CEO SUMMARY: Community hospitals are recognizing increased interest in personalized medicine among consumers. One expert predicts that this will create opportunities for hospital labs and pathology groups to add value by offering subspecialty expertise in molecular diagnostics, genetic testing, and “companion informatics.” At the University of Louisville School of Medicine, the Department of Pathology and Laboratory Medicine is actively supporting education in these emerging new subspecialties.
IT IS MUCH EASIER TO PREDICT how the future of laboratory medicine will unfold than it is to establish pathology training programs specifically designed to prepare young pathologists and clinical laboratory scientists for a practice of medicine that does not yet fully exist.
Take the concept of “companion informatics,” for example. Not only does Roland Valdes, Jr., Ph.D., predict that this rapidly-developing field will be essential to the accurate clinical use of companion diagnostics by physicians, but he and his colleagues are developing a focused training program to prepare young pathologists to be experts in this exciting new field of laboratory medicine.
Valdes is Professor of Pathology and Laboratory Medicine and Biochemistry and Molecular Biology at the University of Louisville School of Medicine. He is convinced that personalized medicine is about to create powerful new opportunities for hospital laboratories and hospital-based pathology groups.
“Of course, the easy prediction is that acceptance of personalized medicine will require hospital laboratories to add that expertise to their menu of testing services,” noted Valdes. “However, what pathologists often overlook is that patients—the ultimate consumers—will be playing a greater role in selecting their hospital provider. They are going to prefer using a hospital that has a laboratory capable of performing complex molecular and genetic tests, or at least have ready access to them.
Evolution of Lab Medicine
“What is more difficult to predict is how personalized medicine and genetic testing will transform the practice of laboratory medicine as we know it today,” continued Valdes. “In my view, pathologists who have the skills to support this transformation will have the greatest opportunity to add value and be paid appropriately for this value.”
To be specific, Valdes believes that a major change in lab test referral patterns is about to occur. “Today, most community hospitals send out their molecular assays and genetic tests to reference laboratories,” he observed. “However, lab administrators and pathologists in these community hospitals are realizing that there is value in being a local provider of personalized medicine and the lab testing associated with it.
“There is no doubt that pathologists can grow their business by advertising the benefits of personalized medicine to consumers,” he said. “By doing so, hospitals and health systems can increase their census by attracting new patients.
“Today, this is generally seen only in some of the larger institutions, such as the Mayo Clinic and those hospitals affiliated with Vanderbilt University, among others,” commented Valdes. “But we already see more hospitals recognizing this growth opportunity in personalized medicine. It is why a growing number of hospitals are starting to hire pathologists and laboratory scientists who are certified in the fields of molecular diagnostics and genetic testing, for example.”
This is where Valdes says the field of “companion informatics” is poised to provide great opportunity for pathologists and laboratory scientists. In fact, his pathology department was so committed to this belief that, eight years ago, it established one of the nation’s first training programs in pharmacogenetics and diagnostic informatics.
“The term ‘companion diagnostics’ has been around a long time,” noted Valdes. “These are assays intended to assist physicians in making treatment decisions for their patients. Their particular function is to assess the efficacy and/or safety of a specific drug for the patient.
“We recently introduced the term ‘companion informatics’ to describe the coupling of molecular diagnostic information with informatics in order to provide actionable information to physicians about which medications to use and what size dose would be appropriate,” he explained.
“Informatics, meaning both diagnostic informatics and companion informatics, are literally transforming the discipline of laboratory medicine,” emphasized Valdes. “We coined this term in response to what we are observing to be the needs of our hospital clients.
“These hospitals tell us they need help in the areas of molecular and genetic testing,” he added. “Particular needs are in pharmacogenetics, diagnostic proteomics, and diagnostic informatics.
“It is not likely that hospital laboratories will require subspecialists in each of these three fields,” commented Valdes. “Technology will see to that. Ongoing developments in diagnostic informatics and companion informatics will help achieve standardized interpretations.
“With standardized interpretations, pathologists or lab scientists with two different kinds of specialties could handle most of these calls,” he explained. “Keep in mind that, today, most of this work is done in large reference labs, such as ARUP Laboratories and Mayo Medical Laboratories. But eventually smaller hospital labs will do this work routinely because the equipment to perform this testing is becoming cheaper, less complex to operate, and more accurate.”
In his experience dealing with community hospitals, Valdes believes that personalized medicine will not only be used by hospitals to attract patients, but personalized medicine also has the potential to remake lab medicine into one of the most important specialty practices within the hospital.
“Today pharmaceutical therapies are critically important,” he noted. “But there are signs that diagnostics could eventually trump pharmaceutical therapeutics, primarily because test results will determine the most efficient treatment course and efficiency of any drug before therapy is applied.
Guidance by Pathologists
“Under this new paradigm, guidance by pathologists and laboratory scientists is critical for efficacy and improved patient outcomes, not to mention reducing the overall cost of the healthcare encounter,” observed Valdes. “In my view, the future of laboratory medicine lies in progressive interpretation of novel testing modalities.
“This will be most obvious in the use of molecular diagnostics as a companion diagnostic test,” said Valdes. “As this occurs, the subspecialty field of companion informatics will be one way that hospital labs can deliver more value to physicians and patients.”
The experience of the laboratory at the ULSM provides an interesting window into the awareness of community hospitals that their respective laboratories should be acquiring this subspecialty expertise in molecular diagnostics.
Responding to Evolution in Lab Medicine, Subspecialty Post-Doctoral Programs Added
REACHING BACK AS FAR AS THE LATE 1980s, the Department of Pathology and Laboratory Medicine at the University of Louisville School of Medicine (ULSM) has instituted new training programs in response to changes unfolding in the field of laboratory medicine.
“Following that post-doc program in clinical chemistry, we added a subspecialty in clinical pharmacogenetics,” recalled Roland Valdes, Jr., Ph.D. Professor of Pathology and Laboratory Medicine and of Biochemistry and Molecular Biology at the ULSM. “Next came a subspecialty in diagnostics proteomics.
“The unique challenge of molecular diagnostics—and pharmacogenetics in particular—is to find a clear, actionable clinical pathway for the application of lab results,” he continued. “That is why, about five years ago, we added diagnostic informatics as a third subspecialty.”
Along with training pathologists and other lab scientists in these subspecialties, the Department of Pathology is involved in collaborations to apply diagnostic informatics and companion informatics to practical solutions that deliver clinical value. “PGXL Laboratories, located here in Louisville, is affiliated with the University of Louisville,” said Valdes.
“Earlier this year, we developed our first product from this work at PGXL Laboratory,” he noted. “It is the PerMIT (personalized medicine interface tool).
“Its use can be illustrated by applications in warfarin therapy,” explained Valdes. “The PerMIT tool pulls together the molecular diagnostic information, the pharmcogenetic information, and the patient data on drug response. With this information, our pathologists and lab- oratory scientists can give physicians timely and accurate guidance on how to dose for warfarin, which is a difficult drug to use.
“This companion informatics product is moving into broader clinic use,” he continued. “It was in March when ARUP Laboratories, located in Salt Lake City, became the first lab to use the PerMIT software to estimate warfarin dosing to stabilize a patient.
“PGXL Laboratories is seeking to develop similar diagnostic informatics tools for use with different drugs and in the treatment of different medical syndromes,” Valdes said. “Cardiovascular medicine is an area of interest, as are oncology and psychiatry.
“There is potential to use companion informatics in identifying treatment for KRAS and other mutations,” concluded Valdes. “There are opportunities in psychiatry to help predict drug response based on a patient’s metabolism, and in pain management to help predict the activation and elimination of pain medications.”