Precision Medicine and the Lab

Will facilities harvest anticipated benefits from new technologies in precision medicine?

The “in” designation for targeted quality healthcare seems as changeable as hemlines. But whether it’s termed Individualized care, personalized healthcare or precision medicine, the threads that hold it together are better outcomes — for both patients and facilities.

Karen Kaul, MD, PhD, chair of the department of pathology and laboratory medicine at NorthShore University HealthSystem (NorthShore), formerly led their molecular diagnostics laboratory, which provides much of the DNA-based testing to the health system’s newly opened Center for Personalized Medicine. She is not shy about suggesting that labs are taking the lead in the personalized medicine arena. “Labs already have been doing ‘personalized medicine’ for a long time,” reminded Kaul, who’s been active in MDx since 1987, which she calls “the dark ages in terms of our ability to analyze DNA. But the recent explosion in our knowledge and our capacity to analyze DNA has really shot us into the limelight.”

Indeed, Kaul connects the very definition of precision medicine to diagnostics. “To me, personalized medicine is defined as genome-informed clinical management of patients. Without DNA-based testing, there could be no personalized medicine.” And as testing explores a multiplicity of genes and mutations associated with various disease states, therapies are becoming more targeted and more likely to succeed, she added.

She gets no argument from Douglas Silverstein, president, Evanston Hospital NorthShore University HealthSystem, who regards the health system’s foray into molecular diagnostics as a primary signaling pathway to the creation of their Center for Personalized Medicine.

“We’ve had components for the center in place for a long time,” he explained. “Many of our researchers have been interested in genetics, many in the area of oncology. It became apparent to us that we had all of the resources, in terms of clinical and research expertise, to be preeminent in an area that is probably going to impact every clinical area involved in medicine. It made sense to pull our pieces together into a formalized center so that we all were acting as cohesive collaborators as opposed to individual silos.”

NorthShore has also taken the step to hire a pharmacogenomics expert, and vigorously build a Genomic Health Initiative research study involving the collection of over 100,000 patient samples and 13 years of electronic health record information. Taking advantage of such existing capabilities has not only been productive in pushing personalized medicine forward, but in attracting research and clinical talent to NorthShore as well, said Silverstein.

“As we see the financial side of healthcare changing and moving to an at-risk financial or value-based relationship for patient care, we need to make sure that the patient care processes are as efficient as possible. So the more information you have on your patient, the better interventions you can provide,” said Silverstein. “If that information contains genomic details, we are likely to provide better quality and more cost-effective care.”

Beyond Genetics

While genetics may be the kingpin of personalized medicine, it’s not all about genetics. “For CEOs of health systems, personalized medicine must take on two complementary definitions,” suggested Sachin Jain, MD, chief medical officer of CareMore Health Plan, lecturer in Health Care Policy at Harvard Medical School and an attending hospitalist physician at the Boston VA-Boston Medical Center.

“The first definition is clinical and scientific and relates to making sure patients receive medicines and other therapies that are appropriately tailored to their genetic profiles,” said Jain of the accepted notion of the importance of DNA test-driven precision healthcare. “The second definition relates to the emerging realization of the importance of patient experience, and the efforts to make sure that clinical care delivery is both what the patient needs and wants. This imperative is about carefully assessing a patient’s care delivery preferences and making sure that they receive care in line with those preferences,” said Jain.

Both definitions are important — and both will lead to important changes in how healthcare organizations operate, Jain told Executive Insight. “Both clinical care and clinical service delivery have historically centered on a view of the ‘median patient,’” he said. “Healthcare is finally waking up to the reality that there is no such thing. Patients are different — and will often have different preferences and needs around which we should tailor the clinical experience.”

This directive calls for a great degree of flexibility, and a variety of healthcare approaches by an agile health system. At CareMore, Jain said a significant amount of time — about 90 minutes — is spent early in the patient’s care journey to assess needs and preferences. “We ask detailed questions about health status, social supports and psychological health. We use this appointment to direct patient enrollment into a variety of targeted programs that get right at the patient’s needs. This upfront assessment enables us to personalize a patient’s therapy,” he offered. “It’s a critical step for moving forward as a top health system.”

Jain advised other organizations to find similar strategies that set them apart from the healthcare herd. “Healthcare organizations that truly work to understand patients will ‘win.’ They will differentiate themselves from the majority of organizations that do not recognize the heterogeneity of patients,” said the former advisor who helped to launch the Center for Medicare and Medicaid Innovation. “Further, the best systems will develop detailed ‘memories’ about patients. They won’t force them to fill out the same forms over and over again, or answer the same questions repeatedly. They will customize patient experience based on an accumulated knowledge of the patient that builds on itself. In the most critical moments of their lives, patients want to believe they are known and visible to the people to whom they entrust their lives.” Short of that, said Jain, patients will simply walk away.