CEO SUMMARY: As genomic medicine advances, researchers into various diseases quickly recognize the need to incorporate molecular pathologists onto their teams. In Grand Rapids, Michigan, a large integrated health system and a private research institute have come together to jointly fund a state-of-the-art molecular pathology laboratory. The twin goals are to advance research and create new assays to offer to clinicians.
ONE OF LABORATORY MEDICINE’S EARLY PIONEERS in molecular pathology and diagnostics has taken a leadership role in a unique new organization. Recently, Daniel H. Farkas, Ph.D., was selected to be Executive Director of the Center for Molecular Medicine (CMM) in Grand Rapids, Michigan.
For the laboratory medicine profession, there are several noteworthy aspects about the creation and goals of the Center for Molecular Medicine. Its creation demonstrates the important role molecular pathology plays in genomic medicine.
Joint Venture Laboratory
First, CMM is a joint venture between two organizations based in Grand Rapids. The partners are Spectrum Health (a seven-hospital health system) and the Van Andel Institute (a biomedical research laboratory and facility). CMM has $6 million in funding, each party contributing $3 million of that total.
Second, CMM has ambitious goals. Its partners say that the mission “is to offer 21st century molecular technologies for investigation of such complex diseases as cancer, heart disease, mental illness, and other conditions at the DNA, RNA, and protein levels.” Expertise in molecular pathology, both in research and in clinical settings, is required. That is why Farkas, who established molecular diagnostics programs at three hospitals over the course of his 20-year career, is heading up CMM.
Third, partnership between Spectrum Health and the Van Andel Institute is another example of a developing trend. The Van Andel Institute is funding primary research, but needs access to a patient population to apply new knowledge in clinical settings. For its part, Spectrum Health provides access to patients. At the same time, it participates in developing cutting-edge medical services that it can offer in its community.
The approach of partnering a research institute with a health system that provides access to large patient populations is gaining favor. Kaiser Permanente is one example. Another is Geisinger Health System, which founded the Center for Health Research and Rural Advocacy to conduct research and create a gene biobank.
Fourth, the Van Andel Institute’s decision to invest in a molecular pathology laboratory is a sentinel event for the pathology profession. It is an early example of a family-funded foundation devoting considerable resources in laboratory medicine to advance healthcare knowledge.
Alert readers may recognize the Van Andel name. Jay Van Andel was one of the two founders of Amway Corporation, a private company with sales of $6.3 billion last year. Van Andel and his wife, Betty, through their foundation, created the Van Andel Institute in 1996.
Its primary goal is to advance research into cancer and Parkinson’s disease and translate scientific research results into clinical applications. As genetic knowledge has advanced during the past decade, it is no surprise that the Van Andel Institute recognized the need to establish a molecular pathology laboratory to support this ongoing research.
To Benefit Clinical Services
“To fulfill the mission of the Van Andel Institute, we must move our findings from the research laboratory to the clinical laboratory,” said David Van Andel, Chairman and CEO of the Van Andel Institute. “The Center for Molecular Medicine will allow us to do this in an accelerated fashion and positively impact human health. We have the research expertise and Spectrum Health has a large patient population which allows us to apply what we’re learning directly into the clinical setting.”
Farkas agreed, saying, “In molecular diagnostics, over the last 20 years or so, we have perfected new gold standards for infectious disease diagnostics, brought many new tests for disease-causing mutations on-line and made great strides in diagnostics and prognostics for cancer, including leukemia, lymphoma, breast cancer, and more. All of these developments and the creation of new technologies have contributed mightily to the incredible growth of molecular diagnostics—to the point where it represents today perhaps 10% of the total in vitro diagnostics (IVD) market. That’s about $3 billion, where 20 years ago that number was zero.”
“CMM accelerates the drive toward personalized medicine—the tailoring of treatment based on molecular make-up,” stated Richard C. Breon, President and CEO of Spectrum Health. “We plan to offer physicians and their patients the most advanced diagnostic treatment options available, options typically offered only at the nation’s largest academic medical research centers.”
