Hologic, Inc. (Bedford, MA) was founded in 1986 with a bone densitometer as its first product. Today, the international company employs nearly 750 people and develops, manufactures, and distributes a variety of products. The company is very involved in women's health, and its product lines include osteoporosis assessment, conventional and digital mammography, breast biopsy, direct-to-digital X-ray for general radiography applications, and mini C-arm imaging for orthopedic applications.

In July 2001, Jack W. Cumming was appointed Chief Executive Officer. He was named Chairman of the Board in November 2002. He spoke with Applied Radiology about changing technologies and how they affect women's health imaging.

Applied Radiology : How has the migration to digital changed the practice of radiology?

Jack Cumming: We throw around words like the digital revolution and the migration to digital with PACS, but it took a long time for some of these modalities to be totally accepted and to proliferate. Today, PACS has only penetrated approximately 15% of the market, but it will be a billion dollar business in the not-too-distant future. Digital radiography--of which Hologic was a pioneer--and digital mammography are the last outposts of analog that have now migrated to digital.

Through technologic innovation, we're going to find more cost-effective, better ways to check different disease states. The interventional pathways will be able to be mapped better with the use of new contrast agents and new algorithms that allow surgical planning. As an example, in breast cancer detection, magnetic resonance (MR) imaging certainly helps in evaluating the disease--such as where it has spread and the size of it--which helps to guide surgeons in lumpectomies and other treatment elements.

A digital world, nanotechnology--it's all going to happen. A decade from now, I think we're going to see some significant differences. Hopefully it's going to increase the life that you and I have.

AR: How will such technologies help prolong life?

Cumming: At radiology shows today, you can see 16-slice computed tomography (CT), the combination of positron-emission tomography (PET) and CT, and digital mammography. We're migrating. Our Selenia is not a revolutionary product; it's an evolutionary product. It's obvious that the world is going to go to digital. With that, I think we are going to see a big increase in our ability to diagnose. It's the treatment regimens, the pharmaceuticals, the true bio-markers, the targeting agents, and cancer drugs that we are going to see; these are the improvements that are really going to prolong life.
Cardiovascular diseases and cancer are the two leading causes of death, and that is where people are putting their money in research.

AR: What is the most important issue in women's imaging today?

Cumming: I think it's the use of the data. From my perspective--and I'd like to think I'm speaking for the company--we are firm believers in developing and designing technology that is screening technology.

With the advent of digital, there has been a big push to increase reimbursement for digital mammography. Although I favor increased reimbursement, my focus has been on increasing reimbursement for screening exams because we need to be able to serve a broader population of people. Without increased reimbursement for screening, we are going to find a continual decrease in the number of mammography centers and a continual decrease in the number of trained mammographers and technicians who serve that market.

Other than that, certain enhancements or adjunctive technology will help to better prioritize decision making because, obviously, the better road leads to better outcomes. We still have to look at the number of people in the population and ask, How do we serve them better? How do we get them involved? How do we educate them to get imaged on a regular basis so that we can catch this disease early enough because the survival rates are significantly higher if caught early?

AR: What are the benefits of digital versus conventional mammography?

Cumming: From a workflow standpoint, there is no doubt that you can improve patient throughput. Now, I want to be careful when I say that because I'm not encouraging institutions to change the way that they treat their patients. Breast centers, on the whole, have given patients a lot of TLC because of the high anxiety associated with this exam. Because of that, if you are going to go from imaging 4 patients an hour to 6 or 8 patients an hour--I think some of our competitors are saying that you can do 10--the question is, are you still going to be able to give the kind of TLC to the patients that earns the reputation of that breast center? That concerns me.

That being said, it will change who the patient interfaces with. Will they spend more of that TLC time with a different caregiver, such as a backup technologist? The woman gets to the scanner and that procedure will take less time because a tech does not have to go out and see if the images are OK, they are just going to show up on the screen. You're going to get better patient care just because there is less wait time, fewer retakes, and the images will be electronically stored in PACS. At our Selenia workstations, you are able to view not only the mammogram, but if there is an MRI or an ultrasound taken of the breast, all of that added information will be resident on the hospital PACS or the management information system that we sell as a solution.

