SBIR TOPIC 283 PHASE I - DEVELOPMENT OF A MOLECULAR DIAGNOSTIC ASSAY TO DETECT B

SBIR 主题 283 第一阶段 - 开发检测 B 的分子诊断方法

• 批准号: 8354767
• 负责人: ROBERTO FAGNANI
• 金额: $ 14.96万
• 依托单位: ONCONOSTIC TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2012-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8354767
• 关键词: Biological Assay; Biological Markers; Characteristics; Clinical; Clinical Pathology; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Epidermal Growth Factor Receptor; Epitopes; Estrogen Receptors; Formalin; Gene Expression; Generations; Gold; Human; Malignant Neoplasms; Mammary Neoplasms; Molecular; Molecular Diagnostic Testing; Monoclonal Antibodies; Paraffin Embedding; Phase; Proteins; Role; Small Business Innovation Research Grant; System; Testing; Tissues; Tumor Tissue; Validation; base; clinical practice; cost; diagnostic accuracy; malignant breast neoplasm; novel; phase 1 study; protein expression; therapeutic target; trait; transcription factor

A molecular diagnostic test based on immunohistochemical detection of a characteristic protein biomarker will be developed to diagnose basal-like breast cancer (BLBC), similar to those already in routine use for detection of estrogen receptor and human epidermal growth factor receptor 2 (HER2) in breast cancer. The assay will be based on the detection of transcription factor FOXC1 protein utilizing a novel monoclonal antibody optimized for use on formalin-fixed paraffin-embedded breast tumor tissue. FOXC1 has recently been demonstrated by our group to be a characteristic, highly specific tissue level biomarker of BLBC. FOXC1 is also a potential therapeutic target by virtue of its demonstrated critical role in coordinating aggressive cancer traits. This proposal is focused on demonstrating and establishing the proof-of-concept of such a molecular diagnostic assay for the accurate detection of BLBC. Successful completion of this Phase I study is essential prior to undertaking large scale clinical validation of this diagnostic test in Phase II. If successfully validated, the molecular diagnostic test based on FOXC1 protein expression would greatly simplify the diagnosis of BLBC in routine clinical practice owing to the low cost and ease of integration of the proposed testing system into currently existing clinical pathology practice.

将开发基于特征性蛋白质生物标志物的免疫组织化学检测的分子诊断测试，以诊断基底样乳腺癌（BLBC），类似于常规用于检测乳腺癌中雌激素受体和人表皮生长因子受体2（HER2）的测试。该试验将基于利用一种新型单克隆抗体检测转录因子FOXC 1蛋白，该抗体针对福尔马林固定石蜡包埋的乳腺肿瘤组织进行了优化。FOXC 1是BLBC的一种特征性的、高度特异性的组织水平生物标志物。FOXC 1也是一个潜在的治疗靶点，因为它在协调侵袭性癌症特征方面发挥了关键作用。该提案的重点是证明和建立这种用于BLBC准确检测的分子诊断测定的概念验证。在II期对该诊断测试进行大规模临床验证之前，成功完成I期研究至关重要。如果成功验证，基于FOXC 1蛋白表达的分子诊断测试将极大地简化BLBC在常规临床实践中的诊断，这是由于所提出的测试系统的低成本和易于集成到当前现有的临床病理学实践中。