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iCAD Initiates Clinical Study of its Virtual Colonoscopy CAD
June 24, 2008
by Barbara Kram, Editor
NASHUA, NH -- iCAD, Inc., an industry-leading provider of Computer-Aided Detection (CAD) solutions for the early identification of cancer, has initiated a clinical study for Colon CAD, its virtual colonoscopy CAD product, in partnership with ACR Image Metrix, a subsidiary of the American College of Radiology (ACR). iCAD and ACR Image Metrix, having completed the development portion of the study, are collaborating on study execution including a multi-reader, multi-case (MRMC) clinical study designed to assess the impact of Colon CAD on the accuracy of interpreting CT Colonography exams also known as virtual colonoscopies. The study will also assess the sensitivity of Colon CAD for detecting polyps and will measure the impact of iCAD's CT Colon CAD product on interpretation and workflow.
Virtual colonoscopy offers patients a less invasive option to conventional colonic polyp detection techniques. Reviewing these images can be tedious and challenging because of the amount of information captured in a CT exam. iCAD's colon CAD product uses sophisticated image processing analysis technology to identify polyps in images with the potential for streamlining the reading process and improving accuracy, productivity and workflow. The study, which will be managed and executed by ACR Image Metrix, will include up to 20 radiologists, is expected to take about six months to complete and will include the analysis of several hundred cases tested with virtual colonoscopy featuring Colon CAD.
"Moving to this clinical study, which should enable iCAD to submit the necessary data to the FDA, is an exciting step bringing the Company closer to taking our Colon CAD product to market," said Ken Ferry, President and Chief Executive Officer of iCAD. "Working with ACR Image Metrix, a group with a high level of expertise in this area, will be of great value in helping us prove the tremendous benefits we believe our Colon CAD product can provide both in polyp detection and workflow enhancement. We believe our Colon CAD product has tremendous market opportunity and will be a great addition to our established CAD product lines for breast cancer detection."
Although 140,000 people in the U.S. will be diagnosed with colon cancer this year, it is one of the most preventable cancers when early polyps are detected and removed. More than 82 million Americans are over 50 years of age, thus making them eligible for colorectal cancer screening; however, diagnostics are significantly underutilized, due at least in part to the invasive nature of current screening procedures such as colonoscopy. Results from recent trials including the National CTC Trial conducted by the ACR Imaging Network (ACRIN) that demonstrated the effectiveness of virtual colonoscopy as a screening procedure, coupled with recent initiatives to establish Medicare reimbursement for the procedure, may increase the viability of virtual colonoscopy for colorectal cancer screening and are likely to drive increased utilization of the procedure.
"CT Colonography will not only provide a new and necessary option for cancer detection, but has the potential to increase screening rates nationwide," said Abraham Dachman, M.D., Professor of Radiology, University of Chicago Medical Center and Principal Investigator of the Colon CAD study. "While we expect the benefits in polyp detection will be significant, we are also exploring how enhanced workflow features can add to the benefit CAD provides to CT Colonography."
About ACR Image Metrix
ACR Image Metrix is a subsidiary of the American College of Radiology ACR, the premier professional society serving more than 32,000 radiologists committed to ensuring that imaging is safe, effective, and accessible to all patients. ACR Image Metrix is based on the successes of ACRIN®, the NCI-funded clinical trials cooperative group established in 1999 to assess emerging imaging technologies. ACRIN®'s clinical trials have involved as few as 65 to more than 50,000 subjects and have handled over 50 million images. The ACRIN® portfolio includes such high-profile studies as the Digital Mammographic Imaging Screening Trial (DMIST) and the National Lung Cancer Screening Trial (NLST).
About iCAD, Inc.
iCAD, Inc. is an industry-leading provider of Computer-Aided Detection (CAD) solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, upgradeable CAD systems for the high, mid and low volume mammography markets. iCAD is entrusted with the task of early cancer detection by over 2,000 women's healthcare centers worldwide. For more
information, visit www. http://www.icadmed.com
Virtual colonoscopy offers patients a less invasive option to conventional colonic polyp detection techniques. Reviewing these images can be tedious and challenging because of the amount of information captured in a CT exam. iCAD's colon CAD product uses sophisticated image processing analysis technology to identify polyps in images with the potential for streamlining the reading process and improving accuracy, productivity and workflow. The study, which will be managed and executed by ACR Image Metrix, will include up to 20 radiologists, is expected to take about six months to complete and will include the analysis of several hundred cases tested with virtual colonoscopy featuring Colon CAD.
"Moving to this clinical study, which should enable iCAD to submit the necessary data to the FDA, is an exciting step bringing the Company closer to taking our Colon CAD product to market," said Ken Ferry, President and Chief Executive Officer of iCAD. "Working with ACR Image Metrix, a group with a high level of expertise in this area, will be of great value in helping us prove the tremendous benefits we believe our Colon CAD product can provide both in polyp detection and workflow enhancement. We believe our Colon CAD product has tremendous market opportunity and will be a great addition to our established CAD product lines for breast cancer detection."
Although 140,000 people in the U.S. will be diagnosed with colon cancer this year, it is one of the most preventable cancers when early polyps are detected and removed. More than 82 million Americans are over 50 years of age, thus making them eligible for colorectal cancer screening; however, diagnostics are significantly underutilized, due at least in part to the invasive nature of current screening procedures such as colonoscopy. Results from recent trials including the National CTC Trial conducted by the ACR Imaging Network (ACRIN) that demonstrated the effectiveness of virtual colonoscopy as a screening procedure, coupled with recent initiatives to establish Medicare reimbursement for the procedure, may increase the viability of virtual colonoscopy for colorectal cancer screening and are likely to drive increased utilization of the procedure.
"CT Colonography will not only provide a new and necessary option for cancer detection, but has the potential to increase screening rates nationwide," said Abraham Dachman, M.D., Professor of Radiology, University of Chicago Medical Center and Principal Investigator of the Colon CAD study. "While we expect the benefits in polyp detection will be significant, we are also exploring how enhanced workflow features can add to the benefit CAD provides to CT Colonography."
About ACR Image Metrix
ACR Image Metrix is a subsidiary of the American College of Radiology ACR, the premier professional society serving more than 32,000 radiologists committed to ensuring that imaging is safe, effective, and accessible to all patients. ACR Image Metrix is based on the successes of ACRIN®, the NCI-funded clinical trials cooperative group established in 1999 to assess emerging imaging technologies. ACRIN®'s clinical trials have involved as few as 65 to more than 50,000 subjects and have handled over 50 million images. The ACRIN® portfolio includes such high-profile studies as the Digital Mammographic Imaging Screening Trial (DMIST) and the National Lung Cancer Screening Trial (NLST).
About iCAD, Inc.
iCAD, Inc. is an industry-leading provider of Computer-Aided Detection (CAD) solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, upgradeable CAD systems for the high, mid and low volume mammography markets. iCAD is entrusted with the task of early cancer detection by over 2,000 women's healthcare centers worldwide. For more
information, visit www. http://www.icadmed.com