“Cherish your visions and your dreams as they are the children of your soul, the blueprints of your ultimate achievements.” Napoleon Hill – American Author
Clinical trials, data collection and analysis, and the completion of scientific validation for TBDx™ remain an intensive effort throughout Applied Visual Sciences and a detailed blog update on those activities will be provided next week. Current validation of the TBDx™ diagnostic software reduces the demand for new algorithm development and presents an opportunity to redirect our R&D efforts on the completion of the breast cancer detection product, BCDx™, in expectation of filing for FDA approval before year-end.
We routinely receive requests from shareholders, board members, family and friends to apply BCDx™ to suspect breast studies (mammograms, ultrasounds, and/or MRIs). These studies prove invaluable for our research efforts as they provide suspect cases to test the performance of the technology. Since BCDx™ does not currently have FDA approval for use, and no one on staff is a licensed medical practitioner, we were unable to provide these interested individuals with a BCDx™ diagnostic outcome. What we did provide was a report that included BCDx™ processed images of their mammograms along with information on how to interpret the BCDx™ images. The intent of our report was to provide educational information, in non-medical terms, that the patient could use to better understand their mammogram and to be better educated on the questions they should ask their physician.
Recently we received three cases from women in California, Indiana, and Minnesota. As we have experienced previously, the cases are from women that are uncomfortable about the diagnostic outcome of their breast studies. Further, they express a strong desire to contribute their images to assist in benefiting future generations. Given the developmental stage of BCDx™, we achieve the greatest research benefit from confirmed cases of breast cancer, specifically those cases with multiple years of breast studies. The images received from California provided that level of research value as the woman was diagnosed with breast cancer in July 2014 and had breast studies (mammograms that used the current state-of-art CAD technology and MRIs) dating back to August of 2010.
The moment her 2014 mammogram image appeared on the screen it was immediately visually apparent that she had a significant region of concern that could not be missed by human visual inspection. BCDx™ identified the lesion’s location and visually presented the various stages of the cancer’s development by characterizing the tissue variations within the cancerous lesion. BCDx™ further indicated that the core of the lesion was distinct and large as represented by the yellow color. As we have learned through previous pathology reviews, the yellow color response is indicative of necrotic tissue and directly associated with an advanced case of cancer. The most compelling outcome was that BCDx™ located and identified the cancerous areas in each of the previous breast studies, as far back as August 2010. BCDx™ diagnosed the cancer development four years before radiologists could identify it. This is important because earlier detection leads to longer life expectancy.
The radiologist involved in this woman’s case deployed the currently FDA approved computer-aided-detection (CAD) software to assist in diagnosis. The lack of diagnosis in 2010-2013 clearly illustrates that current CAD systems are not a viable solution for assisting radiologists in identifying breast cancer consistently. CAD places marks at areas of concern, but adds no additional knowledge beyond what the human eye can see. There is no value add to the decision-making process nor is there enhancement in the pathologist’s level of diagnostic confidence. BCDx™ is a more sophisticated and advanced technology that adds knowledge to the decision-making process through enhanced visualization that represents the cancer tissues response to our algorithms. Further intelligence is extracted from the image and presented to the pathologist in the form of quantitative data about the suspect region. Increased knowledge increases diagnostic confidence and reduces missed cases of breast cancer.
We all know people or family members who have been diagnosed with cancer. Some of us have lost family members to complications arising from the disease. If you or someone you know, have been diagnosed with breast cancer, and you would like to assist us in validating the technology – please speak with your doctor about receiving a copy of your breast studies, for as many years as they are available, on a CD. Forward the CD to the following address:
Applied Visual Sciences, Inc. • 525K East Market Street, #116 • Leesburg, VA 20176 • Attn: Tom Ramsay
Please also provide your contact information (preferably an email address) as we may need to contact you for addition information about your case. WE WILL NEVER DISCLOSE YOUR NAME IN ANY OF OUR MATERIALS – YOUR CONFIDENTIALITY IS GUARANTEED. We sincerely appreciate your participation in this effort and will return a written report of our findings for your review. You may find it interesting to see the impact BCDx™ may have had on your case.
Applied Visual Sciences, Inc. is an image analysis software technology company publicly-traded on the OTC Bulletin Board under the trading symbol, APVS. The company has developed intelligent, next-generation imaging analytics and informatics technologies for the extraction, analysis, and detection of objects-of-interest within any digital image format (still or video).