Considering the potential harm of exhaust fumes, it seems ironic that the heart of the automotive industry should be setting its sights on a future in the biomedical sciences. But that is exactly what Grand Rapids has decided for the course of Michigan’s future. Investing a total of $6 million of private funds — half each from Spectrum Health and the Van Andel Institute — into the newly minted Center for Molecular Medicine, the community hopes to not only embrace biomedical research, but also establish itself as a center for biomarker discovery under the larger umbrella of molecular diagnostics.
Based in Grand Rapids, Mich., the Center for Molecular Medicine is a joint venture between the Van Andel Institute, a leading independent biomedical research organization, and Spectrum Health, a healthcare system based in western Michigan that serves more than 650,000 patients every year. Known for its translational expertise, Van Andel hopes to leverage the CMM’s CLIA-certified and CAP-accredited laboratory to run tests that it couldn’t otherwise run in its own labs. Meanwhile, Spectrum Health is looking to perform clinical trials and other molecular diagnostic procedures that it wouldn’t be able to do in a non-CLIA environment.
According to Daniel Farkas, executive director of the CMM, the lab will offer both cutting-edge, FDA-approved molecular diagnostic tests for the surrounding clinical community as well as the opportunity to partner with biotech and pharmaceutical companies who will use the CMM’s genomic and proteomic technologies to run clinical trials or build out and commercialize their own tests in a CLIA/CAP environment.
“Spectrum and Van Andel are obviously large players in this and they perceive the Center for Molecular Medicine as an outlet for the translational research that’s being done at Van Andel, for new testing that can help Spectrum’s ... patients,” Farkas says. As part of Grand Rapids’ desire to move toward being a leader in molecular and personalized medicine, it created the CMM, which is actually housed in the Grand Valley State University’s Cook-DeVos Health Sciences Center.
“More concretely, what [Spectrum] brings to the table are the access to patient specimens, a wonderful electronic medical record, a very well seasoned clinical trials coordination department,” Farkas says. “Van Andel brings … biobanks, its translational research … and lastly its bioinformatics.”
Ahead of the curve
At the moment, the CMM has a staff of four, and offers three FDA-approved tests for area clinicians: Roche’s Cytochrome P450 genotyping test and Veridex’s CellSearch-breast and CellSearch-colon tests for circulating metastatic tumor cells. Farkas initially chose the CellSearch assays because he didn’t want to pigeonhole the CMM as a molecular diagnostics lab that would only perform nucleic acid-based tests. Plus, he says, the tests he chose are non-routine and cutting-edge.
“The overarching theme is that the Grand Rapids community is extremely entrepreneurial, is extremely philanthropic, and is extremely forward looking,” Farkas says of his decision to help start the CMM. “We’re not thought of as a hotbed of biotech or molecular diagnostics, so I have to go out on a limb a little bit. And that’s why I’m not bringing on routine tests, but only ahead-of-the-curve tests.”
On a secondary level, the CMM will also make itself available for partnerships with biotech and pharmaceutical companies to develop assays, run trials, or further validate and commercialize existing or fledgling technologies. The center will charge a fee for service, and Farkas hopes this will become the institute’s actual bread and butter. So far, they’ve inked one high-profile deal with Xceed Molecular, formerly known as MetriGenix. Xceed is using CMM’s lab equipment and space to run quality control data on its RNA-based gene expression chip, and plans to use CMM’s expertise to develop an oncology chip as well.
Though the lab runs just three assays at the moment, Farkas is thinking about bringing a few more onboard in 2008. “I intentionally want to keep the clinical laboratory test menu fairly light because patients always come first,” he says, “even if that means that I have to put behind them the work of a multimillion dollar project that we’ve brought in from company X, Y, or Z.”
Working with patients
At the heart of the CMM is the translational research that precedes the actual assays that the center runs. Craig Webb runs a lab that studies tumor metastasis and angiogenesis. In addition to running gene expression analyses on tumor cells, the lab is very much a part of the initiative to make biomarker-driven clinical trials and personalized medicine a reality. Working with Spectrum Health as a source of patients, and the CMM as the CLIA-certified lab to run assays, Webb’s lab at Van Andel spends the majority of its time using computational analysis to predict how tumors will respond to different drugs.
One example of the work at Webb’s lab is what he calls the “predictive therapeutics protocol.” Using gene expression profiles of late-stage cancer patients, Webb deploys bioinformatics software tools to statistically predict which drugs are most likely to interact positively within a patient’s system, and therefore be potential therapeutics. “It’s not a validated test; it’s exploratory,” Webb says. “But we are moving it to a 200-patient trial to see the merit of using gene expression data to actually predict novel, personalized combinations of drugs.”
In addition to making predictive, accurate, and testable models of drug response and interactions, Webb’s team is developing early content signatures for “mesothelioma prognosis/outcome, as well as colorectal cancer metastatic potential.”
A final, and probably larger, goal of Van Andel and the CMM is to make the best use of existing drugs through modeling reactions, and then to profile patients before time, money, and health are spent on wrong prescriptions. Webb feels that that’s the best way to actually implement this idea of personalized medicine. “My concern for the field of biomarkers and personalized medicine is the delayed development time that’s required for each test, for each specific disease, for each drug,” he says. He hopes that his lab’s work will eventually eliminate the need for some of these tests and change the standards of diagnosis and care.
“If you think of it at the bench level, it’s just molecular biology,” Farkas says. “I don’t mean to trivialize it, but every aspect of any molecular pathology test involves DNA extraction, DNA amplification, and DNA hybridization. There are variations on that theme ... but if you know how to do those things, then you can dedicate your resources to it, then you can satisfy a whole bunch of projects.”
Center for Molecular Medicine
Grand Rapids, Mich.
Host: Partnership between Spectrum Health and the Van Andel Institute, Grand Rapids, Mich. Housed at Grand Valley State University’s Cook-DeVos Health Sciences Center.
Executive Director: Daniel Farkas
Established: March 2007
Staff: Four, plus administration
Funding: $6 million initial funding ($3 million each from Spectrum Health and Van Andel)
Molecular diagnostics focus: With its CLIA-certified, CAP-accredited lab, the institute runs a number of tests for researchers — including Affymetrix microarray chips — as well as tests for clinicians, such as Roche’s Cytochrome P450 genotyping test and the CellSearch breast and colon tests from Veridex.
’Omics tools: The institute also offers a variety of genomic, proteomic, and bioinformatic capabilities, such as PCR and array analysis. It also gives researchers access to Xenobase, a computational clinical management database.