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Pathology in the Era of Personalized Medicine


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-09-01-2013
Volume 0
Issue 0

With their knowledge of molecular genetics, Pathologists are transforming the way healthcare is provided.

In its present form, healthcare is largely reactionary. The limited knowledge of the external factors that lead to various diseases has led to a "one-size-fits-all" approach to care. But personalized medicine, the idea of tailoring treatment of a patient based on his or her unique physiological characteristics, is poised to change the practice of medicine. It will allow healthcare providers to detect susceptibility to disease and potentially preempt or prevent disease progression by considering genetic and environmental factors that may increase predisposition.

Pathologists will have an integral role in this new era of care. Personalized medicine relies on new methods of molecular analysis to determine predilection toward certain diseases, but also the likelihood of a certain treatment's efficacy. Relying on these types of precision diagnostics makes the pathologist more visible to physician colleagues, says Gene Siegal, MD, Robert W. Mowry endowed professor of pathology and director of the Division of Anatomic Pathology at the University of Alabama at Birmingham (UAB). Siegal is also the executive vice-chair of Pathology in the UAB Health System, and a member of the American Society for Clinical Pathology (ASCP) Board of Directors.

"Pathologists are absolutely critical to companion diagnostics," said Siegal. "Companion diagnostic tests reside in the lab. Pathologists have total familiarity with the tests and they are best able to report test results to the clinician who is providing the therapy to the patient."

Pathology and the future of personalized medicine

James L. Wisecarver, MD, medical director for Clinical Laboratories at The Nebraska Medical Center (TNMC), where he is also the director of both the Histocompatability Laboratory and the Human DNA Identification Laboratory, said pathologists have been making personalized diagnostic interpretations for decades.

"Pathologists follow new therapies. We've been doing that for many years," Wisecarver said. "Pathologists have to stay familiar with new therapies and learn about certain genetic differences in patients to determine who will respond to which drugs."

The full scope of personalized medicine has not yet come to fruition, but it is already influencing cancer care.

Appropriate therapeutic regimens for various cancers are being determined by molecular testing. Tumors might present as a textbook example of a certain type but with molecular techniques like florescence in situ hybridization (FISH) technology, might actually be revealed as a completely different type of lesion.

"This can especially happen with soft-tissue tumors," said Wisecarver. The ability to understand such differences is a critical skill possessed by pathologists, aiding in effective diagnosis.

Personalized medicine in a customer service culture

Patients are now more involved in their own medical choices. They are knowledgeable of many medical conditions and options for care; this change requires physicians to work more closely with patients not only as a healthcare provider, but as a partner in treatment and care.

Customer satisfaction is a common metric by which businesses measure their performance. Pathology services, which are largely unseen, do not normally make patient and client satisfaction a priority.

As personalized medicine spreads, however, pathologists play a more intricate and visible part in patient care. This new transformation requires more attention to the "business" of pathology, and leading with customer service.

Pathologists no longer solely perform tests and interpret results—they are directly involved in improving the efficiency and quality of care. Improving patient care is done largely through appropriate test utilization, and pathologists and laboratory professionals are heavily involved in the development of guidelines for both the appropriate use of laboratory tests and advanced laboratory diagnostics.

In February, my group, ASCP, the world's largest professional membership organization for pathologists and laboratory professionals, released a list of five tests that physicians and patients should question as part of the American Board of Internal Medicine's (ABIM) Choosing Wisely campaign. Our society was one of more than 50 that identified often inappropriate and potentially harmful tests that are frequently used by healthcare professionals. The goal of the campaign is to promote quality and efficiency in healthcare.

Pathology, personalized medicine, and health reform

The new era of personalized medicine can also be attributed to the changing landscape of new payment models. One of many changes to how physicians are paid, due in large part to the Patient Protection and Accountable Care Act (ACA), is value-based purchasing. The primary goal of the many reforms initiated through the ACA is a reduction in cost and an improvement in quality.

As pathologists become more involved in the development, management, and application of patient information and health records, they are well-positioned to deliver care that is personally tailored, highly effective, and cost efficient.

"Pathologists are focused on patient safety and quality," said Siegal. "[Pathologists] bring to the multidisciplinary team of physicians a unique skill set for the better and encourage more interaction between pathologist and physician."

Highlighting the value of the pathologist to patient care requires pathologists to be more visible in their hospitals, but it also requires appropriate compensation, according to Siegal.

The economics of healthcare doesn't just apply solely to the cost of care to patients. Changes to reimbursements and laboratory fee schedules are also affecting pathologists. Molecular tests can be labor-intensive and costly. Third-party payer reimbursements do not reflect the cost of performing these procedures and Medicare reimbursement rates are even lower. While pathologists are up to and able to meet the challenges presented in this new era of healthcare, it is uncertain that the United States will be able to maintain an adequate supply of experts in the field without proper compensation.

Recognition as a vital member of the healthcare team

As the field of pathology has expanded, so have the skill sets, knowledge, and value of its practitioners. The field of informatics, which is growing increasingly important as a diagnostic technique, is becoming an essential area of pathology training. This new knowledge allows pathologists to gather and interpret complex patient data using 21st century technologies. Progress in the field of molecular pathology is poised to move pathology from a referral-driven specialty to one that has direct interactions with patients. Highly specialized training in the area of molecular genetics makes pathologists invaluable as we transition to the new era of personalized medicine and care. It is important to acknowledge the benefits pathologists bring to the entire healthcare team as personalized medicine promises to transform the way healthcare is provided.

Editor's note: Founded in 1922 in Chicago, the American Society for Clinical Pathology is a medical professional society with more than 100,000 member board-certified anatomic and clinical pathologists, pathology residents and fellows, laboratory professionals, and students. ASCP provides excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals. For more information, visit www.ascp.org.

Jordan Sarver is Web Writer at the American Society for Clinical Pathology. He can be reached at Jordan.sarver@ascp.org.

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