Biomarker Analysis Services for Amyloidosis
Protheragen offers specialized biomarker analysis services dedicated exclusively to supporting drug discovery and preclinical development for Amyloidosis. Our comprehensive biomarker panel is designed to provide deep insights into the molecular and cellular mechanisms underlying Amyloidosis, enabling a robust understanding of disease pathophysiology. All services provided by Protheragen are strictly limited to research and preclinical drug development; we do not offer clinical diagnostic services.
Effective therapeutic intervention for Amyloidosis begins with precise biomarker discovery and identification. Protheragen’s biomarker discovery services are foundational to the drug development process, enabling the identification of molecular indicators associated with disease onset, progression, and therapeutic response. Our approach integrates advanced screening and rigorous validation methodologies to ensure that identified biomarkers are relevant and reproducible within the context of Amyloidosis. The process encompasses in silico analysis, in vitro screening, and preclinical in vivo validation to establish robust research candidates for downstream applications.
Multi Omics: We employ a cutting-edge multi-omics strategy that integrates genomics, transcriptomics, proteomics, and metabolomics to provide a holistic view of biological systems implicated in Amyloidosis. This comprehensive approach enables the identification and characterization of DNA, RNA, protein, and metabolite biomarkers relevant to disease mechanisms. By leveraging high-throughput sequencing, quantitative PCR, mass spectrometry, and advanced bioinformatics, we dissect complex disease pathways such as amyloid precursor protein processing, protein misfolding, immune modulation, and inflammatory signaling—each critical to Amyloidosis pathogenesis.
Candidate Validation: Protheragen utilizes rigorous validation strategies to prioritize biomarker candidates with direct relevance to Amyloidosis pathophysiology. Validation workflows include orthogonal assay confirmation, cross-platform reproducibility testing, and correlation with preclinical disease models. Preliminary screening processes assess sensitivity, specificity, and biological plausibility, while selection criteria focus on mechanistic association, detectability in accessible matrices, and translational potential for drug development. Only candidates demonstrating robust association with disease-related pathways and consistent performance across validation stages are advanced for further study.
Diverse Technological Platforms: Our custom assay development capabilities span a wide array of technological platforms, allowing us to tailor analytical solutions to the unique requirements of Amyloidosis research. We adapt and optimize platforms for immunoassays, mass spectrometry, flow cytometry, molecular diagnostics, and histopathology/imaging to ensure sensitive and specific detection of biomarker candidates. This flexibility enables us to address diverse analytical challenges and support the evolving needs of preclinical drug discovery.
Immunoassays: We offer development and optimization of immunoassays, including ELISA, chemiluminescent, and multiplex bead-based platforms, for quantitative and qualitative detection of protein biomarkers relevant to Amyloidosis.
Mass Spectrometry: Our LC-MS/MS platforms enable highly sensitive and specific quantification of proteins, peptides, and metabolites, supporting both targeted and discovery-based biomarker analysis.
Flow Cytometry: We utilize flow cytometry for cellular phenotyping and quantification of cell-surface and intracellular biomarkers, facilitating the study of immune and inflammatory pathways in Amyloidosis.
Molecular Diagnostics: We develop molecular assays, such as qPCR and digital PCR, for detection of gene expression changes, mutations, and transcriptomic biomarkers implicated in Amyloidosis.
Histopathology And Imaging: Our services include immunohistochemistry, tissue staining, and advanced imaging modalities for localization and visualization of amyloid deposits and associated biomarkers in preclinical tissue samples.
Rigorous Method Validation: All analytical methods developed by Protheragen undergo rigorous validation in accordance with preclinical research guidelines. Validation parameters assessed include sensitivity, specificity, linearity, accuracy, precision, reproducibility, and robustness. We implement stringent quality control measures at every stage of assay development and analysis to ensure data integrity, reliability, and reproducibility, supporting the highest standards in preclinical biomarker research.
Protheragen provides quantitative analysis capabilities for a diverse range of biomarker types, including proteins, peptides, nucleic acids, and metabolites. Our platforms support both absolute and relative quantification, enabling detailed profiling of biomarker expression and dynamics in preclinical models of Amyloidosis. Advanced data analysis pipelines facilitate comprehensive interpretation and integration of multi-omics datasets.
