UltraClinics: Same-day Cancer Diagnosis in Search of a Market

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Build a better mousetrap and they’ll beat a path to your door—or will they? UltraClinics, Inc, is a company prepared to offer same-day interpretation of breast-biopsy tissue and, if needed, teleoncology consultation for women undergoing breast-cancer screening. Its processes and technologies have been patented and trademarked; they can be applied to other procedures, such as prostrate-cancer screening. UltraClinics has allied itself with large corporations like IBM and has even purchased its own pathology recruiting service to find staff for its proposed clinics. For all this, more than a year after its unveiling, its actual operation is confined to two clinics affiliated with the University of Arizona. The patients that it serves number a handful per day. UltraClinics, for now, is an example of the inertia that can strike medical advances—not because the core ideas don’t work, but because the health care delivery apparatus isn’t designed or prepared to support them. The irony is that while UltraClinics sits more or less motionless, its founder is almost certainly correct when he says that what the company offers is a model for how medicine will be practiced, perhaps in the near future. Ronald S. Weinstein, MD, founder and chair of UltraClinics, is a cancer pathologist trained at Tufts University who did his residency at Massachusetts General Hospital. Weinstein says that he coined the term telepathology, along with inventing the first robotic telepathology system in the mid-1980s. He says, “The first patent on telepathology was issued to me. The very first patent is my patent. It is a solo-authored patent.” Weinstein successfully demonstrated his system in a 1986 feed between El Paso, Tex, and Washington, DC, proving, he says, that pathology could be done working from a video monitor. In 1990, Weinstein moved to the University of Arizona College of Medicine in Tucson, where he oversaw the development of the Arizona Telemedicine Program (ATP), of which he is still the director. He is also a professor and chair of the school’s pathology department. By 1998, ATP had evolved into a model telemedicine program that now links 65 specialty physicians with 171 sites and 71 communities in or adjacent to Arizona. More than 250,000 patients have been served through the network, including patients on the state’s Native American reservations and in its prisons. About 65,000 telemammograms have been done. “We’re number one in the country,” Weinstein says. He notes that grants to ATP exceed $25 million. One of those grants was to develop a mobile trailer that could house a digital mammography unit. It was the mammography unit that got Weinstein pointed toward what would become UltraClinics. Over and over, he says, the chief complaint that he heard from women who had to undergo a breast biopsy after a positive mammogram was the waiting that they had to endure before they knew, a month or more later, whether they had cancer. For most of them, the biopsy results would indicate benign growths, but they still had to endure the long wait; a month is a long time to wait if you think that the outcome may be life changing. Weinstein set himself the goal of cutting down that waiting time. He already had the telemedicine network in place to complete the mammography and get a quick interpretation from a radiologist anywhere on the network. If a breast biopsy was called for, an interventional radiologist or a surgeon could do that the same day that the woman got her mammogram. For most patients, the time bottleneck was the pathology report: How could the tissue be prepared and analyzed while the woman was still at the clinic? With his background in telepathology, Weinstein was well prepared to look for an answer. He only had to look across campus. Inventing a Virtual Slide Scanner By happenstance, the University of Arizona is a world leader in the study of optics. Because the air is clear around Tucson, according to Weinstein, 25% of the research done at the university is in optics. The place has even been dubbed Optics Valley. “There are three Nobels in optics over there,” Weinstein says. “They came up with the idea of an optical chip. That ended up as the DMetrix.” The DMetrix was the final piece that allowed the UltraClinics concept of same-day cancer diagnosis to become a reality. The Dmetrix, for which Weinstein says that he played the role of initiating inventor, is a virtual slide scanner that uses an array microscope to turn tissue samples into digital slides that can be interpreted using a video monitor. DMetrix is not legally tied to UltraClinics, but there is cross-ownership through Weinstein and other colleagues, as well as through the university. The DMetrix microscope and rapid scanner have won praise, and DMetrix appears to be on a faster development track than the UltraClinics concept that launched it. Weinstein says that a key technology for the DMetrix came from work he did years before on biological structures called gap junctions. “I realized you could take that and make an optical machine by increasing it to six orders of magnitude,” he says. The optics experts came up with the microscope’s design based on his input, he adds. A more detailed discussion of the DMetrix scanner and the UltraClinics concept is available at www.research.ibm.com/journal/sj/461/weinstein.html. While other virtual slide scanners exist, Weinstein says that the DMetrix is the world’s fastest. It can scan a tissue sample and generate a virtual slide in 1 to 2 minutes, generating up to 12 gigabytes of data. With the DMetrix operational, Weinstein’s vision of a same-day breast cancer diagnostic process entered the world of reality. The same process is now being applied to the diagnosis of prostate cancer, and it could be used to initiate treatment quickly for other cancers and conditions as well, Weinstein says. Implementing the Clinics Gail Barker, PhD, MBA, a long-time colleague of Weinstein’s, is codirector for administration and finance of the Arizona Telemedicine Program. She is also president of UltraClinics, Inc. Like Weinstein and a number of academic colleagues at Arizona, Barker holds a financial stake in UltraClinics. All the UltraClinics investors, however, could say the same thing that Weinstein says: “I still work; I’m not rich.” At present, Barker says, the single full-scale UltraClinic operates at the Tucson Breast Center in the University Medical Center. A second UltraClinic is run by the medical school through its University Physicians Healthcare (UPH) Hospital at Kino Campus, Tucson, but that UltraClinic is not up to speed to the degree that the unit at the breast center is, Barker says. With the hardware and software in place, the UltraClinic breast-examination process, as Barker describes it, is simple. A positive mammogram leads to a decision to do a