Imagining the Future of Medicine: Sanford Imagentics
Dr. Samuel Nyatu of Sanford Aberdeen is one 170 internal medicine physicians who will be a part of the system-wide effort to integrate genomics into clinical practice.
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Even before biochemists Frederick Sanger and Walter Gilbert shared the 1980 Nobel Prize in chemistry for their separate work in DNA sequencing, medical scientists understood that the ability to create and analyze chromosomal representations would revolutionize the way medicine was practiced. After all, as the National Human Genome Research Institute states, “Virtually every human ailment, except perhaps trauma, has some basis in our genes.”
But, until the results of the Human Genome Project were released in 2003, the application of genetics in medical practice was largely limited to a set of diseases for which chromosomal abnormalities had been identified. It is only since the costly instrumentation and technical support necessary for gene sequencing has come within reach of South Dakota laboratories that genomic medicine has been poised to have a major impact on clinical practice in the region.
“I describe it as a change in mindset, a change in how you approach patients,” says Dan Blue, MD, President of Sanford Clinic in Sioux Falls. “When you have a deeper understanding of these tools and resources, you begin to see how they apply to decisions you make regarding your patients.”
Over the course of the next few months, Sanford’s 170 internal medicine physicians will begin to experience that change in mindset for themselves as they train to be a part of Sanford’s new genomic initiative, Sanford Imagenetics.
Funded by a $125 million dollar gift from philanthropist Denny Sanford, Sanford Imagenetics will allow internal medicine physicians to work hand-in-hand with clinical geneticists, genetic counselors and diagnostic clinical genetics laboratories to fully integrate high-tech genomic medicine into their clinical practice. With in-depth evaluation of family history and targeted genetic testing, Sanford says patients can expect better health outcomes and a higher overall quality of care.
“The unique thing here is that we are making it real in terms of clinical practice,” says Gene Hoyme, MD, a board-certified geneticist and president of Sanford Research. “There are some health systems that have dipped their toe in the water, in terms of pharmacogenetics, but we are truly moving this into the realm of everyday practice.”
A number of Sanford specialty providers, including physicians with Edith Sanford Breast Cancer, Sanford Children’s, Sanford Women’s and other areas, already regularly use genetic evaluation as part of their treatment planning for specific illnesses. In addition to providing high-end genetic testing for internal medicine doctors who request it, Sanford Imagenetics will imbed genetic counselors into its four largest internal medicine practices in Sioux Falls, Fargo, Bismarck, and Bemidji, Minnesota. Sanford plans to add four more clinical geneticists to its current group of five.. In some markets, physicians, counselors, geneticists, educators, researchers and lab services will be housed together.
Education of current and future providers is another major component of the initiative, as are intensified research efforts through the Sanford Clinical Molecular Genetics Laboratory. This newly-developed lab will provide single-gene sequencing, whole exome sequencing, and targeted mutation analysis in oncology and selected single gene disorders. The lab is currently seeking certification through the Clinical Laboratory Improvement Amendments program.
“Sanford Imagenetics is a major initiative because it means having the resources, the scientists, the research, the genetic counselors, the data people, the bioinformatics, etc., to make it meaningful,” says Dr. Blue. “As physicians, our role is going to be to practically apply it every day.”
Clinical Application of Genomics
Samuel Nyamu, an internal medicine physician in Aberdeen, is one of the physicians who will soon be able to take advantage of the Sanford Imagenetics initiative in the treatment of his patients. Dr. Nyamu – ‘Dr. Sammy’ to his Aberdeen patients and colleagues – says it is easy to imagine a myriad of ways in which he will be able to apply this technology in his practice.
“Almost every day I see someone who could benefit from this,” he says, referring to the program’s initial focus in pharmacogenetics. “Often, I see patients come back to my clinic because of drug side effects that could have been avoided had we had a better understanding of how they metabolize medicine. Without this genetic information, I have no idea how a given patient will metabolize medicine and I just have to give them a general dose and see how it goes.”
When physicians like Dr. Sammy identify patients for whom they believe they could use additional genetic information, such as those who need blood thinners, statins, or anti-anxiety medication, a blood sample is sent to the molecular lab in Sioux Falls. Sanford expects to begin offering the initial DNA analyses for a broad panel of pharmacogenetic screening tests this spring. Results will become part of the patient’s private electronic medical record, where they can serve as a reference for future prescribers. Internal medicine patients will also have the opportunity to undergo genetic counseling for familial disorders as well as precise genetic testing from a simple blood draw.
Educating for the Future
Sanford will provide training to its internists on the practical applications of genetics and genomics, including not only the testing itself, but also how and when to work with their genetic counselor colleagues. Sanford Imagenetics has partnered with the Sanford School of Medicine of the University of South Dakota, as well as Augustana College to develop new academic programs for the next generation of doctors, nurses and scientists in genomic medicine. A certification program and other types formalized genomic training are being considered.
“Eventually, we plan to develop a residency in genetics,” says Dr. Hoyme. “This will be a two-year training program, from prenatal genetics through adult life. Students would come right out of medical school and do a combined internal medicine/genetics residency. That is on the docket.”
“It is important that we not only expand and educate the current workforce, but that we prepare the genomic medicine workforce of the future to work at Sanford at elsewhere,” adds Dr. Blue. “We know that genomics are going to explode over the next few years and there are going to be national shortages. We are trying to proactive.”
Genomic Research Initiatives
Although it is hard to underestimate the potential value of genomic information, genomic testing is not cheap. It relies on advanced equipment and highly trained technicians and can range from $200 to several thousand dollars per test. Until the clinical benefits can be proven and documented, few payors will cover the testing. Sanford is hopeful that the data collected by Sanford Imagenetics will help change that. Until then, cash options and payment plans will be available.
“All of the things that we are suggesting need to be validated so that when they are rolled out in practice, it can be shown to be helpful to patients and insurance companies will cover them,” says Dr. Hoyme. Sanford Inagenetics will include development of a rigorous research program to define the genomic markers most successful in managing primary care for adults. “Research outcomes are written into the deliverables. We are going to be documenting and stretching and pushing the envelope.”
Genomic testing will be voluntary. Although pharmacogenetics is unlikely to raise ethical considerations, more complex questions may arise with the evaluation of disease risk. For this reason, the Sanford Imagenetics team will include a genetics bioethicist whose job it will be to help guide providers and patients through what Hoyme says can be a “quagmire” of ethical dilemmas. Genetic counselors are trained to help patients explore their thoughts and feelings surrounding genetic testing and to weigh the costs and benefits.
While the implications of genomics are far reaching for patients, Dr. Sammy says he and his internal medicine colleagues are hoping the infusion of new knowledge will also be a shot in the arm to for the specialty itself. “We, in internal medicine, are very excited because we believe that this has the potential to really re-energize our specialty,” he says. “Internal medicine can sometimes be seen as ‘boring’ in relation to other specialties, but we hope that this injection of new information and new knowledge, bringing something that has been happening behind the scenes into the forefront, will get more people interested in working in internal medicine.”
“It is a lot more than sending off a saliva or a blood sample and getting a report back,” says Dr. Blue, who says the experts of Sanford Imagenetics will serve as a resource for providers both in and outside of the Sanford system. “There is so much to be learned and explored here. The amount of information is just mind-boggling. That is why we believe it is important to be on the front edge.”