The National Cancer Institute, part of the National Institutes of Health (NIH), has awarded a research grant (R43CA189585) to ChemImage Corporation to develop a blood test using its innovative technology based on high throughput Raman Molecular Imaging (RMI) spectroscopy for colorectal cancer (CRC) diagnosis called the Raman Assay for Colorectal Cancer (RACC). The intended use of the RACC Test will be as an aid in screening, follow-up and diagnosis of patients for pre-cancerous polyps and colorectal cancer (CRC).
Scientists at ChemImage, in collaboration with Dr. Bergein Overholt of GastroIntestinal Associates (Knoxville, TN) and Dr. Paul Lebovitz of the Allegheny Health Network Center for Digestive Health (Pittsburgh, PA), anticipate undertaking the first demonstration of the technical feasibility of RACC applied to fresh clinical samples. The RACC Test, which is performed by collecting Raman Molecular images on dried blood serum samples, will provide clinical results to health care professionals who screen patients for CRC, including gastroenterologists, internal medicine and primary care physicians, once the RACC Test is validated and has received regulatory approvals.
"I am honored to collaborate with the team at ChemImage as we work to establish the clinical feasibility of RACC. The NIH grant is an important part of this work as it will allow us to make strides in our research for early detection of colorectal disease. We hope early detection through usage of the RACC Test will lead to improved patient outcomes in the future," said Dr. Overholt. In addition, Dr. Lebovitz said,"We have made great strides in detecting and treating colon cancer, but our gold standard of colonoscopy continues to be invasive and expensive. The work at ChemImage offers an opportunity to change the face of screening for colon cancer and moving to a time where we reach screening rates never seen before related to this preventative cancer. We are quite excited at the Allegheny Health Network to work on the trials with RACC and colon cancer screening and we believe we will see great success in the future."
In Pilot Studies, the RACC test has been able to detect subtle changes in dried blood serum composition and protein conformation without the use of chemical reagents. The RACC test has been shown to differentiate between bio-banked blood serum samples from patients with colorectal cancer versus those who are disease free with high sensitivity and specificity. 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 feasible RACC could have commercial value as a CRC screening in vitro diagnostic (IVD) assay.
"RACC has the potential to drive better utilization of colonoscopy if it continues to prove to have excellent detection performance at costs comparable to fecal occult blood tests, because it operates without the use of costly reagents," remarked Patrick J. Treado, Founder and Chief Technology Officer at ChemImage. "Because 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 colorectal disease."
If validated for the Intended Use as a CRC screening assay, RACC is expected in the future to undergo the Food and Drug Administration (FDA) premarket approval (PMA) process and will require approval from the Centers for Medicare & Medicaid Services (CMS) National Coverage Decision. ChemImage has assembled a Regulatory Affairs & Reimbursement Advisory Group, with participation of experienced consultants to guide this process. Overall, the company's Scientific Team, Clinical Advisory Board, Regulatory Affairs & Reimbursement Advisory Group are working to enhance the likelihood of successful clinical validation and commercialization.
For more information regarding ChemImage's Raman Molecular Imaging capabilities or the RACC project, contact Patrick Treado at treado[.]chemimage.com.
ChemImage Corporation (chemimage.com), a leader in hyperspectral and Raman chemical imaging technology provides innovative instrumentation, analysis software, contract services and expert consulting to government, industrial and academic organizations. The company's proprietary, state-of-the-art imaging technology has many applications, including defense, security, pharmaceuticals, forensics and biomedical diagnostic research, which can reveal critical chemical and biological information from a variety of material systems.
ChemImage's headquarters are located in Pittsburgh, PA, where it pioneers research and development, as well as providing engineering and manufacturing which develops innovative products for the global marketplace.