Guardian Technologies' novel imaging analysis technology platforms may help avoid mammography false positives

Nov 24 2009

Guardian Technologies International, Inc. (OTCBB: GDTI) -- A recent U.S. Preventive Services Task Force report suggests that while mammograms save lives, they also lead to unnecessary additional procedures. Experts suggest that the problem with mammography is that improvements are needed to reduce false positives and increase accuracy. As mammography has advanced from film-based imaging to digital imaging, the digital images provide greater levels of detail, revealing areas of interest that previously weren't visible -- and containing far more information than the human eye can possibly see or interpret.

While annual mammography is a reliable, cost-effective technology for screening, many mammograms are difficult to interpret and can lead to misreads. Misreads can be categorized into false negatives (failure to identify cancer) and false positives (interpret non-cancer as cancer). The reasons for missed breast cancers on mammograms include cancer existence in dense breast tissue, cancer hidden behind normal anatomic structure, lack of prior comparative mammograms, or failure of the cancer to visualize on the mammogram. Digital mammography has been shown in National Institute of Health-sponsored DMIST clinical trials to be an improvement when compared to screening film in detection and differentiation of cancer in dense breasts. But it can lead to false positives, which cause patient anxiety, and these unnecessary and additional diagnostic procedures may result in increased radiation exposure, complications associated with biopsy and unnecessary financial burdens.

Dr. Randall Brodsky, Radiologist, SMH Radiology Associates, PA, believes that routine mammograms are an important tool in the fight against breast cancer for women, but improvements are needed. "Mammography is a great screening tool, but can be less sensitive in cases such as with dense breasts," Dr. Brodsky stated. "We are seeing more detail in digital images, which frequently leads us to call for further examination. Currently, performing an additional procedure to help make a decision is the right course of action. However, more sophisticated and information-rich software applications that can enhance sensitivity and categorize areas of interest could be very useful in assisting us to make decisions so that we can help eliminate extra views and reduce patient callbacks. Reducing unnecessary procedures is less stressful for patients and assists us to more efficiently use healthcare resources."

Image analysis technologies have not, however, kept pace with the improvements in image quality and have failed to provide the additional information that would enable radiologists to fully interpret all these areas of interest. This leads to more uncertainty in the clinical diagnostic process and often prompts unnecessary costly biopsies or other procedures to rule out breast cancer. Fortunately, Guardian Technologies International, Inc. (OTCBB: GDTI) has developed and independently tested advanced digital imaging analysis technology platforms potentially capable of addressing issues in breast cancer detection. The direct digital imaging systems that are coming online provide the opportunity to use new image processing approaches to extract better information from the imaging data.

"Eliminating routine mammograms for women under 50 is short-sighted. There are better ways to solve the cost and accuracy issues," Dr. Brodsky stated emphatically. "Advances in imaging analysis software show promise to significantly improve screening accuracy -- likely at a much lower cost than additional procedures, such as biopsies, and certainly at a far less human cost than the trauma associated with performing those procedures."

Guardian Technologies believes its Signature Mapping™ image analysis platform, having successfully completed clinical trials in South Africa for tuberculosis diagnosis, and PinPoint™, its independently tested and validated explosives detection software, could be important technological aids in breast cancer detection. Signature Mapping and PinPoint's transformational approach synthesizes new digital information to produce textural, morphological, topological, boundary and gradient features and other values that aid classification of areas of interest within images.

"Signature Mapping extracts unseen, clinically valuable image data from digital images to better visualize, characterize, and identify various clinical materials, such as diseased from non-diseased tissues," said Bill Donovan, Guardian Technologies' President & COO. "We have already undertaken preliminary research and development efforts in the area of mammography. Based on our internal results and observations, we believe Signature Mapping holds the potential to enhance and visualize regions of interest to make mammograms easier for radiologists to interpret. While the technology and early results are promising for mammography, we have primarily focused our limited resources on explosives detection and the diagnosis of TB -- the world's second leading cause of death, with an estimated 2 million deaths annually."

Guardian Technologies recently concluded a successful Phase I clinical trial with the South African Government's National Health Laboratory Services (NHLS). The breakthrough application significantly boosted the efficiency, accuracy, consistency and speed of TB diagnosis, and removes most of the human limitations that currently hamper diagnosis of TB. Guardian has been invited to return for Phase II (final phase) clinical trials in early 2010.