Sample Analysis: We handle a variety of preclinical sample types, including plasma, serum, cerebrospinal fluid, tissue homogenates, and cell lysates. Our analysis protocols are tailored to the specific requirements of each matrix and biomarker class, with rigorous sample preparation, processing, and storage procedures to maintain analyte stability and integrity. All analyses are conducted under strict quality assurance frameworks to ensure reproducible and high-quality results.
High Throughput Capabilities: Our high-throughput analytical platforms enable efficient, multiplexed analysis of large sample cohorts, maximizing data output while conserving precious preclinical samples. Multiplex immunoassays, automated sample processing, and parallelized mass spectrometry workflows accelerate biomarker screening and validation, reducing turnaround times and supporting rapid decision-making in drug discovery pipelines.
| Gene Target | Biological Function | Application as a Biomarker |
|---|---|---|
| amyloid P component, serum (APCS) | Amyloid P component, serum (APCS), also known as serum amyloid P component (SAP), is a highly conserved plasma protein belonging to the pentraxin family. It is characterized by its pentameric structure and calcium-dependent ligand-binding properties. APCS is involved in innate immunity, where it can bind to various ligands, including DNA, chromatin, apoptotic cells, and certain microbial components, thereby facilitating their clearance. It also binds to amyloid fibrils, stabilizing them and protecting them from proteolytic degradation. This interaction with amyloid deposits is a key feature of its biological function, as APCS is universally present in all types of amyloid deposits in humans. | APCS has been utilized as a biomarker primarily in the context of systemic amyloidosis. Its presence in amyloid deposits can be detected by immunohistochemistry or other immunoassays, aiding in the identification and characterization of amyloid in tissue biopsies. Additionally, circulating levels of APCS have been studied in relation to amyloid diseases and inflammatory conditions, although its use in these contexts is typically adjunctive to other diagnostic criteria. |
| amyloid beta precursor protein (APP) | Amyloid beta precursor protein (APP) is a type I transmembrane glycoprotein that is widely expressed in many tissues, including the central nervous system. APP undergoes proteolytic processing through two major pathways: the non-amyloidogenic pathway, which precludes the formation of amyloid beta peptides, and the amyloidogenic pathway, which involves sequential cleavage by beta-secretase and gamma-secretase to generate amyloid beta (Aβ) peptides. These Aβ peptides can aggregate to form extracellular plaques. Physiologically, APP is involved in synaptic formation and repair, neuronal growth, cell adhesion, and intracellular signaling. The full spectrum of its physiological roles is still under investigation, but its proteolytic fragments are known to participate in several cellular processes. | APP and its proteolytic products, particularly amyloid beta peptides (such as Aβ40 and Aβ42), are measured in cerebrospinal fluid (CSF) and plasma as biomarkers in the context of neurodegenerative diseases, especially Alzheimer's disease. Decreased levels of Aβ42 in CSF, as well as changes in the ratio of Aβ42 to Aβ40, are associated with amyloid plaque deposition in the brain. These measurements are used in research and clinical settings to aid in the assessment of amyloid pathology and disease progression. |
| apolipoprotein A1 (APOA1) | Apolipoprotein A1 (APOA1) is the major protein component of high-density lipoprotein (HDL) particles in plasma. It plays a central role in lipid metabolism, particularly in the reverse transport of cholesterol from peripheral tissues to the liver for excretion. APOA1 acts as a cofactor for lecithin-cholesterol acyltransferase (LCAT), an enzyme essential for the maturation of HDL particles and the esterification of cholesterol. Through these functions, APOA1 contributes to the maintenance of cholesterol homeostasis and is involved in anti-inflammatory and antioxidant processes associated with HDL. | APOA1 levels in plasma or serum are commonly measured as an indicator of HDL quantity and function. Quantification of APOA1 is used in the assessment of lipid disorders and cardiovascular risk, as reduced APOA1 concentrations are associated with an increased risk of atherosclerotic cardiovascular disease. Additionally, APOA1 has been investigated as a biomarker in other conditions, including liver disease and certain inflammatory states, due to its role in lipid transport and systemic inflammation. |
