Biomarker Analysis Services for Primary Sclerosing Cholangitis
Drug R&D Solutions

Biomarker Analysis Services for Primary Sclerosing Cholangitis

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Protheragen offers specialized biomarker analysis services tailored to support research and drug discovery for Primary Sclerosing Cholangitis (PSC). Our comprehensive biomarker panel is designed to advance the understanding of PSC pathophysiology and accelerate therapeutic development. All services are exclusively focused on drug discovery through preclinical development stages and do not include clinical diagnostic services.

Biomarker Discovery and Identification

The foundation of effective therapeutic intervention in PSC lies in the robust discovery and identification of relevant biomarkers. Protheragen's biomarker discovery services integrate advanced screening and validation processes to identify molecular signatures associated with disease mechanisms. Our approach involves systematic screening of candidate biomarkers using high-throughput platforms, followed by rigorous validation to ensure their relevance and utility in preclinical drug development pipelines.

Multi Omics: Leveraging cutting-edge genomics, transcriptomics, proteomics, and metabolomics technologies, Protheragen enables a comprehensive study of biological systems underlying PSC. Our multi-omics approach facilitates the identification of DNA, RNA, protein, and metabolite biomarkers, providing insights into disease-relevant pathways such as immune dysregulation, inflammation, fibrosis, and bile acid metabolism. This integrative analysis supports the elucidation of complex biological networks implicated in PSC, driving informed therapeutic strategies.

Candidate Validation: Our candidate validation strategies employ a combination of molecular, cellular, and biochemical assays to confirm the association of identified biomarkers with PSC pathophysiology. Preliminary screening processes include quantitative expression analysis, pathway enrichment, and functional studies in relevant preclinical models. Candidates are prioritized based on criteria such as biological plausibility, reproducibility, and relevance to disease mechanisms, ensuring that only the most promising biomarkers advance for further development.

Biomarker Assay Development and Validation

Diverse Technological Platforms: Protheragen offers custom assay development capabilities across a diverse array of technological platforms, enabling adaptation to specific project requirements. Our platforms are designed for flexibility, scalability, and compatibility with various sample types, supporting the full spectrum of preclinical biomarker research.

Immunoassays: We develop and implement ELISA, chemiluminescent, and multiplex immunoassays for sensitive and specific detection of protein biomarkers in biological samples.

Mass Spectrometry: Our LC-MS/MS platforms provide high-resolution, quantitative analysis of proteins, peptides, and metabolites, supporting both targeted and discovery-based biomarker studies.

Flow Cytometry: We utilize flow cytometry for multiparametric analysis of cell populations, enabling the assessment of surface and intracellular biomarker expression.

Molecular Diagnostics: Our molecular diagnostics capabilities include PCR-based and next-generation sequencing assays for quantification and mutation analysis of nucleic acid biomarkers.

Histopathology And Imaging: We offer histopathological evaluation and advanced imaging techniques to localize and quantify biomarkers within tissue samples, supporting spatial and morphological analyses.

Rigorous Method Validation: All analytical methods undergo rigorous validation in accordance with established guidelines to ensure accuracy, precision, sensitivity, specificity, and reproducibility. Performance characteristics are systematically evaluated, and comprehensive quality control measures are implemented throughout the process to maintain data integrity and reliability.

Biomarker Quantitative and Qualitative Analysis

Protheragen provides robust quantitative analysis capabilities, enabling precise measurement of biomarker levels across diverse sample types. Our analytical workflows are designed for reproducibility, scalability, and high data quality, supporting the generation of actionable insights for PSC research.

Sample Analysis: We handle a wide range of sample types, including serum, plasma, tissue, and cell lysates. Our analysis protocols are standardized and optimized for each sample matrix to ensure consistency and reliability. Stringent quality control measures are applied at every step, from sample receipt to data reporting, to guarantee the integrity of results.

