Detecting breast cancer with a simple blood test using an accessible and low-cost novel real-time platform

使用易于访问且低成本的新颖实时平台，通过简单的血液测试来检测乳腺癌

• 批准号: 9346546
• 负责人: Eagappanath Thiruppathi
• 金额: $ 30万
• 依托单位: INANOVATE, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-23 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9346546
• 关键词: Antigens; Autoantibodies; Benchmarking; Biological Assay; Biological Markers; Biopsy; Blood Tests; Breast Cancer Detection; Breast Cancer Early Detection; Breast biopsy; Cancer Diagnostics; Cancerous; Classification; Clinical; Clinical Trials; Cost Savings; Data; Data Collection; Data Set; Detection; Diagnosis; Diagnostic; Diagnostic tests; Environment; Enzyme-Linked Immunosorbent Assay; Fluorescence; Healthcare; Immune system; Laboratories; Lesion; Malignant Neoplasms; Mammography; Measures; Microfluidic Microchips; Modeling; Pain; Patients; Performance; Phase; Preparation; Production; Productivity; Radiation exposure; Reporting; Research; Risk; Sampling; Savings; Secure; Sensitivity and Specificity; Small Business Innovation Research Grant; Specificity; Statistical Models; System; Techniques; Testing; Time; Tumor Antigens; United States; Variant; Woman; Work; base; biochip; biomarker panel; breast cancer diagnosis; cancer biomarkers; clinical diagnostics; cost; design; diagnostic assay; diagnostic biomarker; economic cost; follow-up; improved; inflammatory marker; innovation; malignant breast neoplasm; manufacturing process; minimally invasive; mortality; next generation; novel; novel diagnostics; phase 2 study; protein aggregation; prototype; research and development; screening; social; specific biomarkers; tool; tumor

Project Summary  Although widespread screening by mammography has successfully cut mortality from breast cancer (BCa),  the exquisite sensitivity of the technique results in a startling number of “false positives.”  Of approximately 3.9  million women who receive a positive mammogram each year, fewer than 250,000 will be diagnosed with BCa.  Cumulatively, the economic cost of follow-­up diagnostics to resolve false-­positive mammograms is  approximately $4 billion annually, while the social consequences include lost productivity and more than 3  million women exposed to the risks associated with subsequent diagnostics and treatment (e.g., radiation  exposure, pain and discomfort following a breast biopsy, etc.). Hence, a minimally invasive, rapid, and  inexpensive blood test that could be used as a “rule-­out” screen for BCa following a positive mammogram  potentially offers significant healthcare saving and reduced patient burden.  Currently available commercial platforms for measuring biomarkers suffer from narrow detection range  and/or low throughput. In turn, these limitations constrain the design of diagnostic tests based on biomarkers,  which restricts their clinical utility. To surmount these challenges, Inanovate reimagined the approach to  biomarker detection. The result is a superior biochip platform, the Bio-­ID, which can detect biomarkers (e.g.,  autoantibodies to tumor-­associated antigens) across a 7-­log range. For comparison;; the best competitor  platform available covers only a 4-­log range. In addition, the Bio-­ID system is a high-­throughput format that can  be configured to detect any combination of biomarkers, making it a powerful tool for clinical and R&D tool for  designing next-­generation biomarker-­based diagnostic assays.   In this Fast-­track SBIR, Inanovate seeks to advance the Bio-­ID platform toward commercial launch and to  demonstrate its utility by developing a BCa diagnostic that can be used to exclude a breast cancer diagnosis  following a positive screening mammogram. The test is based on a novel panel of 31 BCa and immune system  biomarkers identified by Inanovate and its collaborators at Sanford Research. In Phase I, the biochip assay will  be optimized on the Bio-­ID system (Aim 1), and the system will be benchmarked to previously characterized  patient samples and a single-­sample predictive model for differentiating healthy and cancerous samples will be  constructed (Aim 2). In Phase II, Inanovate will prototype an upgraded Bio-­ID system for deployment in clinical  diagnostic laboratories (Aim 1), the predictive model from Phase I will be challenged with a larger dataset (Aim  2), and Inanovate will prepare for regulatory approvals and secure commercial partners to advance the  platform and diagnostic test to market (Aim 3).   The successful completion of this work will yield a cost-­saving  BCa diagnostic (compared to biopsy) and advance a revolutionary new platform that will facilitate biomarker  research and enable the next generation of diagnostics to be developed.

项目总结