Jon R. Cohen, MD

Jon R. Cohen, MD, senior VP and chief medical officer, Quest Diagnostics, Madison, NJ, who also oversees the company’s hospital services business, felt a calling early in his career to improve the delivery of health care and the progress toward widespread adoption of personalized medicine. CLP recently spoke with Cohen regarding trends in the health care industry, personalized medicine, and what Quest Diagnostics is doing to move the industry forward.

CLP: Tell us about your academic, professional, and political background, and what drew you to Quest Diagnostics.

Cohen: Most of my professional career has been in academic medicine. I trained in surgery at the New York Hospital-Cornell Medical Center and did my vascular surgery fellowship at the Brigham and Womens’ Hospital. As chairman of surgery of a large academic medical center, I first learned about hospital operations. Then, as chief medical officer for the North Shore–Long Island Jewish Health System, I learned a great deal about health policy, medical finances, and health system operations. There are so many things wrong with the delivery system that instead of complaining about it, I decided that to make substantial change, I should run for public office. In 2005 and 2006 I ran for lieutenant governor of New York on a platform of health care reform. Subsequently, I was appointed as senior advisor to New York’s Governor David Paterson, where I was responsible for all strategy and policy. All along it was evident to me that one of the greatest needs in medicine was earlier diagnosis and prevention. We need to move the health care system away from a “sick care system” where we mostly take care of people when they are ill. Early diagnosis coupled with pre-emptive medicine is the real way to have a sustainable impact on peoples’ lives. Early diagnosis, when most people have no symptoms, is mostly dependent on advanced molecular and genetic diagnostics. I felt that if I were to help make a bigger impact on the delivery system, Quest Diagnostics would be a great place to realize that goal.

CLP: How are clinical labs spearheading discoveries in personalized and preventative medicine?

Cohen: Clinical labs are the intersection where science, technology, and clinical practice come together. At our company we have 100 full-time experts investigating and developing new diagnostic tools every day. Our recent acquisition of Celera deepens this capability to a significant degree. We routinely collaborate with academia, government, biotech companies, and technology manufacturers to develop new tests for FDA submission, and we strive to develop testing services no other company can offer.

CLP: How does personalized medicine, backed by lab testing, help improve patient outcomes, and are logistics of lab diagnostics changing drastically as a result?

Cohen: Personalized medicine based on diagnostic testing has the potential to radically improve patient outcomes. Look at the case of warfarin. This pharmaceutical therapy is one of the most widely used blood thinners in the world—and potentially dangerous, causing bleeding in patients with certain genetic variants. A study from June 2010 in the Journal of the American College of Cardiology reported that use of a genetic test to identify these variants and hence prevent warfarin administration could reduce hospitalizations overall by 31%.

CLP: Does personalized medicine hold greater promise for treating particular diseases/conditions?

Cohen: Much of the progress to date has been in cancer. Major pharmaceutical advances for treating breast cancer (HER2/neu testing), metastatic colorectal cancer (EGFR/KRAS mutation analysis), melanoma (BRAF mutation analysis) and, more recently, lung cancer (ALK gene status), have only been possible because of companion tests offered by Quest Diagnostics and other labs. Looking ahead, I expect the pace of innovation will pick up for other diseases as more is learned about their molecular basis. Genetic tests for predicting warfarin and Plavix response are major achievements, but they only scratch the surface of the potential of personalized medicine to improve outcomes for patients with cardiovascular disease. One of the most promising areas is in cholesterol testing. A growing body of literature shows that standard lipid testing can miss some high-risk patients. Genetic testing that helps to identify patients whose lipid profiles look normal but who are still at risk—and also helps to identify the therapy to reduce that risk—will be a true medical breakthrough.

CLP: What are the short- and long-term economic benefits of wide adoption of personalized medicine?

Cohen: Enormous. Each year, the US spends about $300 billion on pharmaceuticals. But some studies suggest that anywhere from 20% to 75% of that does not improve patient health, and may well harm it. The rate of efficacy for standard drug treatment in cancer is in the range of 25%. Imagine the costs that could be saved if diagnostics helped to get the response rate up to 50% or 80%?

CLP: What are some of the challenges hindering the adoption of personalized medicine?

Cohen: There are several challenges. They range from the difficulty of implementing large-scale randomized trials to validate a therapy or diagnostic, to helping payors understand the value of cutting-edge molecular tests, to improving outcomes and reducing costs. In addition, educating physicians and patients in the advantages and limitations of lab tests to personalizing therapy is a persistent hurdle. Another impediment is that the health care industry tends to work in silos, which hinders innovation. Labs need to foster collaboration with academia, health plans, pharma, and other partners to promote innovation. In the case of Quest Diagnostics, about 100 of the 900 MDs and PhDs who comprise our scientific team are advisors from academia. They work closely with our internal medical experts to develop diagnostics that serve a large, unmet clinical need.

CLP: As a health care policy expert, how have recent health care reforms, and how will future, expected reforms, affect discoveries and further adoption of personalized medicine?

Cohen: Current estimates are that 15 to 20 million more people will have access to health insurance under the new reform act. Any time more people get insured, it means more people will get the care they need and deserve. Most of these newly insured are younger and healthier. They are more knowledgeable and will demand the cutting-edge therapies that are evolving. The move toward wellness will help drive innovation and discovery to make these people healthier. Business and government also need to collaborate to ensure regulatory systems promote safety without sacrificing innovations that could unleash the full potential of personalized medicine.

CLP: In mid-May, Quest finalized its acquisition of Celera, which specializes in developing and manufacturing molecular diagnostic products and runs a CLIA-certified lab that performs genetic testing. What is on the horizon for Quest in terms of personalized medicine approaches?

Cohen: In recent years, Quest Diagnostics has focused on delivering testing innovations serving large unmet clinical needs for cancer, cardiovascular disease, and infectious disease. In 2010, about 36% of our revenues derived from gene-based and other esoteric tests and anatomic pathology, compared to 19% in 2000. Going forward, we expect to continue to focus on these diseases with an emphasis on high-end gene-based testing, including for aiding personalized medicine. The acquisition of Athena added an important fourth plank—neurology—to our business, while the acquisition of Celera and its Berkeley Heart Labs deepened our gene testing expertise, particularly in cardiovascular disease. Over time, these two companies will enable us to offer our hospital and physician clients greater access, convenience, and breadth of diagnostic services.

Chris Gaerig is associate editor of CLP.