Nordic Bioscience A/s

Novartis Ag

Efstathios Vassiliadis

Morten A Karsdal

Sanne S Veidal

Diana Julie Leeming

Helene Skjot-Arkil

Antonio Segovia-Silvestre

Natasha Barascuk Michaelsen

Diana Julie Oersnes-Leeming

Natasha Barascuk

Helene Skjøt-Arkil

Diana Julia Leeming

Helene SKJØT-Arkil

A method of bioassay for the quantification of biomarkers useful in the diagnosis of fibrosis disease and prognosis of its development, including biomarkers indicative of the risk of developing fibrosis after a chronic injury is provided. In particular, according to the present invention, biomarkers relating to degradation fragments of Collagen type I, III, IV, V, and VI, elastin, C-reactive protein, and proteoglycans including Biglycan, Decorin, Versican, and Perlecan are found to be useful.

Fibrosis biomarker assay

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.

An immunoassay for the quantification of fragments having an N- or a C-terminal neo-epitope formed by cleavage of a titin protein by a proteinase is provided. The immunoassay includes the steps of contacting a sample with an antibody specifically binding to the N- or C-terminal neo-epitope of the fragments and determining the level of binding.

In vitro assessment of cardiovascular events by assay for neo-eptitopes of titin protein

An assay for citrullinated fragments of SOCS-2, Alpha 1 anti tyrpsin, versican, biglycan, laminin, or other protein having a terminal antibody binding site comprising citrulline in a blood derived sample shows diagnostic relevance in relation to rheumatoid arthritis or fibrotic disease.

Detection of diagnostic peptides

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.

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Rodovre, Denmark

Efstathios Vassiliadis