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

• 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
• 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

 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（由申请人提供）：ChemImage Corporation是2014年Tibbetts奖的获得者，与胃肠协会和Allegheny消化健康中心合作，提出了一种基于高通量拉曼分子成像（RMI）光谱用于结直肠癌（CRC）诊断的颠覆性技术，称为结直肠癌拉曼分析（RACC）。RMI涉及使用监督多元统计分析（即化学计量学）技术收集和评估空间分辨拉曼光谱。在初步的初步研究中，RACC已经能够在不使用化学试剂的情况下检测干血清组成和蛋白质构象的细微变化。RACC可以区分来自结直肠癌患者的生物库血清样本与无疾病的患者，灵敏度和特异性约为90%。迄今为止进行的初步研究表明，RACC对早期CRC和息肉（包括晚期腺瘤）的存在敏感，如果经验证技术和临床可行，RACC将具有作为CRC筛查体外诊断（IVD）试验的商业价值。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应用于新鲜临床血清样本的技术和临床可行性。RACC测试的长期目标和预期用途将有助于筛查癌前息肉和CRC患者。RACC测试将用于筛查CRC的医疗保健专业人员，包括胃肠病学家和初级保健医生。在本1期研究中，将使用拉曼显微镜在低通量下进行RMI光谱分析，该显微镜采用785 nm激光激发，不使用试剂。在其成熟的商业形式中，RACC测试将在高通量RACC仪器上进行，该仪器通过自动化检测算法和软件实现，每个干燥血清样品在=5分钟内进行，以最大限度地降低每次测定的成本。如果作为CRC筛查检测的预期用途得到验证，我们预计RACC将接受美国食品药品监督管理局（FDA）的上市前批准（PMA），并将需要医疗保险和医疗补助服务中心（CMS）的全国覆盖决定。ChemImage组建了一个法规事务和报销咨询小组，由在FDA、CDRH、IVD和放射卫生办公室以及CMS拥有多年经验的经验丰富的顾问参与，其目标是增加成功商业化的可能性。RACC有可能提供接近结肠镜检查的检测性能，其成本与粪便潜血试验（FOBT）相当，因为它不使用昂贵的试剂。由于RACC将适用于血清样本，因此预计在目标患者人群中具有非常高的依从率，从而提高护理质量，并降低管理CRC疾病的成本。同样重要的是，由于CRC对非裔美国人患者有预防性影响，这种检测方法的成功开发将有助于减少这种医疗保健差异。