Establishing Clinical Feasibility of the Raman Assay for Colorectal Cancer

建立结直肠癌拉曼检测的临床可行性

基本信息

批准号：
8903926
负责人：
Patrick Treado
金额：
$ 12.35万
依托单位：
CHEMIMAGE CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-01 至 2015-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8903926
关键词：
Address Affect African American Algorithmic Software Award Benign Biological Assay Blood specimen Cancerous Chemicals Classification Clinical Clinical Research Collaborations Collection Colonoscopy Colorectal Cancer Comorbidity Controlled Study Detection Diagnosis Diagnostic Discrimination Disease Disease Management Early Diagnosis Evaluation Exhibits Feasibility Studies Fecal occult blood Future Gastroenterologist Goals Health Health Professional Healthcare Human Immunoglobulin G In Vitro Institutional Review Boards Lasers Maps Methodology Methods Microscope Mission Modeling Molecular National Cancer Institute Operative Surgical Procedures Patients Performance Pilot Projects Polyps Population Primary Care Physician Prospective Studies Protein Conformation Proteins Protocols documentation Quality of Care Radiologic Health Reagent Receiver Operating Characteristics Regulatory Affairs Resolution Role Sampling Sensitivity and Specificity Serum Serum Albumin Spatial Distribution Specificity Staging Target Populations Techniques Technology Testing United States Centers for Medicare and Medicaid Services United States Food and Drug Administration adenoma algorithmic methodologies assay development base biobank cancer diagnosis colorectal cancer screening commercialization cost cost effective diagnostic assay experience gastrointestinal improved instrument molecular imaging patient population phase 1 study phenomenological models public health relevance research clinical testing screening spectroscopic imaging

Address Affect African American Algorithmic Software Award Benign Biological Assay Blood specimen Cancerous Chemicals Classification Clinical Clinical Research Collaborations Collection Colonoscopy Colorectal Cancer Comorbidity Controlled Study Detection Diagnosis Diagnostic Discrimination Disease Disease Management Early Diagnosis Evaluation Exhibits Feasibility Studies Fecal occult blood Future Gastroenterologist Goals Health Health Professional Healthcare Human Immunoglobulin G In Vitro Institutional Review Boards Lasers Maps Methodology Methods Microscope Mission Modeling Molecular National Cancer Institute Operative Surgical Procedures Patients Performance Pilot Projects Polyps Population Primary Care Physician Prospective Studies Protein Conformation Proteins Protocols documentation Quality of Care Radiologic Health Reagent Receiver Operating Characteristics Regulatory Affairs Resolution Role Sampling Sensitivity and Specificity Serum Serum Albumin Spatial Distribution Specificity Staging Target Populations Techniques Technology Testing United States Centers for Medicare and Medicaid Services United States Food and Drug Administration adenoma algorithmic methodologies assay development base biobank cancer diagnosis colorectal cancer screening commercialization cost cost effective diagnostic assay experience gastrointestinal improved instrument molecular imaging patient population phase 1 study phenomenological models public health relevance research clinical testing screening spectroscopic imaging

