Abstract: Methods of diagnosis or of quantitation of pathological conditions comprise conducting an immunoassay to measure neo-epitope containing protein fragments naturally present in a biofluid sample, and associating an elevation of the measure in the patient above a normal level with the presence or extent of pathology. The immunoassay is conducted by a method comprising: contacting protein fragments naturally present in the sample with an immunological binding partner reactive with a neo-epitope formed by cleavage of a protein by a proteinase and measuring the extent of binding of peptide fragments to the immunological binding partner to measure therein protein fragments comprising the neo-epitope. Neo-epitopes from, collagen type I, collagen type III, collagen type IV, collagen type V, collagen type VI, elastin, biglycan, decorin, lumican, versican, C-reactive protein, ApoE and laminins are described.

Abstract: Provided herein are methods of diagnosis or of quantitation of fibrosis. An immunoassay is conducted to measure neo-epitope containing protein fragments of collagen type III, collagen type I, collagen type IV, collagen type V, or collagen type VI, elastin, biglycan, decorin, lumican, versican, perlecan, neurocan, brevican, fibromodulin, serglycin, syndecan, betaglycan, vimentin, or C-reactive protein naturally present in a biofluid sample obtained from a patient. An above normal elevation of the measured protein fragments in the patient is associated with the presence or extent of fibrosis.

Abstract: Methods of diagnosis or of quantitation of pathological conditions comprise conducting an immunoassay to measure neo-epitope containing protein fragments naturally present in a biofluid sample, and associating an elevation of said measure in said patient above a normal level with the presence or extent of pathology. The immunoassay is conducted by a method comprising: contacting protein fragments naturally present in said sample with an immunological binding partner reactive with a neo-epitope formed by cleavage of a protein by a proteinase and measuring the extent of binding of peptide fragments to said immunological binding partner to measure therein protein fragments comprising said neo-epitope. Neo-epitopes from, collagen type I, collagen type III, collagen type IV, collagen type V, collagen type VI, elastin, biglycan, decorin, lumican, versican, C-reactive protein, ApoE and laminins are described.

Abstract: A method of immunoassay for fragments of a protein such as type II collagen in a biological sample detects fragments having a first epitope containing an isomerised amino acid residue and a second epitope generated by cleavage of the protein by the use of respective antibodies binding each of the two epitopes.

Abstract: A method of assay measuring in a biological sample fragments of a protein that contain an N-terminal neo-epitope and a C-terminal neo-epitope, each generated by protease cleavage of said protein, comprises binding the N-terminal neo-epitope with a first specific antibody and binding the C-terminal neo-epitope with a second specific antibody, and detecting the extent of dual binding of said antibodies.

Abstract: A method of assay to determine the extent of collagen type II resorption activity comprising measuring the level of fragments of collagen type II that contain a cathepsin K generated neo-epitope not shared by collagen type I by binding the neo-epitope with an antibody specific for the neo-epitope and detecting the level of binding of said binding partner.

Abstract: Methods of diagnosis or of quantitation of fibrosis comprise conducting an immunoassay to measure neo-epitope containing protein fragments naturally present in a biofluid sample, and associating an elevation of said measure in said patient above a normal level with the presence or extent of fibrosis. The immunoassay is conducted by a method comprising: contacting protein fragments naturally present in said sample with an immunological binding partner reactive with a neo-epitope formed by cleavage of a protein by a proteinase and measuring the extent of binding of peptide fragments to said immunological binding partner to measure therein protein fragments comprising said neo-epitope, and wherein said protein is collagen type III, collagen type I, collagen type IV, collagen type V, or collagen type VI, elastin, biglycan, decorin, lumican, versican, perlecan, neurocan, brevican, fibromodulin, serglycin, syndecan, betaglycan, vimentin, or C-reactive protein.