biopsy, which leads to the interpretation of a virtual slide of the tissue; this lets the woman know, with reasonable certainty, whether she has a malignant growth. From there, the patient, if there is cancer present, can opt for a teleconference with a surgeon or an oncologist about her best treatment options. As Weinstein points out, a second-opinion pathology interpretation is done for all biopsies. If everything goes smoothly, all this takes place in a day. The patient arrives for a mammogram in the morning and, in the worst-case scenario, leaves that evening with a cancer-treatment outline. The telemedicine network means that radiologists and pathologists anywhere on the system can do their respective interpretations according to who is available to work within the single-day time limit. “The big achievement,” Weinstein says, “is to be able to tell people rapidly they’re OK. They don’t have cancer.” Barker says that the UltraClinic at the breast center has served as a proof-of-concept model. The bugs are out of the system now, but along the way, major lessons have been learned, she adds. Within the breast center, she says, the UltraClinic patients have to be handled within the overall flow of all the work being done there. “If it’s not part of the regular clinic work flow, people won’t use it,” she says. “Even in freestanding clinics, it has to be where patients are being seen for other things.” Within a breast-imaging center where only mammograms and biopsies were done, an UltraClinic could exist as a stand-alone process, she adds. “On a larger scale, these patients are triaged. We’re just at the tip of the iceberg with the UltraClinic.” Another key to meeting the 1-day diagnosis goal is to get the patients in early. A biopsy needs to be done in the morning. “If you get tissue specimens at 4 PM, you’re not going to make it the same day, so there has to be a champion (of the process) at the institution,” Barker says. Can the speed with which a cancer diagnosis is made in an UltraClinic save lives? As with so much else about the process, it’s too new to have been documented, but Barker says she thinks that it does save lives, or at least prevent onerous cancer treatments. “This is my belief. You could have, traditionally, 30 days from a mammogram to a positive tissue finding. Some of the more aggressive cancers could advance in those 30 days,” she says. Barker says that she and Weinstein worried, in the beginning, that patients might be overwhelmed by the intensity of the 1-day process, especially when it was capped by a teleconference with an oncologist. She says, “Is this too much information for a patient to receive in a day? Do they need time to process all this? The answer was no. They want to know and they want to get on with their lives. They don’t mind the teleconferencing.” Time as Money With DMetrix ultra-rapid scanners and microscopes installed at key locations in a large health care enterprise, tissue samples could be taken and scanned and then could be interpreted by pathologists at any location. This is already done on a limited scale in Tucson; Barker says, “The pathologist doesn’t have to be in physical proximity to the slide.” Besides expedited diagnosis, another promise of the UltraClinics process is increased patient volumes. Barker says, “The real value is the increase in volume.” Despite that assessment, she can’t yet cite figures. “I don’t know the volume numbers,” she says. “It’s more than in the traditional setting.” She also says, without giving figures, that the UltraClinic at the breast center is profitable due to the increase in volume. On the other hand, Weinstein estimates that the number of patients going through the UltraClinic per day is only two or three. He says, so far, that about 400 patients have been served through the UltraClinics. Clearly, at the breast center, UltraClinic is simply a process available within the broader setting. It hasn’t been used in a stand-alone way to demonstrate its own financial validation. Barker says, however, that it’s not only profitable, but that downstream revenue is generated when patients with cancer are referred for treatment within the medical center or the UPH complex. This could be expanded beyond breast and prostate cancers. “Anything you would take a tissue sample of could be done this way,” she says. Barker also says that most of the reimbursement issues have been dealt with, although sometimes “not through normal channels.” The teleconferencing piece must meet special billing regulations, she adds, yet it’s all feasible. While no return on investment has been computed on the equipment in Arizona, an UltraClinic wouldn’t cost much to initiate, Barker says. The key additional equipment, the DMetrix microscope and the rapid scanner, she estimates, might cost in the neighborhood of $200,000. “It’s insignificant in the hospital environment,” she says. As the concept was unveiled, the UltraClinics model was seen as a fast, cutting-edge way to use telehealth to expedite diagnosis and initiate treatment for breast and other cancers. A thousand mini-clinics were predicted. Arrangements were entered into with IBM to use its servers and with EPO International, a health care brokerage company that UltraClinics acquired, to recruit staff as needed. UltraClinics, as a company, was to license member facilities to use its processes. So far, that hasn’t happened. “We haven’t done a very good job of getting the word out,” Barker says. Another impediment may be the acknowledged need for a large-scale information infrastructure to handle the huge volumes of telemedicine and telepathology data. Barker says that other facilities in Arizona that have seen the UltraClinics have shown interest, but an agreement with the university not to expand locally beyond its two hospitals has prevented those installations. “We’re still searching for the right business model,” Weinstein says. “We have urgency, but we’re all extremely busy.” He predicts that the implementation driver will probably be consumer demand. “UltraClinics is dependent on patient-driven health care and patients having a health care account,” he says. “That is the carrot for us, and we’re trying to design a business model that will thrive in that environment. You can’t do that in the current insurance-driven model because of the fragmentation of health care services.” He continues, “It’s a very big issue. The people behind UltraClinics like to believe—and probably pray for—the day when consumer-driven health care is available on a wide basis. That’s necessary if we’re going to bundle these services.” In the meantime, Weinstein adds, UltraClinics is ready to consult with any facility that wants to offer patients these services. “We have a consulting business on the roll-out of UltraClinics. That’s what UltraClinics currently is. It’s available now.” It might be a great little mousetrap, just waiting for someone to drop in the cheese.