The teaming agreement is an ideal collaboration of health care organisations, specialized corporate technologies and clinical information for this proposal. The team includes experienced clinical, technical and managerial personnel from all three institutions.
"Not only are we honored to be partnering with Howard and USC, we believe that this is also a major validation of our own next generation technology and its ability to potentially help millions of women suffering from breast cancer", stated Michael Trudnak, Chairman and Chief Executive Officer of Guardian Technologies International. "We look forward to this collaboration and believe that ultimately it is a sign of many more positive events to come for our shareholders."
Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among women in the United States. Mammography is a reliable and cost-effective technology, when properly conducted it has been estimated to reduce breast cancer mortality by 20-30 percent. Until Guardian's Signature Mapping software solution, reading mammograms was difficult and prone to interpretation subjectivity and misreads.
"The future of medicine lies in the delivery of sophisticated imaging techniques and technologies that provide doctors with enhanced visualization and detection capabilities to more accurately diagnose disease states and substantially reduce misdiagnosis", stated Michael Trudnak. "The early successes we have experienced with Signature Mapping moved the timeline forward to create this subsidiary to concentrate our commercialization efforts and maximize shareholder value."
Signature Mapping is an advanced analysis and visualization technology that can be seamlessly installed to read images from any medical imaging device, including MRIs, CT-scans and X-rays, to detect disease states in the brain, lungs, heart, prostate and can even visualize breast cancer in difficult to distinguish dense breast tissue.
Recently, Guardian announced the successful completion of a pivotal test that showed Signature Mapping achieved a 97,5 percent detection rate or sensitivity on cancer cases, with just 2,5 percent false negatives or cancer lesions undetected. These results are particular promising given that current mammography procedures yield an 80 percent accuracy rate, leading to more than 1 million unnecessary biopsies each year.
Signature Mapping is protected by a robust patent portfolio. Guardian has already undertaken research, development and clinical evaluation on challenges ranging from more precise and earlier detection of breast and prostate cancer. Research has also proven that Signature Mapping can automatically detect intracranial haemorrhagic associated with traumatic brain injuries using CTs, and can locate and quantify multiple sclerosis lesions in MRIs, as well as the extent of tuberculosis, pneumoconiosis, and even cancer in the lungs using commonly available and inexpensive chest X-rays.
The new grant, when completed, will create a one-of-a-kind African-American longitudinal mammography knowledge database including all screening and diagnostic mammography images, radiology and pathology reports for each normal and cancer patient; the database will be expanded from 260 to 1, 300 patients which will include both normal and confirmed cancer patients.
The objective of the grant, which is expected to be bestowed by December 2007, is to save or prolong the lives of African-American Women (AAW) who develop breast cancer. To accomplish this objective the team will validate Signature Mapping with Howard's longitudinal mammography knowledge base of AAW. The plan includes delivery of the first prototype of a visualization tool to aid in breast cancer detection 18 months after project initiation. The development of an enhanced, easy-to-use mammographic detection methodology is an additional goal and with additional large-scale testing, the technology can be moved into clinical use.
Furthermore, the programme will develop a predictive model which will forecast the likely onset of cancer for asymptomatic patients. This model will provide a powerful clinical tool enabling accurate and timely prediction of onset and progression of the disease. The success of this predictive model would provide a powerful tool to implement African-American oriented, breast cancer imaging research.
The impact of Guardian's industry-first computer-aided detection technologies are immediate and profound for helping to eliminate human error in both the Homeland Security and the Medical Industry sectors. The company's software solutions can be seamlessly installed to compliment existing imaging devices, such as baggage scanners and medical MRI, to scan the contents of any image and immediately identify items of interest not easily discernable by the human eye.
Guardian's technology compliments and enhances current-generation baggage X-ray scanners with the ability to automatically and effectively detect, locate, and identify explosives and other types of threats.
Existing medical imaging devices used in Computer Aided Detection (CAD) are further improved with Guardian's auto-diagnostic ability to detect anomalous tissue (e.g., tumours) and other potential disease states or conditions.
Because Guardian's technologies utilize and process the actual image output generated by the original imaging systems, virtually any existing or future imaging device can be upgraded with Guardian's products, delivering an instant, multi-billion dollar potential customer base with no competition.
Guardian's technology and product development partnerships include a Co-operative Research and Development Agreement (CRDA) with the United States Department of Homeland Security - Science and Technology Directorate. The company's platform and product suite is protected by a robust patent portfolio. They are also ramping up new technologies and plan to acquire complimentary technologies to accelerate the company's high-growth business model. More company news can be found in the VMW May 2007 article Confirma Inc. and Guardian Technologies International Inc. sign collaboration and strategic alliance agreement.