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项目摘要

DESCRIPTION (provided by applicant): ChemImage Corporation, a 2014 Tibbetts Award recipient, in collaboration with GastroIntestinal Associates and the Allegheny Center for Digestive Health, proposes a disruptive technology based on high throughput Raman Molecular Imaging (RMI) spectroscopy for colorectal cancer (CRC) diagnosis called the Raman Assay for Colorectal Cancer (RACC). RMI involves the collection and evaluation of spatially resolved Raman spectra using supervised multivariate statistical analysis (i.e. chemometric) techniques. In preliminary Pilot Studies, RACC has been able to detect subtle changes in dried blood serum composition and protein conformation without the use of chemical reagents. RACC can differentiate between biobanked blood serum samples from patients with colorectal cancer versus those who are disease free with sensitivity and specificity of approximately 90%. Pilot studies conducted to date suggest RACC is sensitive to early stage CRC and the presence of polyps, including advanced adenomas, and if validated as technically and clinically feasible, RACC would have commercial value as a CRC screening in vitro diagnostic (IVD) assay. In this proposed project which is relevant to the mission of the National Cancer Institute, ChemImage anticipates undertaking the first demonstration of the technical and clinical feasibility of RACC applied to fresh clinical blood serum samples. The longer term objective and intended use of the RACC Test will be as an aid in screening patients for pre-cancerous polyps and CRC. The RACC Test will be used by health care professionals who screen for CRC, including gastroenterologists and primary care physicians. In this Phase 1 study, RMI spectroscopy will be performed at low throughput using a Raman microscope operating with 785nm laser excitation without the use of reagents. In its mature commercial form, the RACC Test would be performed on a high throughput RACC instrument enabled by automated detection algorithms and software in =5 min per dried blood serum sample to minimize cost per assay. If validated for Intended Use as a CRC screening assay, we anticipate RACC will undergo Food and Drug Administration (FDA) premarket approval (PMA) and will require Centers for Medicare & Medicaid Services (CMS) National Coverage Decision. ChemImage has assembled a Regulatory Affairs & Reimbursement Advisory Group, with participation of experienced consultants having years of past experience within the FDA, CDRH, Office of IVD & Radiological Health, and CMS, whose goal is to increase the likelihood of successful commercialization. RACC has the potential to provide the detection performance approaching colonoscopy at costs comparable to fecal occult blood tests (FOBT), because it operates without the use of costly reagents. Since RACC would be applicable to blood serum samples, it is anticipated to have a very high compliance rate among target patient populations, and as a result improve the quality of care, and reduce the cost of managing CRC disease. Also of significance, as CRC disproportionally affects African American patients, the successful development of this assay would help reduce this healthcare disparity.

描述（由应用程序提供）：Chemimage Corporation，2014年Tibbetts奖获得者，与胃肠道员工和Allegheny消化健康中心合作，建议基于高吞吐量Raman Molecular Imaking（RMI）光谱的颠覆性技术，用于结肠癌（CRC）诊断型Raman Assay（RACC），RACCCANCAY（RACC）CARCAY（RACC）。 RMI涉及使用监督的多元统计分析（即化学计量学）技术来收集和评估空间分辨的拉曼光谱。在初步的初步研究中，RACC能够检测出血清组成和蛋白质组成的细微变化，而无需使用化学试剂。 RACC可以将结肠直肠癌患者与敏感性和特异性的无疾病患者与大约90％的无疾病区分开。迄今为止进行的试点研究表明，RACC对早期CRC和包括晚期腺瘤在内的息肉的存在敏感，如果在技术和临床上可行的验证，RACC将具有商业价值作为CRC筛查体外诊断（IVD）测定。在这个与国家癌症研究所的使命相关的拟议项目中，Chemimage预计将首次展示RACC的技术和临床可行性，用于新鲜的临床血清样品。 RACC测试的长期目标和预期使用将有助于筛查患者的癌前息肉和CRC。 RACC测试将由筛查CRC的卫生保健专业人员（包括胃肠病医生和初级保健医生）使用。在这一第一阶段的研究中，RMI光谱法将在低吞吐量下使用带有785nm激光兴奋的拉曼显微镜无需使用试剂。在其成熟的商业形式中，RACC测试将通过自动检测算法和软件在每个干血清样品中= 5分钟启用的高吞吐量RACC仪器进行，以最大程度地减少每个测定的成本。如果对预期用作CRC筛查测定法进行了验证，我们预计RACC将接受食品和药品管理局（FDA）上市批准（PMA），并将需要中心进行Medicare＆Medicaid Services（CMS）国家承保范围的决定。 Chemimage已组建了一个监管事务和报销咨询小组，并参与了FDA，CDRH，IVD＆Sadiological Health办公室和CMS的经验顾问的参与，其目标是增加成功商业化的可能性。 RACC有可能以与粪便血液检查（FOBT）相当的成本提供检测性能，因为它在不使用昂贵的试剂的情况下运行。由于RACC适用于血清样品，因此预计目标患者人群的合规率很高，因此可以提高护理质量，并降低管理CRC疾病的成本。同样重要的是，由于CRC不成比例地影响非裔美国人患者，因此该测定法的成功开发将有助于降低这种医疗保健差异。