Radiation-Free Breast Cancer Detection Device

Currently, mammography is the only FDA-approved independent breast cancer screening method — but it has its limitations, and may be ineffective for women with dense breasts — about 25% of women. In addition to being uncomfortable for women, it misses from 15 to 20 percent of breast cancer cases despite conversion to digital mammograms, according to the U.S. National Cancer Institute.

A new device uses measurements of tissue elasticity for breast cancer detection, useful for diagnosis in women with dense breasts, typically Asian and younger women, for whom imaging procedures that rely on differences in tissue density are more challenging.

A better method of breast cancer detection may be on the way. A new device developed at Drexel University (Philadelphia, PA) aims to enable more accurate breast cancer screening and cancer detection in populations where mammography is not widely available or accurate — including women in developing countries, and those under the age of 40.

Dr. Wan Shih, Dr. Wei-Heng Shih, and their team developed the device, which was selected to receive a $200,000 award through the University City Science Center’s QED Program in its inaugural cycle in the fall of 2009. Shih’s project is the second QED-funded project to be licensed. Her team was assisted by QED Business Advisor Susan Maley.

The project also received support from the Wallace H. Coulter Translational Research Program at Drexel University. The QED Program is the first multi-institutional proof-of-concept program for life sciences technologies. It bridges the “valley of death” — the gap between academic research and commercial development — by providing scientists with guidance from experienced regional entrepreneurs, feedback from regional investors and funding to demonstrate proof of concept.

How it Works

The non-invasive, radiation-free screening device utilizes a handheld probe comprising piezoelectric finger (PEF) sensors that can detect very small forces and displacements at the surface. These are converted to electrical signals to determine the elastic modulus or shear modulus, which serve as a precise indicator of tissue stiffness in compression or in shear. Simultaneous measurement of both shear and compression stiffness in the underlying breast tissue enables detection of very small tumors, and also differentiation of cancers from non-cancerous lumps.

This device may be especially important for women with denser breasts, such as Asian and younger women, for whom imaging procedures that rely on differences in tissue density are more challenging. The device provides an especially sensitive reading of abnormal breast mass. The sensors can also identify masses that are typically too small for detection by other screening devices. For example, mammography can only detect masses larger than 10 mm, while the PEF is able to detect abnormalities as small as 2.5 mm in size.

The device could also enable breast cancer screening and diagnosis in populations where mammography is not widely available, or where it may serve as an adjunct to mammography for women with dense breast tissue where the procedure has decreased utility.

Where it Stands

The technology has been licensed by UE LifeSciences, a Philadelphia-based medical device company. The product will be called Intelligent Breast Exam™ (iBE™). “The technology’s potential to enhance the clinical breast exam while maintaining high specificity can be key in further empowering the women’s health provider community,” explained UE LifeSciences CEO Mihir Shah. “We are also interested in leveraging the technology’s ability to provide noninvasive malignancy assessment; we envision market potential in developing regions and primary health centers around the world.”