Results Conclusively Demonstrate the Non-Invasive Skin Cancer Detector's Diagnostic Accuracy and Potential for Reducing Unnecessary Biopsies
VANCOUVER, BRITISH COLUMBIA--(Marketwire -03/20/12)- Verisante Technology, Inc. (TSX-V: VRS.V - News)(OTCQX: VRSEF.PK - News)(Pinksheets: VRSEF.PK - News)(Frankfurt: V3T.F - News) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that the results of the statistical analysis completed by researchers at Vancouver General Hospital ("VGH"), the BC Cancer Agency ("BCCA"), and the University of British Columbia ("UBC") on data from a clinical study of the Verisante Aura™, have been accepted for publication by Cancer Research, a peer reviewed journal of the American Association of Cancer Research ("AACR").
The paper, titled Real-time Raman spectroscopy for in vivo skin cancer diagnosis, was co-authored by Drs. Harvey Lui, Jianhao Zhao, David McLean and Haishan Zeng. The Company previously announced the preliminary results of the analysis in January this year to coincide with the invited presentation by Dr. Haishan Zeng, distinguished scientist in the Integrative Oncology Department (Imaging Unit) at the BCCA and associate professor of dermatology and skin science at UBC, at SPIE, an international society advancing an interdisciplinary approach to the science and application of light. "It is an honour to be accepted for publication in Cancer Research," said Dr. Harvey Lui, director of the Skin Care Centre at VGH, dermatologic oncologist at the BCCA, professor and head, Department of Dermatology and Skin Science, UBC, and one of the inventors of the Aura™. "This study clearly demonstrates that the Verisante Aura™ has significant diagnostic accuracy in distinguishing malignant from benign skin lesions and offers the potential for reducing unnecessary biopsies by 50 per cent to 100 per cent. An additional advantage of using Aura™ as an objective tool to assist medical professionals in diagnosing skin cancer is that the device requires less extensive user training and expertise than other traditional diagnostic approaches."
Skin cancer is currently diagnosed based on visual examination by a clinician, followed by a biopsy of suspicious lesions. Previous research has shown that the accuracy of clinicians in correctly diagnosing skin cancer is highly variable and dependent upon the level of formal training and experience of the clinician. Biopsy ratios (the number of non-melanoma lesions that undergo biopsy for each confirmed melanoma) can range from 58:1 to 21:1, for new versus experienced general practitioners, and could be as high as 200:1 if all atypical pigmented lesions were to be biopsied to rule out melanoma.
The study shows that when using Verisante Aura™ to diagnose melanoma versus benign pigmented lesions at a sensitivity of 99 per cent and a specificity of 15 per cent, the biopsy ratio would be 5.6:1. At a sensitivity of 95 per cent and a specificity of 44 per cent, the biopsy ratio could decrease to 3.8:1. When using Aura™ to diagnose skin cancer and pre-cancerous lesions versus benign lesions, at a sensitivity of 99 per cent and a specificity of 17 per cent, Aura™ has a biopsy ratio of 1.03:1, and with a sensitivity of 90 percent and a specificity of 68 per cent, the biopsy ratio can be as low as 2.3:1.
"The results of the clinical study data analysis, when compared to clinical diagnostic accuracy and biopsy ratios, demonstrate the effectiveness of the Aura™ to serve a large unmet need," said Thomas Braun, President & CEO, Verisante Technology, Inc. "This clearly suggests that Verisante Aura™ offers a statistically significant improvement in the detection of skin cancer. We look forward to sharing the full study data with doctors in Canada, Europe and Australia, where Aura™ is approved for sale, as we move forward towards full production and sales in the second half of 2012."
Early detection is key to saving the lives of melanoma patients and saving healthcare costs. When melanoma is diagnosed and treated in the earliest stages, the survival rate is 99 per cent and it costs about $1,800 to treat it. In the late stages, the survival rate decreases to 15 per cent, while the cost to treat it increases to $170,000.
Verisante Aura™ is a non-invasive optical system designed as a tool to aid medical professionals in the assessment of suspect skin lesions for diagnosis as either skin cancer or a benign disorder. It uses Raman spectroscopy to biochemically analyze the skin, providing immediate results.
Aura™ is indicated for use for the evaluation of skin lesions that may be clinically suspicious for melanoma, squamous cell carcinoma, basal cell carcinoma, and/or actinic keratosis when a medical professional chooses to obtain additional information to rule out one of the above conditions before making a final decision to biopsy. The device will help to automate the current process of diagnosis, allowing rapid scanning of the 20 to 40 skin lesions on at-risk individuals, improving patient outcomes and comfort.
About Cancer Research
Cancer Research is the most frequently cited cancer journal in the world. The journal publishes original studies, reviews, and opinion pieces offering significance and broad impact to a diverse audience spanning basic, preclinical, clinical, prevention and epidemiological research. Cancer Research seeks manuscripts that offer pathobiological and translational impact to inform the personal, clinical, and societal problems posed by cancer. The main scope of the journal is captured in its primary subsections, which focus on molecular and cellular pathobiology, tumor and stem cell biology, therapeutics and targets, microenvironment and immunology, prevention and epidemiology, and integrated systems and technology.
About the American Association of Cancer Research
The American Association of Cancer Research (AACR) was founded in 1907 by a group of 11 physicians and scientists interested in research, "to further the investigation and spread the knowledge of cancer." Today, the AACR accelerates progress toward the prevention and cure of cancer by promoting research, education, communication, and collaboration. It is the oldest and largest scientific organization in the world that focuses on every aspect of high-quality, innovative cancer research and its reputation for scientific breadth and excellence attract the premier researchers in the field.
About Verisante Technology, Inc.
Verisante is a medical device company committed to commercializing innovative systems for the early detection of cancer. The Verisante Aura™ for skin cancer detection and the Verisante Core™ series for lung, colon and cervical cancer detection utilize a proprietary cancer detection platform while the operating software and probe technology are unique to each device. The cancer detection platform was developed by the BC Cancer Agency and tested and refined at the Skin Care Centre at Vancouver General Hospital. This exclusive platform technology allows Verisante to develop and offer a range of compact, non-invasive cancer detection devices that offer physicians immediate results for many of the most common cancers. The Aura™ has been approved for sale in Canada, Europe and Australia. The Core™ has not yet been approved for sale.
Verisante Aura™ was recently awarded Popular Science Magazine's "Best of What's New Award" for 2011, and Verisante Core™ was named one of the top 10 cancer breakthroughs of 2011 by the Canadian Cancer Society. In addition, the Company was named a finalist for the 2011 Regional Awards for New Technology by the Canadian Manufacturers & Exporters and the National Research Council of Canada and named as the year's top ranking Technology and Life Sciences Company on the TSX Venture 50.
Forward Looking Statements
This release contains forward-looking statements, including, but not limited to, statements regarding the future commercialization of medical devices, the market demand for these products and the proprietary protections the Company will obtain with regard to the technology, all of which statements are subject to market risks, and the possibility that the Company will not be able to obtain patent protection or obtain sufficient customer demand. These statements are made based upon current expectations and actual results may differ from those projected due to a number of risks and uncertainties.
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