| beta-2-microglobulin (B2M) | Beta-2-microglobulin (B2M) is a low molecular weight protein that forms the light chain component of major histocompatibility complex (MHC) class I molecules, which are present on the surface of nearly all nucleated cells. B2M associates non-covalently with the alpha chain of MHC class I molecules, contributing to their structural stability and proper expression on the cell surface. Through its role in MHC class I, B2M is involved in the presentation of endogenous peptide antigens to cytotoxic T lymphocytes, facilitating immune surveillance and recognition of infected or malignant cells. B2M is continuously shed from cell surfaces into the circulation as a result of normal cellular turnover. | Beta-2-microglobulin is used as a biomarker in several clinical contexts. Elevated levels of B2M in blood or urine are observed in conditions with increased cell turnover or impaired renal function, as the protein is filtered at the glomerulus and almost completely reabsorbed and degraded in the proximal tubules. Increased serum B2M concentrations are associated with hematologic malignancies such as multiple myeloma, chronic lymphocytic leukemia, and lymphomas, where it is used as a prognostic indicator. Additionally, B2M is measured to assess renal tubular function and monitor patients with chronic kidney disease, as impaired renal clearance leads to its accumulation. |
| caspase 3 (CASP3) | Caspase 3 (CASP3) is a cysteine-aspartic acid protease that plays a central role in the execution phase of apoptosis, or programmed cell death. It is synthesized as an inactive proenzyme (zymogen) and becomes activated through proteolytic cleavage by upstream initiator caspases, such as caspase 8 or caspase 9, in response to pro-apoptotic signals. Once activated, caspase 3 cleaves various cellular substrates, including poly (ADP-ribose) polymerase (PARP) and other structural and regulatory proteins, leading to the morphological and biochemical changes characteristic of apoptosis, such as DNA fragmentation, chromatin condensation, and membrane blebbing. | CASP3 is widely utilized as a biomarker for apoptosis in both experimental and clinical contexts. Its activated (cleaved) form is commonly detected to assess the occurrence and extent of apoptotic cell death in tissue samples, cell cultures, and disease states. Measurement of CASP3 activity or detection of its cleaved substrates is employed in studies of cancer, neurodegenerative diseases, and tissue injury, among other conditions, to evaluate cell death dynamics and therapeutic responses. |
| interleukin 6 (IL6) | Interleukin 6 (IL6) is a multifunctional cytokine produced by a variety of cell types, including T cells, B cells, macrophages, fibroblasts, and endothelial cells. It plays a central role in regulating immune responses, inflammation, hematopoiesis, and the acute phase response. IL6 mediates its effects through binding to the IL6 receptor complex, which activates intracellular signaling pathways such as the JAK/STAT pathway. Its functions include promoting the differentiation of B cells into antibody-producing plasma cells, stimulating the production of acute phase proteins by the liver, and modulating the balance between pro-inflammatory and anti-inflammatory activities. IL6 also influences the differentiation of T helper cells and is involved in the regulation of metabolic, regenerative, and neural processes. | IL6 is commonly measured in clinical and research settings as a biomarker of inflammation and immune activation. Elevated levels of IL6 in blood or other biological fluids have been associated with various inflammatory and infectious conditions, such as sepsis, rheumatoid arthritis, and COVID-19. It has also been studied as a marker of disease severity and progression in autoimmune disorders, malignancies, and cardiovascular diseases. Measurement of IL6 can assist in the assessment of inflammatory status and may help in monitoring response to therapy in certain contexts. |
| leukocyte cell derived chemotaxin 2 (LECT2) | Leukocyte cell derived chemotaxin 2 (LECT2) is a secreted protein primarily produced by hepatocytes in the liver. It is involved in several physiological processes, including modulation of immune responses, chemotaxis of neutrophils, and regulation of inflammation. LECT2 has been shown to participate in the recruitment and activation of immune cells at sites of tissue injury or infection. Additionally, it plays a role in metabolic regulation and has been implicated in the pathogenesis of certain liver diseases, such as nonalcoholic fatty liver disease. LECT2 can also influence bone metabolism and has been associated with amyloid deposition in certain forms of amyloidosis. | LECT2 has been studied as a biomarker in various clinical contexts. Its serum levels have been investigated for their association with liver diseases, including acute and chronic liver injury, nonalcoholic fatty liver disease, and hepatocellular carcinoma. LECT2 is also recognized as the precursor protein for LECT2 amyloidosis, a form of systemic amyloidosis characterized by amyloid deposits derived from LECT2. In this context, tissue identification of LECT2 amyloid can aid in the diagnosis of this specific amyloidosis subtype. Furthermore, altered LECT2 levels have been explored as potential indicators of metabolic syndrome, inflammation, and certain cancers. |
