The application provides polypeptides comprising or essentially consisting of at least one heavy chain variable domain of a heavy chain antibody (V.sub.HH) or a functional fragment thereof, wherein said V.sub.HH or a functional fragment thereof specifically binds to a target protein that is present on and/or specific for a solid tumor, e.g. HER2. The application further provides nucleic acids encoding such polypeptides; methods for preparing such polypeptides; host cells expressing or capable of expressing such polypeptides; compositions, and in particular to pharmaceutical compositions, that comprise such polypeptides, nucleic acids and/or host cells. The application further provides such polypeptides, nucleic acids, host cells and/or compositions, for use in methods for detection, imaging, prognosis and diagnosis of cancer as well as for predicting patient response(s) to therapeutics.

A fluorescent probe includes one or more metal binding functional group, such as phosphonic acid group and an arsonic acid group, in which the functional group is covalently linked to a fluorescent core via a sp.sup.2-carbon atom of the fluorescent core. In embodiments, the fluorescent core is an organic fluorescent compound/moiety, that can be a tetrapyrrole derivative, such as porphyrin or phthalocyanine, acridine, BODIPY, cyanine or cyanine derivatives, carbazole, coumarine or coumarine derivatives, xanthene or xanthene derivatives such as fluorescein or rhodamine. The fluorescent probe can bind to calcium and/or a calcification, such as hydroxyapatite (HAP). In a further aspect, a fluorescent probe is used in a method of detecting calcium, such as a calcification or HAP, in a bodily tissue. The use of the fluorescent probe is also provided for detecting calcium, a calcification and/or HAP, such as calcium depositions in a bodily tissue.

The present invention provides reagents and methods for breast cancer detection.

Provided herein are methods for identifying new biomarkers for various diseases using proteomics, peptidomics, metabolics, proteoglycomics, glycomics, mass spectrometry and machine learning. The present disclosure also provides glycopeptides as biomarkers for various diseases such as cancer and autoimmune diseases.

In one embodiment, an object of the present invention is to provide a biomarker for predicting the prognosis of a cancer patient such as a breast cancer patient. In one embodiment, the present invention relates to use of a CK2α protein or a fragment thereof in a nucleolus as a marker for predicting the prognosis of a cancer patient, a method for predicting the prognosis of a cancer patient using the marker, or a kit comprising a reagent for measuring the marker.

The present invention relates to a composition capable of cancer diagnosis, a diagnostic kit comprising same, and a method for providing information for cancer diagnosis using the composition. When a biomarker of the present invention is used, it is possible to accurately and conveniently diagnose cancer, particularly breast cancer, in an early stage, and furthermore, it is possible to diagnose the stage of cancer and predict therapeutic responsiveness or post-treatment prognosis.

There is disclosed a method for selectively detecting epithelial to mesenchymal transition (EMT) phenotypic cells but not noncancerous/normal epithelial cells and breast fibroblasts in a biological sample or a patient. The compositions comprise novel binding peptides that specifically bind to EMT cancer cells. EMT phenotypic cells can be identified using the specific peptides and quantitatively measured by detection of a complex of the peptide and a detectable marker. Further, nanodevices incorporating specific EMT phage ligand may be used to identify EMT cancer cells in vivo. Also disclosed are the novel binding phage peptides, and compositions and nanodevices containing the phage ligand for carrying out methods of the invention.

A compound of formula (I),

##STR00001##

wherein R.sup.1, R.sup.2, R.sup.3 and R.sup.4 are selected from a saturated or unsaturated, branched or unbranched, cyclic or non-cyclic alkyl, or an amide, or a functional group, or a salt or a solvate thereof, or a protonated form thereof, and to the use thereof for the treatment of cancer.

Heritable mutations in the BRCA1 and BRCA2 and other genes in the DNA double-strand break (DSB) repair pathway increase risk of breast, ovarian and other cancers. In response to DNA breaks, the proteins encoded by these genes bind to each other and are transported into the nucleus to form nuclear foci and initiate homologous recombination. Flow cytometry-based functional variant analyses (FVAs) were developed to determine whether variants in BRCA1 or other DSB repair genes disrupted the binding of BRCA1 to its protein partners, the phosphorylation of p53 or the transport of the BRCA1 complex to the nucleus in response to DNA damage. Each of these assays distinguished high-risk BRCA1 mutations from low-risk BRCA1 controls. Mutations in other DSB repair pathway genes produced molecular phenocopies with these assays. FVA assays may represent an adjunct to sequencing for categorizing VUS or may represent a stand-alone measure for assessing breast cancer risk.

Subject matter of the present invention is a method for predicting the risk of getting cancer in a female subject that does not suffer from cancer or alternatively diagnosing cancer in a female subject comprising: determining the level of Pro-Enkephalin or fragments thereof including Leu-Enkephalin and Met-Enkephalin of at least 5 amino acids in a bodily fluid obtained from said female subject; and correlating said level of Pro-Enkephalin or fragments thereof with a risk for getting cancer, wherein a reduced level is predictive for an enhanced risk of getting cancer or alternatively diagnosing cancer wherein an reduced level is correlated with the diagnosis of cancer.