CMM is embarking on the next generation of molecular diagnostics tests for diseases with multigenic etiologies, Farkas said. “Science completed sequencing of the human genome in 2003, which marked the beginning of the era of genomic medicine,” he noted. “Single gene tests dominated the 1980s, 1990s, and the early part of this decade.
“For researchers, the next challenge is to learn the multigenic causes of complex diseases so that we will be able to diagnose and manage conditions such as solid tumors, diabetes, and neuromuscular diseases more effectively,” Farkas continued. “CMM is organized specifically to implement, at the clinical diagnostics level, the fruits of this sort of multigenic research.
New Molecular Tools
“In many ways, developing 21st century molecular diagnostics is visionary,” Farkas explained. “The work in this field requires a substantial financial investment. Test volumes for these sorts of tests today are low and may not be sufficient to financially sustain the laboratory immediately. That is because the tests need to establish their worth before clinicians will start ordering them in large numbers.
“Further, reimbursement by insurers at this early stage is sometimes problematic as they gain comfort with the medical necessity of these tests’ value,” Farkas added. “Nevertheless, the vision of CMM is to offer these assays in a clinical laboratory environment; if we’re ahead of our time, we won’t be for very long.
“In my work at the William Beaumont Hospital, in Royal Oak, Michigan, in the mid-1990s and at The Methodist Hospital in Houston, we realized the molecular tools we used in our work would advance remarkably in lock step with new technology,” Farkas explained. “We were confident that sequencing of the human genome would open up new areas for diagnostic molecular pathology.
“CMM will make these new tests available to any physician who wishes to use them to manage his or her patients,” he said. “Also, as we develop clinically useful diagnostic tests, we will accept specimens from physicians and labs around the country. At the same time, we don’t necessarily plan to turn CMM into a full blown or even miniature IVD company. If we develop tests that are not esoteric, and that have significant markets, our inclination is to partner with established IVD companies and provide licenses.
“CMM also wants to offer useful technology to the entire country as opposed to just being a central reference laboratory,” Farkas continued. “In that sense, our business plan is more ecumenical than the business plan of a centralized reference lab.
“Clearly, the entire lab industry is moving toward genomics, and so the creation of CMM by the Van Andel Institute and Spectrum Health makes the timing right for this venture,” Farkas explained. “Our laboratory is a compelling venue for companies in genomics, pharmaceuticals, and diagnostics to use as a location for clinical trials. We have four critical elements that we can exploit: translational research, hospital resources, biotechnology, and bioinformatics.
Working With Payers
“In addition, we plan to demonstrate to third party payers that the tests we will develop should be reimbursed,” he said. “We know what we have to do to demonstrate the clinical relevance of these tests, and we are eager to work with third party payers in Michigan, such as Blue Cross Blue Shield and Priority Health, and elsewhere in the country. Additionally, clinical testing and clinical trials are revenue opportunities for us.”
THE DARK REPORT observes it is particularly noteworthy that a family foundation is funding a laboratory organized around molecular pathology. It demonstrates how the pathology profession is poised to be an essential resource in developing personalized medicine and improving patient outcomes.
Farkas Earns Award In Molecular Pathology
ON APRIL 3, the Association for Molecular Pathology (AMP) revealed that the 2007 winner of its Leadership Award was CMM’s Executive Director and AMP’s past President, Daniel H. Farkas, Ph.D.
With this recognition, Farkas joins earlier recipients of the Leadership Award. In 2005 the winner was Jeffrey A. Kant, M.D., Ph.D. and in 2006 it was Mark E. Sobel, M.D., Ph.D. Daniel H. Farkas, Ph.D., HCLD, CLSMB, has established three hospital-based molecular diagnostics laboratories in 20 years in the field. He has headed up molecular diagnostics labs at Saint Barnabas Medical Center in Livingston, New Jersey; at William Beaumont Hospital, in Royal Oak, Michigan; and at The Methodist Hospital, in Houston, Texas.
In his career, Farkas has held faculty positions at Weill Medical College of Cornell University, Baylor College of Medicine, and at William Beaumont Hospital. He is currently an adjunct associate professor at Michigan State University.