Skin Cancer Detection Device Offers Diagnostic Accuracy, Helps Reduce Biopsies
VANCOUVER, BRITISH COLUMBIA--(Marketwire - Jan. 23, 2012) - Verisante Technology, Inc. (TSX VENTURE:VRS)(OTCQX:VRSEF)(PINKSHEETS:VRSEF)(FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, today announced the results of the statistical analysis completed by the University of British Columbia ("UBC") on data from a clinical study in which the Verisante Aura was used.
The 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.
In the study, measurements on over 1,000 lesions were acquired from 848 patients. The analysis presented here is focused specifically on malignant melanoma, squamous cell carcinoma, basal cell carcinoma, actinic keratosis, and benign conditions that can visually mimic skin cancer. The final dataset thus consisted of 518 validated lesions from 453 subjects. The results of the analysis showed that Aura had a sensitivity of 99% with a specificity of 17% in differentiating all major skin cancers from benign lesions. At a sensitivity of 95%, Aura's specificity increased to 41%. For melanoma versus benign lesions, Aura had a sensitivity of 99% with a specificity of 15%. At a sensitivity of 95%, specificity increased to 38%.
The FDA has previously required an endpoint sensitivity of 95% for a device that detects melanoma. An earlier Australian study that found that the clinical diagnosis of skin cancers and pre-cancers was associated with a sensitivity of 63.9% for basal cell carcinoma, 41.1% for squamous cell carcinoma, and 33.8% for malignant melanoma.
"Real-time Raman spectroscopy can distinguish malignant from benign skin lesions with strong diagnostic accuracy when compared to clinical examinations and other optical-based methods," said Dr. Harvey Lui, MD, FRCPC, Director of the Skin Care Centre at Vancouver General Hospital, Dermatologic Oncologist at the BC Cancer Agency, Professor and Head, Department of Dermatology and Skin Science, UBC, and one of the inventors of the Aura. "The results demonstrate the benefits of using the Aura as an objective tool to assist medical professionals in diagnosing skin cancer."
Dr. Haishan Zeng, senior scientist in the Integrative Oncology Department (Imaging Unit) at the BC Cancer Agency and Associate Professor of Dermatology and Skin Science at UBC, presented the results and analysis as an invited keynote speaker on January 22, 2012 at SPIE, an international society advancing an interdisciplinary approach to the science and application of light. The analysis notes numerous studies show a dramatic range of biopsy ratios to rule out melanoma. An Australian study estimated that if all atypical pigmented lesions were to be biopsied to rule out melanoma, the biopsy ratio would be as high as 200:1. Using the Verisante Aura, the biopsy ratio for cancerous versus benign lesions is 1.03 biopsies for each cancerous lesion found.
"Our evaluation of the statistical analysis by UBC is that the Aura will save lives and save money," said Thomas Braun, President and CEO, Verisante. "Even using the most rigorous statistical methods, the results indicate that using the Aura to assist in guiding clinical evaluations could potentially reduce the number of unnecessary biopsies by 50% to 100%. These clinical results show that Aura will make a statistically significant difference in the detection of skin cancer and will support our marketing and distribution efforts in Canada, Europe and Australia. There are over 22,000 dermatologists and over half a million general practitioners in these markets."
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% and it costs about $1,800 to treat it. In the late stages, the survival rate decreases to 15%, while the cost to treat it increases to $170,000.
Approved for sale in Canada, Europe and Australia, Verisante Aura™ is indicated for use for the evaluation of skin lesions that may be clinically suspicious for melanoma, squamous cell carcinoma and/or basal cell carcinoma 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 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.
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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