The promise of digital is better resolution. In a sense, we've delivered that. If you look at the Pre-Market Approval (PMA) data from all the companies, digital has basically shown an equivalency to film. But the promise has been that it's going to be better than film, and we believe that Selenia certainly speaks directly to that challenge.

AR: Hologic began with bone densitometry. Tell me about the Discovery Bone Densitometer.

Cumming: The Discovery is also an evolutionary product; it has taken scanning and interpretation to a new level. We can image the hip or the spine within 10 seconds. Plus, it has a CT-like design so that it can perform instant vertebral assessments.

We can do the bone scan in 10 seconds, and then we can do the scan of the spine in 10 seconds. We have automated analysis tools including computer-aided detection (CAD) for fracture grading. We have electronic reporting and full integration capabilities with hospital information systems. This allows you to streamline the workflow with what we call OnePass technology. It's a proven technology platform and a true fan-beam technology.

AR: How does the CAD feature work in fracture grading?

Cumming: The CAD tools quantify the degree of vertebral compression and provide the data in a very simple format: the image of the spine with highlighted areas. It takes the physician right down the spine at the monitor; it takes each area and indicates whether it is normal or if it needs further examination. It's either going to classify the section of spine as normal or as a previous fracture and, therefore, in need of treatment for osteoporosis. The physician at that point might decide to perform a CT scan or an MR study to clearly show the problem area.

AR: How would you get more women to undergo this important examination?

Cumming: I think it will have to come from the pharmaceutical companies. They have done a very good job to date, but they need to do a better job. They're spending tens of millions of dollars to promote their pharmaceuticals, and in that education process, as part of their ads, they say, Have you had a bone scan done? What's your T-score? They are targeting primary care physicians, of course, because that is who will prescribe their products, especially in light of the recent negative press on hormone replacement therapy. With these recent studies, it becomes more important for physicians to add drug therapy with an agent such as bisphosphonate or selective estrogen receptor modulator.

Our funds are spent more on the technology side. We have pamphlets and brochures that the doctors can give to their patients. We try to work with the pharmaceutical companies and with the different societies to help promote this. It's very troubling because I have not seen hospitals go mainstream with this. It's troubling as the son of a mother who had a hip fracture, not as somebody who happens to be running a company that manufactures this product.

I was visiting a customer who had 15 of our mammography systems and I asked them if they had bone densitometry and they said yes. So I said, I didn't see it in the women's center. They went around the room. The first person said, I think it's in endocrinology. The next person said, No, I think it's in orthopedics, and another said, No, I think it's now in radiology. I said, Why don't you have it in the women's center where you do mammography? You have a captive population there. The majority of patients are postmenopausal. They are the targets here. If it's a matter of economics, you get $200 reimbursement. Everybody complains about mammography and how grossly inadequate reimbursement is--and it is, especially with centers closing. Yet here you get $200 versus the approximately $80 you get for screening mammography; and the exam takes 30 seconds.

Each year 60,000 people die from osteoporosis-related injuries. It's staggering. The prevalence of breast cancer is so high that it becomes very personal, but with osteoporosis we just haven't been able to get it there yet. I wish I had the answer.

AR: What is the company philosophy at Hologic?

Cumming: One thing that I am very proud of here is that if you go through our facilities, we have survivors of breast cancer in our mammography side of the company. We have relatives of people who haven't survived. They certainly could find jobs closer to their homes, they might even be able to find jobs that pay them more money, I don't know. But they are not in it for the number of systems that we manufacture each month, each year. They're really in it because they truly believe that they are making a difference in people's lives with our technology.

If you talk to the people on the bone densitometry side, they are as passionate as the people on the mammography side. That is nice to see; that altruism actually works. From a philosophical standpoint, if the company operates on the basis of trying to develop and commercialize technologies that make a difference in people's lives, then the benefits will accrue to them and to their shareholders.