The invention relates to a peptidomimetic of an NPC-1 epitope on the MUC5AC protein which is differentially expressed in pancreatic and colorectal cancer, and diagnostic and therapeutic usages. Further, antibodies that selectively bind the NPC-1 epitope peptidomimetics and may be used in diagnostic and therapeutic methods.

Provided is a biomarker for detecting colorectal cancer in an early stage. A colorectal cancer biomarker for detecting colorectal cancer, wherein the biomarker consists of at least one protein of the following 22 proteins with numbers 1 to 22, or at least one peptide of the partial peptides of the proteins with numbers 1 to 22: 1. Annexin A11; 2. Annexin A3; 3. Annexin A4; 4. Tanascin-N; 5. Transferrin receptor protein 1; 6. Glucose transporter 1; 7. Complement component C9; 8. CD88 antigen; 9. 78 kDa glucose-regulated protein; 10. -1-acid glycoprotein; 11. Matrix metalloproteinase-9; 12. Angiopoietin-1; 13. CD67 antigen; 14. Mucin-5B; 15. Adapter protein GRB2; 16. Annexin A5; 17. Olfactomedin-4; 18. Neutral amino acid transporter B(0); 19. Tripeptidyl-peptidase 1; 20. Heat shock-related 70 kDa protein 2; 21. Proteasome subunit type-5; or 22. Neutrophil gelatinase-associated lipocalin.

In various embodiments the invention provides anti-mucin-like protein (MLP) monoclonal antibodies, compositions and methods for detecting MLP as a biomarker for mucin-secreting type of cancer such as ovarian or pancreatic cancer.

The invention concerns methods employing antibodies directed against the signal peptide (SP) domain of various disease-associated polypeptides. These anti SP antibodies are capable of detecting cell surface expression of these SP domains and therefore they can be used in methods of diagnosis and/or therapy. In one aspect, the invention provides a method for determining the suitability for treatment of a subject suffering from a disease, whereby detection of cell surface expression of a specific SP indicates that the subject would benefit from therapy directed against this SP. The invention is specifically exemplified with antibodies directed against the signal peptide of MUC1 which is expressed on the surface of various cancer cells, and with signal peptide domains of Mycobacterium tuberculosis. In other aspects the invention provides methods for diagnosis of disease based on the detection of endogenously produced anti SP antibodies.

A method for detecting a target cell surface molecule and classifying cell types in a fluid sample. The method involves the addition of a reagent to the fluid sample. The reagent includes nanoparticles with optical plasmonic resonances, and at least one fluorescent probe. The nanoparticles are a bio-optical probe for the target cell surface molecule. Each fluorescent probe targets a cell classification marker. The method further involves the acquisition of an image using dark field microscopy and fluorescence microscopy to detect and quantify the presence or absence of any cells in the fluid sample having the target cell surface molecule or having the cell classification marker.

The present invention relates to methods of diagnosing a liver disorder in a patient, as well as methods of monitoring the progression of a liver disorder and/or methods of monitoring a treatment protocol of a therapeutic agent or a chemotherapeutic regimen. The invention also relates to assay methods used in connection with the diagnostic methods described herein.

The present invention, relates to the use of TFF3 in the diagnosis and detection of Barrett's Oesophagus using non-invasive, non-endoscopic methods.

It is an object to provide a culture method which is capable of maintaining and/or culturing iPS cell-derived intestinal stem cells, while maintaining the properties of intestinal stem cells. The induced pluripotent stem cell-derived intestinal stem cell-like cells are cultured in the presence of a GSK-3 inhibitor, a histone deacetylation inhibitor, and a serum replacement, or in the presence of a GSK-3 inhibitor and a serum replacement. Preferably, the culture is carried out under conditions in which one or more compounds selected from the group consisting of an epidermal growth factor, a TGF receptor inhibitor and a fibroblast growth factor are further present.

The problem to be solved is to provide an anti-human MUC1 antibody Fab fragment that is expected to be useful in the diagnosis and/or treatment of a cancer, particularly, the diagnosis and/or treatment of breast cancer or bladder cancer, and a diagnosis approach and/or a treatment approach using a conjugate comprising the Fab fragment. The solution is an anti-human MUC1 antibody Fab fragment comprising a heavy chain fragment comprising a heavy chain variable region consisting of the amino acid sequence represented by SEQ ID NO: 8 or 10, and a light chain comprising a light chain variable region consisting of the amino acid sequence represented by SEQ ID NO: 12, and a conjugate comprising the Fab fragment.

The problem to be solved is to provide an anti-human MUC1 antibody Fab fragment that is expected to be useful in the diagnosis and/or treatment of a cancer, particularly, the diagnosis and/or treatment of breast cancer or bladder cancer, and a diagnosis approach and/or a treatment approach using a conjugate comprising the Fab fragment. The solution is an anti-human MUC1 antibody Fab fragment comprising a heavy chain fragment comprising a heavy chain variable region consisting of the amino acid sequence represented by SEQ ID NO: 8 or 10, and a light chain comprising a light chain variable region consisting of the amino acid sequence represented by SEQ ID NO: 12, and a conjugate comprising the Fab fragment.