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Biomarker-guided drug development provides value for patients, payers and drug developers: lessons learned from 25 years in the biomarker industry.

June 1, 2024

Biomarkers

Abstract INTRODUCTION There is an urgent, persistent, need for better biomarkers in clinical drug development. More informative biomarkers can increase the likelihood of drug advancement or approval, and implementing biomarkers increases the success rate in drug development. Biomarkers may guide decisions and allow resources to be directed to the projects most likely to succeed. However, […]

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Serum tau fragments as predictors of death or poor neurological outcome after out-of-hospital cardiac arrest.

September 1, 2019

Biomarkers

Abstract Anoxic brain injury is the primary cause of death after resuscitation from out-of-hospital cardiac arrest (OHCA) and prognostication is challenging. The aim of this study was to evaluate the potential of two fragments of tau as serum biomarkers for neurological outcome. Single-center sub-study of 171 patients included in the Target Temperature Management (TTM) Trial […]

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Association of metabolites reflecting type III and VI collagen formation with modified Rodnan skin score in systemic sclerosis – a cross-sectional study.

June 1, 2019

Biomarkers

Abstract The objective was to investigate blood-based biomarkers of type I (PRO-C1), III (PRO-C3) and VI (PRO-C6) collagen formation in systemic sclerosis (SSc) patients and examine their correlation to modified Rodnan skin score (mRSS). Limited (lSSc,  = 76) and diffuse SSc (dSSc,  = 41) fulfilling the ACR/EULAR 1980 and 2013 classification criteria for SSc and asymptomatic controls […]

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Citrullinated vimentin and biglycan protein fingerprints as candidate serological biomarkers for disease activity in systemic sclerosis: a pilot study.

May 1, 2019

Biomarkers

Abstract Extracellular matrix (ECM) deposition and remodelling in skin and lungs of systemic sclerosis (SSc) subjects lead to release of metabolites/biomarkers into circulation. We investigated if biomarkers of ECM degradation (biglycan and elastin) and macrophage activation (citrullinated vimentin) could identify diffuse SSc (dSSc) subjects from controls and the biomarkers discriminative power. DSSc subjects ( = 40) fulfilling […]

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Synovitis biomarkers: ex vivo characterization of three biomarkers for identification of inflammatory osteoarthritis.

January 1, 2015

Biomarkers

Abstract OBJECTIVE Characterize biomarkers measuring extracellular matrix turnover of inflamed osteoarthritis synovium. METHODS Human primary fibroblast-like synoviocytes and synovial membrane explants (SMEs) treated with various cytokines and growth factors were assessed by C1M, C3M, and acMMP3 in the conditioned medium. RESULTS TNFα significantly increased C1M up to seven-fold (p = 0.0002), C3M up to 24-fold (p = 0.0011), and […]

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Serum cartilage oligomeric matrix protein and development of radiographic and painful knee osteoarthritis. A community-based cohort of middle-aged women.

January 1, 2015

Biomarkers

Abstract CONTEXT AND OBJECTIVE We evaluated the predictive value of serum cartilage oligomeric matrix protein (sCOMP) levels over 20 years on the development of radiographic (RKOA) and painful knee osteoarthritis (KOA) in a longitudinal cohort of middle-aged women. MATERIALS AND METHODS Five hundred and ninety-three women with no baseline KOA underwent 5-year knee radiographs over […]

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Quantification of “end products” of tissue destruction in inflammation may reflect convergence of cytokine and signaling pathways — implications for modern clinical chemistry.

August 1, 2013

Biomarkers

Abstract The degree of inflammation in auto-immune diseases such as rheumatoid arthritis is often assessed in serum and used for diagnostic and prognostic purposes. The serum levels of acute inflammatory signaling molecules (C-reactive protein and serum amyloid A) in conjunction with the important pro-inflammatory cytokines themselves may have limited utility due to several limitations. (1) […]

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A novel marker for assessment of liver matrix remodeling: an enzyme-linked immunosorbent assay (ELISA) detecting a MMP generated type I collagen neo-epitope (C1M).

November 1, 2011

Biomarkers

Abstract A competitive enzyme-linked immunosorbent assay (ELISA) for detection of a type I collagen fragment generated by matrix metalloproteinases (MMP) -2, -9 and -13, was developed (CO1-764 or C1M). The biomarker was evaluated in two preclinical rat models of liver fibrosis: bile duct ligation (BDL) and carbon tetra chloride (CCL4)-treated rats. The assay was further […]

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Immunological detection of the type V collagen propeptide fragment, PVCP-1230, in connective tissue remodeling associated with liver fibrosis.

August 1, 2011

Biomarkers

Abstract AIM Liver fibrosis involves excessive remodeling and deposition of fibrillar extracellular matrix (ECM) components, which leads to malfunction of the organ, causing significant morbidity and mortality. The aim of this study was to assess whether levels of a type V collagen fragment, the propeptide CO5-1230, indicate the amount of collagen deposited during liver fibrosis. […]

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Post-translational modifications of the extracellular matrix are key events in cancer progression: opportunities for biochemical marker development.

May 1, 2011

Biomarkers

Abstract The aim of this review is to discuss the potential usefulness of a novel class of biochemical markers, designated neoepitopes. Neoepitopes are post-translational modifications (PTMs) of proteins and are derived by processes, such as protease cleavage, citrullination, nitrosylation, glycosylation and isomerization. Each PTM results from a specific local physiological or pathobiological process. Identification of […]

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