Chicago, Dec. 3 /PRNewswire/ -- Medicsight PLC, an industry leader in and principal developer of Computer-Aided Detection (CAD) and medical image analysis software today announced clinical results from a new study that demonstrated CAD significantly increased the sensitivity of readers in the detection of colorectal cancers in multi-row detector CT (MDCT) colonography (CTC). The results also demonstrate that when both expert and non-expert CTC readers used CAD, it increased their sensitivity in detecting and diagnosing colorectal cancers. Medicsight presented data from this study and from additional abstracts that demonstrate the clinical relevance of CAD in early detection and diagnosis of colon cancer at the 94th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) being held through December 5, 2008 in Chicago, IL, USA.
The study (Abstract # SSM10-06: Colorectal Cancers: Effect of Computer-aided Detection in Multirow Detector CT-Colonography - [December 3, 3:50 PM CST]), conducted in Beijing, China, included 60 patients previously diagnosed with colorectal cancers. The patient data was retrospectively reviewed, first without CAD and then with CAD, by four radiologists (two expert and two non-expert radiologists) blinded to colonography and pathology findings. Results showed that CAD increased the sensitivity of expert readers from 80% to 93% (P=0.01) and 97% (P=0.007), and the sensitivity of non-expert readers from 73% and 67% to 90% (P=0.008, P=0.001), respectively.
Medicsight has recently submitted its application for 510(k) clearance to the U.S. Food and Drug Administration (FDA) for its product, ColonCAD(TM), an advanced CAD algorithm used to analyze CT scans of the colon and automatically highlight suspicious areas that may be indicators of disease.
"ColonCAD is fast becoming one of the most clinically validated software applications in medical imaging today," said David Sumner, Chief Executive Officer of Medicsight PLC. "Based on our predicted growth in 2009 across all key markets, we feel confident that ColonCAD will stay on the fast track of image analysis software development. Based on average regulatory review timelines, Medicsight is anticipating an FDA decision on granting clearance for distribution early 2009. If granted clearance, widespread adoption of ColonCAD in the U.S. would be another tremendous step towards decreasing the rate of colon cancer deaths globally."
More than 60,000 medical and science professionals from around the world attending this year's RSNA can see demonstrations of Medicsight's ColonCAD software integrated into their partners' 3D advanced visualization workstations at the company's exhibition stand #4076 (South Building, Hall A).
Additional new data being released at the meeting from studies using Medicsight's ColonCAD will be presented on the following dates and time:
The Medicsight ColonCAD software automatically highlights suspicious areas on computerized tomography scans of the colon, helping radiologists to identify, measure and analyze potential disease and early indicators of disease. Medicsight's CAD software has been validated using one of the world's largest and most population diverse databases of verified patient CT scan data.
CT colonography offers a safe, rapid and minimally invasive means of imaging the entire colon. Medicsight's ColonCAD software works by automatically highlighting suspicious lesions on CTC scans, thereby detecting possible malignant tumors at an earlier stage when treatment is more likely to be successful.
Medicsight has already gained regulatory approval for marketing its ColonCAD software product in Europe, Canada, Australia, China and Brazil. Medicsight anticipates ColonCAD will become available for clinical use in Japan by end of 2008 and the U.S., pending clearance by the FDA, during the first half of 2009. The CAD software will be made available through Medicsight's partners: Vital Images Inc, Viatronix Inc, TeraRecon Inc, Barco N.V., 3mensio Medical Imaging B.V., and INFINITT Co., Ltd. In addition, Medicsight recently announced a new global partnership with Ziosoft Inc, a leading developer of 3D advanced visualization and analysis technology and will be collaborating to distribute combined Ziosoft-Medicsight products for the detection of colorectal polyps through the Ziosoft network.
The clinical effectiveness of CTC in the U.S. was demonstrated by data published in the New England Journal of Medicine in August 2008 from the National U.S. Computerized Tomography (CT) Colonography Trial (ACRIN study 6664). The study showed CT-Colonography had comparable effectiveness to optical colonoscopy in detecting colonic polyps or cancers of 10mm and larger. In addition, the American Cancer Society earlier this year endorsed CTC in its updated screening guidelines, evidence that the clinical value of CTC as a screening technique for colorectal cancer is gaining further clinical relevance and acceptance.
About Computer-Aided Detection (CAD)
With increasingly sophisticated radiological imaging hardware such as Multi-Detector CT scanners, radiologists are facing a growing challenge in the amount of detailed patient image data that they must review for each patient examination. Some CT scan examinations generate as many as 2000 images per patient. Review of this data by the radiologist is not only time-consuming but also prone to error due to reader fatigue. CAD software can help the reviewing radiologist by analysing the image data and automatically highlighting suspicious regions of interest for closer inspection. Without CAD software some potential abnormalities or areas of disease may be overlooked. This can be critical for diagnosis and the management of patient outcomes as early detection of disease greatly increases the probability of successful treatment and a positive therapeutic outcome. In addition to supporting individual radiologists CAD also has the potential to help standardise CT interpretation across both individuals and institutions thereby supporting population based screening programmes.
About Medicsight's CAD software
Medicsight's ColonCAD(TM) and LungCAD(TM) software use an advanced CAD algorithm to analyze CT scans of the colon and lung and automatically highlight suspicious areas that may be indicators of disease. CAD may highlight areas easily overlooked by the reviewing radiologist, such as small lesions or regions that are hidden from view behind folds in the colon or normal structures and surrounding tissue in the lung.
Both CAD products seamlessly integrate with the advanced 3D visualization platforms of industry-leading imaging equipment partners. The integrated systems provide sophisticated image viewing capabilities, including 3D reconstructed image data, with the added advantage of demonstrating automatic CAD findings to assist clinical end users in the detection and analysis of disease. This allows clinical end users to perform either a 'second read', where CAD findings are displayed to the user after completion of an initial review of the CT scan data, or a 'concurrent read' where CAD findings are displayed during the user's initial review of the original CT scan images.
Since inception, Medicsight has developed close and lasting relationships with some of the world's foremost clinicians in product related areas. This provides the Company with a wealth of clinical expertise and dedicated clinical research to support ongoing product development. Medicsight also collaborates with a number of leading academic institutions and clinical research programs worldwide to develop the Company's comprehensive database of population diverse verified patient CT scan data, thus allowing Medicsight's products to be validated to the highest possible standards.
Medicsight PLC is a UK-headquartered, research driven, leading developer of computer-aided detection (CAD) and image analysis software for the medical imaging market. The CAD software automatically highlights suspicious areas on computerized tomography (CT) scans of the colon and lung, helping radiologists to identify, measure and analyze potential disease and early indicators of disease. Medicsight's CAD software has been validated using one of the world's largest and most population diverse databases of verified patient CT scan data. Medicsight's ColonCAD(TM) and LungCAD(TM) software products are seamlessly integrated with the advanced 3D visualization workstations of several industry-leading imaging equipment partners.
For more information about Medicsight, please visit www.medicsight.com.
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Certain statements contained in this News Release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence, increased competition, customer concentration and other risks detailed in the Company's other filings with the Securities and Exchange Commission. The words "believe", "demonstrate", "intend", "expect", "estimate", "anticipate", "likely", and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release.
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