Patent ID: 9459260
Filing Date: 2016-10-04
CPC Classification: C07K,G01N

Claim Text:
1. A method of diagnosis or of quantitation of rheumatoid arthritis or fibrosis comprising; obtaining a patient sample comprising blood or a fluid component thereof; conducting an immunoassay to measure fragments of a protein having an N- or C-terminal neo-epitope formed by cleavage of said protein by a protease, said N- or C-terminal neo-epitope comprising at least one citrulline residue, and said fragments being naturally present in said patient sample, and; associating an elevation of said measure in said patient above a normal level with the presence or extent of rheumatoid arthritis or fibrosis, wherein said immunoassay is conducted by a method comprising: contacting the fragments of a protein having an N- or C-terminal neo-epitope comprising at least one citrulline residue that are naturally present in said sample with an isolated antibody or an isolated antibody fragment thereof having specific binding affinity for said fragments of said protein having said N- or C-terminal neo-epitope comprising at least one citrulline residue but not reactive with an intact protein, and measuring the extent of binding of said N- or C-terminal neo-epitope comprising at least one citrulline residue to said antibody or antibody fragment thereof to measure therein fragments having said neo-epitope comprising at least one citrulline residue, wherein said antibody or antibody fragment thereof specifically binds to an N- or C-terminal neo-epitope amino acid sequence formed by cleavage of the intact protein by a protease, said C-terminal neo-epitope amino acid sequence comprising said at least one citrulline residue and having any one of the following sequences: or said N-terminal neo-epitope amino acid sequence comprising said at least one citrulline residue and having any one of the following sequences: