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.
Public Health Relevance Statement: Public Health Relevance: The Raman Assay for Colorectal Cancer (RACC) involves the application of Raman molecular imaging (RMI) spectroscopy to the analysis of blood serum samples. Preliminary results obtained from bio bank samples indicate excellent discrimination performance approaching 90% sensitivity and specificity for the detection of colorectal cancer (CRC), but technical feasibility for application to fresh clinical samples needs to be established. If successful, RACC will be optimized in a high throughput configuration to provide a cost- effective in vitro diagnostics capability that will improve the quality of care in CRC screening an disease management.
Project Terms: Address; adenoma; Affect; African American; algorithmic methodologies; Algorithmic Software; assay development; Award; base; Benign; biobank; Biological Assay; Blood specimen; cancer diagnosis; Cancerous; Chemicals; Classification; Clinical; Clinical Research; Collaborations; Collection; Colonoscopy; Colorectal Cancer; colorectal cancer screening; commercialization; Comorbidity; Controlled Study; cost; cost effective; Detection; Diagnosis; Diagnostic; Discrimination (Psychology); Disease; Disease Management; Early Diagnosis; Evaluation; Exhibits; experience; Feasibility Studies; Fecal occult blood; Future; Gastroenterologist; gastrointestinal; Goals; Health; Health Professional; Healthcare; Human; Immunoglobulin G; improved; In Vitro; Institutional Review Boards; instrument; Lasers; Maps; Methodology; Methods; Microscope; Mission; Modeling; Molecular; molecular imaging; National Cancer Institute; Operative Surgical Procedures; patient population; Patients; Performance; phase 1 study; Pilot Projects; Polyps; Population; Primary Care Physician; Prospective Studies; Protein Conformation; Proteins; Protocols documentation; public health relevance; Quality of Care; Radiologic Health; Reagent; Receiver Operating Characteristics; Regulatory Affairs; research clinical testing; Resolution; Role; Sampling; screening; Sensitivity and Specificity; Serum; Serum Albumin; Spatial Distribution; Specificity; Spectrum Analysis; Staging; Target Populations; Techniques; Technology; Testing; United States Centers for Medicare and Medicaid Services; United States Food and Drug Administration