| microtubule associated protein tau (MAPT) | Microtubule associated protein tau (MAPT) encodes the tau protein, which is primarily expressed in neurons of the central nervous system. Tau is involved in the stabilization and assembly of microtubules, which are essential components of the neuronal cytoskeleton. By binding to tubulin, tau promotes microtubule polymerization and maintains their structural integrity, supporting axonal transport and neuronal morphology. Tau undergoes various post-translational modifications, such as phosphorylation, which regulate its affinity for microtubules and its functional role in neuronal cells. | MAPT and its encoded tau protein are used as biomarkers in the context of neurodegenerative diseases, particularly tauopathies such as Alzheimer's disease and frontotemporal dementia. Abnormal hyperphosphorylation and aggregation of tau are characteristic features of these conditions. Measurement of total tau and phosphorylated tau levels in cerebrospinal fluid (CSF) is applied in clinical and research settings to aid in the assessment of neurodegeneration and to differentiate between various forms of dementia. Additionally, tau pathology can be visualized in vivo using positron emission tomography (PET) imaging with tau-specific ligands. |
| transthyretin (TTR) | Transthyretin (TTR) is a tetrameric transport protein primarily synthesized in the liver and choroid plexus of the brain. It functions mainly to transport thyroxine (T4) and retinol (vitamin A) by binding to retinol-binding protein. In plasma, TTR is responsible for carrying approximately 10–15% of circulating T4, with the remainder transported by other proteins such as thyroxine-binding globulin and albumin. In the cerebrospinal fluid, TTR is the major carrier of T4. The protein also plays a role in maintaining the stability of retinol-binding protein, thereby facilitating the transport of vitamin A. Structurally, TTR is known for its tendency to misfold and aggregate under certain conditions, leading to amyloid fibril formation. | Transthyretin is utilized as a biomarker in several clinical contexts. In nutritional assessment, serum TTR (also known as prealbumin) levels are measured as an indicator of protein-energy status due to its relatively short half-life. Decreased TTR concentrations have been associated with malnutrition, inflammation, and liver dysfunction. Additionally, TTR measurement is used in the evaluation of certain hereditary and acquired amyloidoses, such as transthyretin amyloidosis (ATTR), where mutations or misfolding of TTR lead to amyloid deposits in organs and tissues. In these settings, TTR levels and genetic analysis can aid in diagnosis and disease monitoring. |
| tumor necrosis factor (TNF) | Tumor necrosis factor (TNF) is a pro-inflammatory cytokine primarily produced by activated macrophages, as well as other immune and non-immune cells. TNF plays a central role in the regulation of immune responses, inflammation, and apoptosis. It exerts its effects by binding to TNF receptors (TNFR1 and TNFR2) on target cells, initiating signaling cascades that can lead to cell survival, differentiation, or programmed cell death. TNF is instrumental in host defense mechanisms against infections and is involved in the pathogenesis of various inflammatory and autoimmune diseases. It also contributes to the regulation of other cytokines, the activation of endothelial cells, and the recruitment of immune cells to sites of inflammation. | TNF levels in blood or tissue samples are measured in clinical and research settings to assess the presence and severity of inflammatory processes. Elevated TNF concentrations have been observed in conditions such as rheumatoid arthritis, inflammatory bowel disease, sepsis, and certain cancers. TNF is used as a biomarker to monitor disease activity, evaluate response to anti-TNF therapies, and aid in the characterization of inflammatory states. |
Explore Research Opportunities with Protheragen. Our biomarker research services offer a comprehensive suite of technologies and analytical platforms for the exploration and characterization of Amyloidosis-related biomarkers in preclinical drug discovery. All biomarkers described are research targets only, and we do not claim any as validated or required for any application. Our work is strictly focused on exploratory and preclinical research, maintaining scientific objectivity and flexibility to meet diverse research needs.
We invite you to connect with Protheragen to discuss collaborative opportunities in Amyloidosis biomarker research. Our focus is on the exploratory and scientific aspects of biomarker discovery and analysis, fostering knowledge exchange and advancing preclinical research. Let’s work together to drive innovation in Amyloidosis therapeutic development.
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