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Volume 1 • Issue 3 • July 2008 Coming Together? The Pathology–Radiology Paradigm E. Blair Holladay, PhD, SCT(ASCP)CM By E. Blair Holladay, PhD, SCT(ASCP)CM I s the novel idea of merging the practices of radiology and pathology gaining momentum? Experts in medical imaging, molecular diagnostics, radiology, and advanced informatics convened in February at the Molecular Summit in Philadelphia (www.molecular-summit.com/presentations. htm) to share their perspectives on the prospect of a new paradigm—a blended diagnostic department delivering total health assessment quickly, cost-effectively, and conveniently. Some predict that alignment of these practices will move health care a step further on the path of personalized medicine. Already, fine needle aspiration programs are merging with radiological services to establish a more integrated approach to tumor diagnostics. Current monitoring of drug treatment efficacy (e.g., cytochrome p450) is another example of this enhanced paradigm. In the not-too-distant future, integrated molecular assays and arrays will help establish better sensitivity and specificity of disease and a “one-stop shopping” report for the clinical appraisal. This new age of total integration diagnostics will require collaboration across laboratory medicine, pathology, and radiology, according to Bruce Freidman, MD, Emeritus Professor of Pathology at the University of Michigan Medical School, Ann Arbor, Michigan. Concerned Parties 16 Friedman identified several groups that may resist the movement. Health care providers, for one, may fear that this new prototype will add significant cost to a sector already struggling to pay for even routinely diagnosed diseases. The FDA’s interest in controlling the use of in vitro diagnostic multivariate index assays may impede the future model of a total diagnostics, he said. Physicians and other health care practitioners may be anxious because they are trained to diagnose disease based on existing patient symptoms, not on anticipated patient problems. Academic pathology departments also are unlikely to initially support such a divergent practice paradigm [the lion’s share of their activities are still focused on clinical or translational research activities], particularly due to the risk averse and conservative nature of academic practitioners, according to Jared Schwartz, MD. However, he added, the clinical imperative by the patient may eventually force a re-evaluation of the current “silo” departmental academic system. Dr. Schwartz is Director of Pathology and Laboratory Medicine at Presbyterian Hospital in Charlotte, North Carolina, and the current President of the College of American Pathologists. New subspecialty practice paradigms will have to be developed, with practices based on specific organ diagnostics or disease class diagnostics. Residency programs will have to support the evolving prototype of an integrated diagnostic practitioner with the ultimate goal of producing a timelier, more accurate, and less expensive result. Under this paradigm, such practitioners would interpret imaging, biopsies, and molecular in situ biomarker panels as well as direct ancillary imaging studies to help clinicians determine the most appropriate therapeutic drug modality for the individual patient. Ultimately, the consumer will most likely force this systematic change. Patients are frustrated by the current approach of piecemeal diagnostics and the often contradictory results used to establish their disease state. The integrated model of total diagnostics is driven not by symptomatology but by total health surveillance using preemptive evaluative services intended to thwart future disease. With the Early Health Model, pathology and laboratory medicine take the lead in this paradigm, because molecular diagnostics serve as the first step for determining presymptomatic disease. “Wellness” biomarkers, periodically performed to optimize health screening, would transform the annual physical from a symptomatology-based experience (in part) to a surveillance exercise. This paradigm will require robust laboratory information systems, Friedman noted. Blended diagnostic departments would require an integrated IT infrastructure with synergy across radiology, pathology, and laboratory medicine. This would be necessary to prevent the “swallowing” of diagnostic data by inadequate electronic medical records. Future Considerations In the future, molecular imaging will likely involve the use of novel biomarker probes to recognize in vivo targets, which in turn allow for greater quantitative analysis of the specific disease state. Nanotechnology, defined in this case as the use of in situ biomarkers or radiotracers, shifts the focus of diagnostics from the mere identification of a lesion to the art of total discovery. King Li, MD, Professor, Weill Cornell Medical College, New York City, and MD Anderson Distinguished Chair, Department of Radiology at the Methodist Hospital, Houston, Texas, described the current environment of diagnostic medicine as simply diagnosis and treatment. He envisions the revised paradigm to be quite different within two years (2010)—predisposition of disease is followed by focused screening, early detection, individualized treatment, and eventually therapeutic monitoring. The one-size-fits-all theory of diagnosis and treatment clearly ignores the genetic diversity of humans. As a result, the innovative field of interventional radiology is emerging as a vehicle for delivering molecular and functional imaging. It does so by guiding interventional molecular therapy with nanoscale particles targeted to visualize, target, and treat disease in vivo. This creates a seamless approach to diagnosis and treatment (including appropriate therapeutics). An integrated system would include an effective monitoring scheme for the evaluation of the patient’s disease. Amazing, but not unrealistic: Nanoparticles are being designed for complete diagnosis and treatment of disease. The future of “Star Trek” medicine is in fact a reality, most likely coming to a hospital near you. Dr. Holladay is Vice President for Scientific Activities for ASCP and Executive Director of the ASCP Board of Registry, Chicago, IL. 17