Serum Hepcidin Immunoassay: Laboratory to Marketplace

血清铁调素免疫测定：从实验室到市场

• 批准号: 8127588
• 负责人: Mark Edward Westerman
• 金额: $ 63.12万
• 依托单位: INTRINSIC LIFESCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-14 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8127588
• 关键词: Address; Adoption; Affect; Affinity; Amino Acids; Anemia; Anemia due to Chronic Disorder; Antibodies; Antibody Formation; Area; Bass; Behavior; Binding; Biological; Biological Assay; Biological Markers; Biological Sciences; Biomedical Research; Cells; Clinical; Clinical Medicine; Collaborations; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Dietary Iron; Disease; Enzyme-Linked Immunosorbent Assay; Epitopes; Equipment and supply inventories; FDA approved; Funding; Generations; Genetic; Goals; Hematology; Hereditary Disease; Hereditary hemochromatosis; Homeostasis; Hormones; Human; Immunoassay; Infection; Inflammatory; Inflammatory Bowel Diseases; Inherited; Intervention; Iron; Iron Metabolism Disorders; Iron Overload; Iron deficiency anemia; Knowledge; Laboratories; Legal patent; Liquid substance; Liver; Malaria; Malignant Neoplasms; Marketing; Measurement; Measures; Mediating; Medical; Molecular; Monoclonal Antibodies; Mus; Mutation; National Institute of Diabetes and Digestive and Kidney Diseases; Oryctolagus cuniculus; Peptides; Performance; Pharmacologic Substance; Phase; Plasma; Plasma Cells; Positioning Attribute; Production; Reagent; Recycling; Refractory; Research; Research Activity; Research Personnel; Resistance; Rheumatoid Arthritis; Role; Sampling; Serum; Small Business Innovation Research Grant; Standardization; Technology; Thalassemia; Translations; Urine; Validation; absorption; base; commercialization; hepcidin; human disease; immunogenicity; improved; iron metabolism; metal transporting protein 1; peptide hormone; polyclonal antibody; preclinical study; prototype; receptor; research and development; tool

DESCRIPTION (provided by applicant): Disorders of iron metabolism are among the most common human diseases. During the last decade, rapid progress has been made in the understanding of the molecular basis or iron homeostasis and its disorders. The peptide hormone hepcidin has emerged as the master regulator of iron metabolism. Dysregulation of hepcidin is the principal or contributing factor in most systemic iron disorders. There is a well recognized unmet need for a robust and widely available clinical assay for serum hepcidin but progress towards this goal has been slowed by the poor immunogenicity of hepcidin. Intrinsic Life Sciences (ILS) developed and validated the world's first serum hepcidin immunoassay (competitive ELISA), that relied on a finite supply of high quality rabbit polyclonal antibodies. In order to increase the availability and standardization of the hepcidin ELISA, Phase I SBIR funding was used to produce murine monoclonal antibodies against hepcidin. Under Phase II of this proposal we will: 1) Use the monoclonal antibodies to optimize and validate a 2nd generation improved competitive ELISA for hepcidin 2) Produce additional monoclonal antibodies to hepcidin and develop and validate a two-monoclonal antibody sandwich ELISA. Successful completion of Phase II will enable ILS to deliver a hepcidin immunoassay prototype suitable for FDA approval and widespread adoption by clinicians and researchers. PUBLIC HEALTH RELEVANCE: With Phase II SBIR funding, Intrinsic Life Sciences (ILS) will develop the first prototype diagnostic tests suitable for FDA-approval for the iron-regulating hormone hepcidin. Measurement of hepcidin will permit greatly improved diagnosis of prevalent genetic and acquired iron disorders and anemias associated with inflammatory diseases and cancers.

描述（由申请人提供）：铁代谢紊乱是人类最常见的疾病之一。在过去的十年中，在理解铁稳态及其紊乱的分子基础方面取得了快速进展。肽激素铁调素已经成为铁代谢的主要调节剂。铁调素的失调是大多数系统性铁障碍的主要或促成因素。对于用于血清铁调素的稳健且广泛可用的临床测定存在公认的未满足的需求，但由于铁调素的免疫原性差，该目标的进展已经放缓。Intrinsic Life Sciences（ILS）开发并验证了世界上第一个血清铁调素免疫测定法（竞争性ELISA），该方法依赖于有限的高质量兔多克隆抗体供应。为了增加铁调素ELISA的可用性和标准化，I期SBIR资金用于生产针对铁调素的鼠单克隆抗体。在该提案的第二阶段，我们将：1）使用单克隆抗体优化和验证第二代改进的铁调素竞争性ELISA; 2）生产额外的铁调素单克隆抗体，并开发和验证双单克隆抗体夹心ELISA。第二阶段的成功完成将使ILS能够提供适合FDA批准和临床医生和研究人员广泛采用的hepcidin免疫测定原型。 公共卫生相关性：在第二阶段SBIR的资助下，内在生命科学公司（ILS）将开发出第一个适合FDA批准的铁调节激素hepcidin的原型诊断测试。铁调素的测量将允许大大改善与炎性疾病和癌症相关的流行性遗传性和获得性铁障碍和贫血的诊断。