The present invention relates to methods for the prediction of the progression of chronic kidney disease in a patient. More particularly, the invention relates to the early prediction of the fast progression of chronic kidney disease using specific biomarker signatures in urine sample of patients.

The present invention pertains to a new method for the diagnosis, prognosis, stratification and/or monitoring of a therapy, of cancer, preferably colorectal cancer (CRC), in a subject. The method is based on the determination of the level of a panel of least one, preferably 3, 4 and most preferably at least 5, protein biomarker selected from the group consisting of the protein biomarkers Amphiregulin (AREG), Carcinoembryonic antigen (CEA), Insulin like growth factor binding protein 2 (IGFBP2), Keratin, type I cytoskeletal 19 (KRT19), Mannan binding lectin serine protease 1 (MASP1), Osteopontin (OPN), Serum paraoxonase lactonase 3 (PON3) and Transferrin receptor protein 1 (TR), in the biological sample obtained from the subject. The new biomarker panel of the invention allows diagnosing and even stratifying various cancer diseases. Furthermore, provided are diagnostic kits for performing the non-invasive methods of the invention. Since the biomarker panel of the invention provides a statistically robust method independent of the protein detection technology used, and considering that the biomarker panel of the invention is detected in plasma samples of the subjects, the invention provides an early detection screening examination that may be applied to a larger population.

Biomarkers useful for diagnosing and assessing inflammatory disease are provided, along with kits for measuring their expression. The invention also provides predictive models, based on the biomarkers, as well as computer systems, and software embodiments of the models for scoring and optionally classifying samples. The biomarkers include at least two biomarkers selected from the DAIMRK group and the score is a disease activity index (DAI).

The present invention refers to a method of predicting susceptibility of a subject suffering from cancer to a treatment with an anti-cancer drug, wherein the method comprises detecting the presence or absence of a genetic alteration in a long non-coding RNA (IncRNA) that resides in an antisense strand of an oncogene, wherein the genetic alteration disrupts expression of the oncogene, and wherein the subject is predicted to be more susceptible to the treatment if the genetic alteration is present. In particular, the genetic alteration is a silent G>A mutation at Q787Q of the oncogene epidermal growth factor receptor (EGFR). Also disclosed herein is a method of treating a subject suffering from cancer, who was shown to have a genetic alteration in IncRNA that resides in an antisense strand of an oncogene.

The present invention relates to a monoclonal antibody which specifically binds to an EGF2 domain of colon cancer secreted protein-2 (CCSP-2), or an antigen-binding fragment thereof. The monoclonal antibody or the antigen-binding fragment thereof of the present invention specifically binds to the EGF2 domain of CCSP-2, and thus has significantly increased affinity compared with existing peptides specifically binding to CCSP-2 and further increased specificity compared with existing antibodies to CCSP-2. Therefore, in future, accurate diagnosis can be achieved by specific detection of CCSP-2 in the protein level.

Disclosed is a method for predicting whether esophageal cancer is sensitive or resistant to treatment with an ERBB3 inhibitor, e.g, an anti-ERBB3 antibody. Specifically, the method predicts by measurement of expression at the RNA level, or at the protein level, of at least one biomarker selected from SDC2, PTGES, NCF2, NOXA1, CARD6 and GNAZ in a tumor sample.

The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

The invention relates to new identified mutations in the epidermal growth factor receptor gene, leading to amino acidic changes which highly correlate with the resistance to a therapy regimen comprising cetuximab. The invention includes peptide sequences and primers to detect the mutations, as well as kits for predicting the response of a subject to a therapy regime comprising cetuximab. In particular, the invention is useful in the therapy regimen applicable to metastasic colorectal cancer.

The invention relates to methods for predicting the in vivo nephrotoxicity of a drug substance, in particular a nucleic acid molecule such as a siRNA or an antisense oligonucleotide using an in vitro cell based assay measuring the levels of extracellular EGF as toxicity biomarker, potentially in combination with other biomarkers like ATP and KIM-1.

Disclosed are binding agents that include (a) a calcium binding portion which includes an F-helix peptide and a calcium binding loop peptide derived from an EF-hand motif of a calcium binding protein, wherein the C-terminus of the F-helix peptide is covalently linked to the N-terminus of the calcium binding loop peptide by a peptide bond, and (b) a targeting peptide, wherein the N-terminus of the targeting peptide is covalently linked to the C-terminus of the calcium binding portion by a peptide bond. The binding agents can be used for diagnosis and treatment of various disorders.