounds and methods for the detection and follow-up of Fabry disease (FD). In particular, the present invention relates to a method for detecting or diagnosing FD in a subject, comprising detecting globotriaosylceramide (Gb3) deposits in biomaterial obtained from said subject. The present invention also provides for a method for treatment monitoring of FD in a subject. Further, the present invention relates to the use of a Gb3-specific natural ligand for the detection of Gb3 deposits in biomaterial. Also provided is a kit for detecting Gb3 deposits in biomaterial obtained from a subject.

The present application contemplates methods of screening therapeutic agents for treating cancer comprising co-culturing immune cells and tumor cells isolated from a subject under conditions that allow the immune cells and the tumor cells to form a cancer spheroid. The cancer spheroid may then be exposed to at least one therapeutic agent, and the responsiveness of the tumor cells the spheroid to the therapeutic agent may be measured.

The present invention provides methods for selecting a cancer patient who is AHR nuclear positive, and methods for treating cancer comprising selecting a cancer patient who is AHR nuclear positive, and administering to the patient an AHR inhibitor.

The present disclosure provides methods for predicting and thereby treating cancer or increasing the efficacy of an anti-cancer medication, in part by measuring checkpoint proteins on extracellular vesicles released from non-cancer cells. These checkpoint proteins promote cancer progression and/or compensate for the loss of signal from the checkpoint proteins being inhibited by the checkpoint inhibitory therapy. Compositions and methods of treatment are also provided.

The present invention relates to a companion diagnosis biomarker composition and a companion diagnosis kit containing the same and, particularly, to a companion diagnosis biomarker composition for predicting a therapeutic response to at least one immune checkpoint inhibitor from among a PD-1 immune checkpoint inhibitor and a PD-L1 immune checkpoint inhibitor, and a companion diagnosis kit containing the same. According to the present invention, there is an effect that it is possible to predict a therapeutic response to at least one immune checkpoint inhibitor from among a PD-1 immune checkpoint inhibitor and a PD-L1 immune checkpoint inhibitor not only through a companion diagnosis through cancer patient tissues, but also through proteomic analysis of cancer patient blood.