High Throughput Capabilities: Our high-throughput, multiplexed analytical platforms enable efficient processing of large sample cohorts, conserving sample volume while maximizing data output. This approach enhances study efficiency, reduces turnaround times, and supports the comprehensive evaluation of biomarker panels in preclinical research.

Key Biomarkers for Primary Sclerosing Cholangitis Drug Development

Gene Target Biological Function Application as a Biomarker
C-C motif chemokine ligand 24 (CCL24) C-C motif chemokine ligand 24 (CCL24), also known as eotaxin-2, is a member of the CC chemokine family. It is primarily produced by activated monocytes, macrophages, and epithelial cells. CCL24 binds to the chemokine receptor CCR3, which is predominantly expressed on eosinophils, basophils, and certain T lymphocytes. Its main biological function is to induce chemotaxis of eosinophils and other CCR3-expressing leukocytes to sites of inflammation. CCL24 plays a significant role in the regulation of immune responses, particularly in allergic inflammation and diseases characterized by eosinophil infiltration, such as asthma and atopic dermatitis. CCL24 has been studied as a biomarker in various inflammatory and allergic conditions. Elevated levels of CCL24 have been reported in the serum, bronchoalveolar lavage fluid, or tissue samples of individuals with diseases such as asthma, allergic rhinitis, atopic dermatitis, and certain autoimmune disorders. Measurement of CCL24 concentrations can be used in research settings to assess the degree of eosinophilic inflammation or to monitor disease activity and response to therapy in these conditions.
C-X-C motif chemokine ligand 8 (CXCL8) C-X-C motif chemokine ligand 8 (CXCL8), also known as interleukin-8 (IL-8), is a pro-inflammatory chemokine primarily produced by macrophages, epithelial cells, and other cell types in response to inflammatory stimuli. CXCL8 functions as a chemoattractant, directing the migration of neutrophils and other immune cells to sites of infection or tissue injury. It binds to specific G protein-coupled receptors, CXCR1 and CXCR2, on the surface of target cells, leading to activation of intracellular signaling pathways that promote chemotaxis, degranulation, and the respiratory burst in neutrophils. CXCL8 also plays a role in angiogenesis and has been implicated in the regulation of immune responses and tissue remodeling. CXCL8 has been used as a biomarker to assess inflammatory activity in a variety of clinical contexts. Elevated levels of CXCL8 have been detected in serum, plasma, or other biological fluids in association with inflammatory diseases such as sepsis, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), and certain cancers. Measurement of CXCL8 concentrations may provide information regarding the presence and extent of inflammation, disease progression, or response to therapy in these settings.
PYD and CARD domain containing (PYCARD) PYD and CARD domain containing (PYCARD), also known as ASC (apoptosis-associated speck-like protein containing a CARD), is an adaptor protein that plays a central role in the innate immune response. PYCARD contains two protein-protein interaction domains: a pyrin domain (PYD) and a caspase recruitment domain (CARD). It is a key component of the inflammasome complex, where it facilitates the assembly of inflammasome sensors (such as NLRP3) with pro-caspase-1. Upon activation, PYCARD oligomerizes to form large multiprotein complexes known as 'ASC specks', which promote the autocatalytic activation of caspase-1. Activated caspase-1 then processes pro-inflammatory cytokines, such as IL-1β and IL-18, into their mature forms and induces a type of programmed cell death called pyroptosis. PYCARD is thus crucial for mediating inflammatory responses and host defense mechanisms. PYCARD has been investigated as a biomarker in contexts involving inflammasome activation and inflammatory diseases. Elevated levels of PYCARD and its oligomerized form (ASC specks) have been detected in biological fluids and tissues in conditions such as autoinflammatory syndromes, neuroinflammatory diseases, and certain cancers. Measurement of PYCARD expression or the presence of ASC specks can provide information about inflammasome activity and inflammatory status, supporting its use in research and potential clinical assessment of inflammation-related disorders.
