The only approved FDA breast cancer screening system in the U.S. is mammography beginning at age 40 for women. The main issue is the effectiveness of the screening device is often substantially lessened in women with dense breast tissue. The mammogram also provides little to no information on the stiffness or mobility of a tumor and has a sensitivity level of 85% but in dense tissue breasts that decreases to 65%.

Researchers at Drexel University (Philadelphia) are vying to bring their developed breast cancer detector to market, a device which could overcome the limitations of a mammogram and provide a portable and radiation free alternative to the clunky devices.

The detector is based on piezoelectric fingers, an elastic and shear modulus sensor developed at the university.

The proposed screening tool will be positioned as an early breast cancer test to be used by physicians and gynecologists in the clinical setting in conjunction with the physical examination. It supplements mammography to screen early for breast cancer in women with dense-tissue breasts.

"We have been working of this for quite a long time," Wan Shih, PhD, a breast cancer survivor and an associate professor in Drexel's School of Biomedical Engineering, Science and Health Systems told Medical Device Daily. "I envisioned this device in the early 2000's. The device was not originally intended to detect breast cancer. I was envisioning a device that could measure the elasticity of tissue."

But five years into the program Shih changed the focus of the device and geared it more toward detecting breast cancer, a disease which she survived.

Shih said that the PEF device is comprised of a hand-held probe with small electrical measurement units that can be operated by a laptop computer.

Here are some highlights of the device:

Palpation-like tissue stiffness imaging both under shear and under compression with less than one-millimeter spatial resolution up to a depth of several centimeters.

Use of the shear modulus/elastic modulus ratio to measure tumor mobility to screen for malignancy.

It has demonstrated more than 90% correlation between the shear/elastic modulus ratio and tumor malignancy – a capability all existing technologies lack.

With a single or double 1.5 cm wide PEF of depth sensitivity of 3 or 6 cm, it can probe for breast cancer for almost all body types.

Patients are in a supine position which poses no discomfort.

The PEF is gentle. It only works with less than 1% strain, which would cause minimal discomfort to the patient.

Researchers are also saying that there are cost benefits for using the device as a pre-screening system. The portable system much would be much cheaper and require fewer operators than ultrasound, MRI and nuclear medicine tests.

Plans call for Shih to make bid for the device to be commercialized and seek FDA clearance.

"There are several entrepreneurs talking with us about licensing the technology," she said. "As for FDA approval right now we're planning on having clinical trials in India and China. And the reason we want to go in to those places is because there are a higher percentage of women with dense breast tissue in China than in the U.S."

Ultimately the goal is to have a calculator-size electrical measuring unit and a less than a less than 5" x 5" x 5" 3-D automation unit to operate the PEF. This imaging tool will help the physician locate smaller breast tumors than the current technologies and screen for tumor malignancy at the same time to save lives.

As to when the device would actually hit the market, Shih said it would be realistic to think that we could see it in clinics in about five years.

Shih added, "It's really not complicated. It's not radioactive and it's very friendly to the human body."

Omar Ford, 404-262-5546;