DOTmed caught up with Hologic director of marketing, Jim Culley, Ph.D., at the 2009 AHRA Annual Meeting and Exhibition to talk about emerging technologies and the company's role in women's health.

As of Aug. 1, there were 8,711 certified sites across the country providing mammography services according to the FDA's monthly Mammography Quality Standards Act (MQSA) scorecard. About 54 percent of the sites had gone digital -- up from 40 percent a year ago, said Culley.

"We seem to be doing a lot of things right," noted Culley. "U.S. industry shipment data shows that Hologic enjoyed over 65 percent of all digital mammography (DR and CR) sales in the first half of 2009 -- a new record for us. NEMA (National Electrical Manufacturers Association) data show that analog mammography shipments have almost disappeared. Less than 5 percent of the mammography systems sold in the U.S. 2008 were analog."

In the past few months, Hologic has introduced a number of new products to the company's portfolio of women's health products, including the automated Quantra breast density assessment software.

"It creates an internal 3D model of the breast from which it derives estimates of the fibro glandular tissue volume and total breast volume; volumetric breast density is the ratio of these values," explained Culley. "Using the Quantra tool to provide numeric values for each breast may aid radiologists in the assessment of breast tissue composition without the subjectivity of human interpretation."

The company recently released DigitalNow HD, the only FDA-cleared application for processing and comparing digitized screen-film mammograms.

Hologic also just introduced three new Selenia digital mammography products in the U.S. including their Selenia Dimensions 2D system, and the Selenia Dimensions 2D FFDM, which can be configured for 3D breast imaging, also known as tomosynthesis, when and if the 3-D technology is approved by the FDA.

"Digital Breast tomosynthesis is a three-dimensional imaging technology that involves the acquisition of a series of low-dose images at different angles across a stationary compressed breast," explained Culley. "The individual images are then reconstructed into a series of thin high-resolution slices that can be displayed individually or in a dynamic cine mode. This separation of tissue into virtual layers helps the physician clearly see features which might be obscured in a traditional two-dimensional mammogram."

Hologic breast tomosynthesis showed distinct improvement in clinical accuracy according to clinical trials, which also showed "dramatic gains in specificity -- the confidence to rule out cancer without recalling the patient for further study," stated Culley.

Hologic's tomosynthesis system was the first on the market and has been installed in Europe for nearly a year. Culley noted that tomosynthesis has been talked about for many years but only recently did it become commercially viable to produce. Advances in processing and reconstruction algorithms have a lot to do with its new-found feasibility.

"Two years ago it took more than an hour of heavy-duty compression processing to get one image reconstructed," said Culley. "Now we can do it in a couple of seconds."

In addition, Hologic's SecurView workstations provide R2 computer-aided detection (CAD), a sophisticated tool that can help clinicians detect cancer at its earliest stage, noted Culley.

Hologic also offers the MammoPad breast cushion, a soft foam pad designed to help minimize discomfort and to enable technologists to get the best possible image during a mammography screening. It's not just a simple pad.

"You don't want anything to show up in that X-ray image, so you've got to have a radiolucent cushion. That's not easy to do," said Culley. "The MammoPad has a lot of technology behind it."

Unfortunately it is not reimbursed by CMS, but a lot of customers have picked up on it and some are even offering it as an inexpensive self-pay option to patients.

"If a suspicious lesion is detected, Hologic supports the next clinical steps," stated Culley. "Hologic ATEC, Eviva and Celero breast biopsy systems, coupled with their MultiCare Platinum prone biopsy table and StereoLoc II upright biopsy platform, are designed to facilitate highly precise, image-guided procedures under minimally invasive conditions and provide compassionate care for every woman facing a breast cancer diagnosis."

In the case that early-stage cancer is detected, many women could be candidates for Hologic's MammoSite five-day targeted radiation therapy system, which offers a patient-friendly alternative to traditional whole breast radiation.

"Our focus and concentration on breast cancer is unparalleled," Culley said. "No other major healthcare company devotes a higher percentage of its resources to the development and deployment of screening, diagnostic and therapeutic technologies to meet the diverse challenges of this disease. As a result, breast surgeons, radiation oncologists, and related healthcare professionals alike have come to rely on our continued advancements in digital mammography, biopsy technologies, and radiation-focused breast conservation therapy."

Established in 1985 and with centers of operation in North America, Europe, Central America, Australia and Asia, Culley said Hologic is focused on extending its medical systems and solutions to benefit women around the world.

The company's products span nine areas of women's health, including mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia (excessive periods), permanent contraception, osteoporosis assessment, preterm birth risk assessment and mini C-arms for extremity imaging, as well as molecular diagnostic products, including human papillomavirus (HPV) testing and reagents for a variety of DNA and RNA analysis applications.

"We have the strength and resources of a billion dollar company, along with the vision of leaders committed to a broad spectrum of women's health issues," Culley said. "Our nearly 4,000 employees are personally dedicated to achieving breakthroughs in research, product development and the worldwide distribution of healthcare solutions. And we have the unwavering partnerships of thousands of healthcare professionals who match our dedication to extending and enriching the lives of women everywhere."