interleukin 1 beta (IL1B) Interleukin 1 beta (IL1B) is a pro-inflammatory cytokine produced primarily by activated macrophages, monocytes, and dendritic cells. It plays a central role in the regulation of immune and inflammatory responses. IL1B is synthesized as an inactive precursor (pro-IL1B) and is cleaved by caspase-1 to its active form, which is then secreted. Upon release, IL1B binds to the interleukin-1 receptor (IL-1R), activating signaling pathways such as NF-κB and MAPK, leading to the expression of various genes involved in inflammation, cell proliferation, differentiation, and apoptosis. IL1B is also implicated in the induction of fever, promotion of leukocyte infiltration, and stimulation of acute phase protein synthesis. IL1B is measured in biological fluids such as serum, plasma, or cerebrospinal fluid as an indicator of inflammatory activity. Its levels are used in research and clinical contexts to assess the presence and intensity of inflammation in conditions such as autoimmune diseases, infectious diseases, and certain cancers. Elevated IL1B concentrations can reflect active inflammatory processes and have been associated with disease severity and progression in disorders like rheumatoid arthritis, sepsis, and atherosclerosis.
interleukin 2 (IL2) Interleukin 2 (IL2) is a cytokine produced primarily by activated CD4+ T lymphocytes. It plays a central role in the immune system by promoting the proliferation, differentiation, and survival of T cells, particularly regulatory T cells and cytotoxic T cells. IL2 also stimulates the growth and activity of natural killer (NK) cells and enhances the cytolytic activity of lymphocytes. Through these actions, IL2 is critical for the development and maintenance of immune tolerance and the orchestration of adaptive immune responses. IL2 levels have been measured in various biological fluids, such as serum and plasma, to assess immune activation and function. Elevated or decreased concentrations of IL2 have been associated with immune-mediated conditions, including autoimmune diseases, infections, and certain cancers. IL2 measurements have been used in research and clinical studies to monitor immune responses, evaluate disease activity, and assess the efficacy of immunotherapies.
nuclear receptor subfamily 1 group H member 4 (NR1H4) Nuclear receptor subfamily 1 group H member 4 (NR1H4), also known as the farnesoid X receptor (FXR), is a ligand-activated transcription factor belonging to the nuclear receptor superfamily. NR1H4 is primarily expressed in the liver, intestine, kidney, and adrenal glands. Its main physiological function is to regulate bile acid homeostasis by modulating the transcription of genes involved in bile acid synthesis, conjugation, and transport. Upon activation by bile acids, NR1H4 represses the expression of CYP7A1, the rate-limiting enzyme in bile acid synthesis, and induces genes such as BSEP (bile salt export pump) to promote bile acid efflux. NR1H4 also plays roles in lipid metabolism, glucose homeostasis, and the regulation of inflammatory responses in the liver and gastrointestinal tract. NR1H4 expression and activity have been studied as potential biomarkers in liver-related disorders. Altered NR1H4 levels have been reported in conditions such as cholestatic liver diseases, nonalcoholic fatty liver disease (NAFLD), and hepatocellular carcinoma. Measurement of NR1H4 expression or its target gene profiles in tissue samples may provide information about bile acid metabolism and liver function. Additionally, NR1H4 has been investigated in the context of drug-induced liver injury and metabolic syndromes, where its status may reflect underlying pathophysiological changes.
nuclear receptor subfamily 1 group I member 2 (NR1I2) Nuclear receptor subfamily 1 group I member 2 (NR1I2), also known as the pregnane X receptor (PXR), is a ligand-activated transcription factor belonging to the nuclear receptor superfamily. NR1I2 is primarily expressed in the liver and intestine and plays a central role in the regulation of genes involved in the metabolism and transport of endogenous and exogenous compounds. Upon activation by a wide variety of ligands—including prescription drugs, xenobiotics, and endogenous steroids—NR1I2 forms a heterodimer with the retinoid X receptor (RXR) and binds to specific response elements in the promoter regions of target genes. This leads to the transcriptional activation of genes encoding phase I