From 2000 to 2005 there has been a 4% decrease in the number of women who are screened for breast cancer, according to the National Cancer Institute (NCI; Bethesda, Maryland). Time, availability and geographical distance are thought to be among the primary roadblocks that prevent women from getting screened for breast cancer.

But what if those barriers could be eradicated? What if mammography screening could be taken to the patient?

GE Healthcare, (Waukesha, Wisconsin), a $17 billion-unit of General Electric (Fairfield, Connecticut), is banking on its mobile Senographe Essential, which is built off of Senographe Full Field Digital Mammography systems, to tear down these road blocks and reach women who in some cases would otherwise go unserved.

The company reported last week that the mobile device has received FDA clearance.

The unit — which is installed in specially configured vans via GE Healthcare’s specific modifications — already has CE mark approval. GE Healthcare has partnered with Medical Coaches (Oneonta, New York), a company that develops mobile screening units, to design the vans housing the Senographe Essential.

With the mobile system, “patients have more comfort and convenience than going to a clinic or a hospital for these tests,” April Dorcas, general manager of X-ray and marketing for GE Healthcare, told Medical Device Daily. “It eliminates that fear of going to the doctor’s office,” which they often do alone, she said. With close access of the mobile system, they will more likely be “with friends or family that act as a support group.”

Mobile full-field digital mammography offers other advantages, Dorcas said. Importantly, besides not requiring women to travel considerable distances, the system offers digital capabilities that allow breast images to be checked by the technologist instantly, to ensure that technique and positioning are correct and that the images going to the radiologist for review are of the highest quality.

“In some cases the images will be transmitted via satellite to a hospital or a lab so someone can read the results and transmit the findings back to the mobile unit,” Dorcas told MDD. And the company says that the system features a digital detector, which delivers the industry’s highest detective quantum efficiency, the standard for quantifying digital X-ray image quality — at low doses.

The mobile platform came about after several countries in Europe urged the need to develop a means of mobile screening. It seemed to flourish in areas where there was a socialized approach toward medicine.

But Dorcas said even more telling was recent NCI statistics. A study published in May 2007 by the NCI found that use of mammography screening had dropped 4% from 2000 to 2005. In 2005, only 70% of women surveyed for the study reported getting an annual mammogram.

During the same timeframe, among women in the 50-64 age group — the group most at risk for breast cancer — screening dropped from 79% to 72%.

According to the American Cancer Society (Atlanta), mammography rates in the State of Washington are also below the national average. In a 2005-2006 study, only 56.3% of women 40 to 64 were screened. The national average during that period was 60.5%.

This startling statistic partly paved the way for Seattle to receive the first of these mobile screening units.

Courtesy of a month-long fund-raising campaign sponsored by the Seattle Division of Safeway and supported by its employees and customers, along with a corporate grant from the Safeway Foundation to acquire a van for the mobile Essential unit, breast-screening clinics will be held at locations around the Seattle region, that state marked by areas lacking nearby mammography services.

“Women living in the state of Washington have higher rates of breast cancer compared to the rest of the country,” said Connie Lehman, MD, and PhD, director of radiology at the Seattle Cancer Alliance. “And yet compared to the rest of the country, we also have fewer women receiving regular screening mammography. We [now] have an opportunity to be screened with the latest technology for early detection of breast cancer.

“This is our way of removing some of the barriers preventing women from having screening mammograms.”

To date this is the only mobile system is in Seattle. But there are plans to have more of these units in operation, she said.

GE Medical’s Senographe 200D, on which the mobile unit is based, was one of four applications — along with the Fischer Imaging (Denver) SenoScan, the Hologic (Bedford, Massachusetts) Lorad, and the Siemens Medical Solutions (Malvern, Pennsylvania) Mammomat Novation — that made it through the FDA regulatory process at a time when other companies had a great deal of trouble receiving 510(k) clearance (MDD, May 25, 2006).

In 2002 the Senographe 2000D was used to screen more than one million women in 20 countries.

GE Healthcare also recently reported forming a partnership with Sprint (Reston, Virginia) to bolster the development of wireless communications in hospitals (MDD, August 15, 2007).

No Comments