Establishing Clinical Feasibility of the Raman Assay for Colorectal Cancer

DESCRIPTION provided by applicant ChemImage Corporation a 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 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 study RMI spectroscopy will be performed at low throughput using a Raman microscope operating with nm 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 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 andamp Medicaid Services CMS National Coverage Decision ChemImage has assembled a Regulatory Affairs andamp Reimbursement Advisory Group with participation of experienced consultants having years of past experience within the FDA CDRH Office of IVD andamp 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 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 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