enzymes (such as cytochrome P450 3A4), phase II enzymes (such as UDP-glucuronosyltransferases), and drug transporters (such as ABCB1/MDR1), thereby modulating the detoxification and clearance of potentially harmful substances. NR1I2 expression and activity have been investigated as biomarkers for assessing inter-individual variability in drug metabolism and response. Its expression levels or genetic polymorphisms can be associated with altered metabolism of pharmaceuticals, influencing drug efficacy and risk of adverse drug reactions. NR1I2 has also been studied as a marker of exposure to xenobiotics and environmental chemicals, due to its inducibility by a broad range of compounds. Additionally, its expression has been evaluated in the context of liver diseases and certain cancers, where altered NR1I2 activity may affect disease progression or therapeutic outcomes.
toll like receptor 9 (TLR9) Toll-like receptor 9 (TLR9) is a member of the Toll-like receptor family, which plays a key role in the innate immune system. TLR9 is primarily expressed in plasmacytoid dendritic cells, B cells, and certain other immune cell types. It is localized to intracellular endosomal compartments, where it recognizes unmethylated CpG motifs commonly found in bacterial and viral DNA but rare in vertebrate genomes. Upon binding to these CpG DNA motifs, TLR9 initiates a signaling cascade through the adaptor protein MyD88, leading to the activation of transcription factors such as NF-κB and IRF7. This results in the production of type I interferons and pro-inflammatory cytokines, contributing to the immune response against pathogens. TLR9 expression and activation status have been studied as potential biomarkers in various clinical contexts. In infectious diseases, altered TLR9 levels may reflect immune system activation or dysregulation. In oncology, TLR9 expression in tumor tissue or immune cells has been investigated in relation to tumor progression, prognosis, and response to certain immunotherapies. Additionally, in autoimmune diseases such as systemic lupus erythematosus, aberrant TLR9 activity has been associated with disease activity. Measurement of TLR9 expression or function is used in research settings to assess immune status, disease associations, or therapeutic response.
transforming growth factor beta 1 (TGFB1) Transforming growth factor beta 1 (TGFB1) is a multifunctional cytokine that plays a central role in the regulation of cell growth, differentiation, apoptosis, and homeostasis in various tissues. It is a member of the TGF-beta superfamily and is secreted as a latent complex that requires activation. TGFB1 exerts its effects by binding to specific cell surface receptors, leading to the activation of SMAD and non-SMAD signaling pathways. It is involved in the modulation of immune responses, regulation of extracellular matrix production, and maintenance of tissue architecture. TGFB1 is also a key mediator of fibrosis, wound healing, and immune tolerance. TGFB1 has been studied as a biomarker in several clinical contexts. Its expression levels have been measured in tissue, blood, and other body fluids to assess disease activity, prognosis, or therapeutic response. Elevated TGFB1 levels have been associated with fibrotic diseases such as systemic sclerosis, idiopathic pulmonary fibrosis, and chronic kidney disease, as well as with certain cancers. In these settings, TGFB1 measurements may provide information on the extent of tissue remodeling, disease progression, or the presence of an altered immune environment.

Partner with Protheragen to Advance Innovation

Explore Research Opportunities with Protheragen. Our biomarker research services for Primary Sclerosing Cholangitis leverage state-of-the-art technologies and scientific expertise to support exploratory and preclinical research. The biomarkers discussed are considered research targets only; we do not claim any as validated or mandatory for PSC. Our focus remains on advancing biomarker discovery and characterization during preclinical development, maintaining scientific objectivity and flexibility for our partners.

We invite you to connect with Protheragen to discuss collaborative opportunities in exploratory biomarker research for Primary Sclerosing Cholangitis. Let's advance scientific knowledge and innovation together through objective, research-driven partnership.

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