It may be that the hospital industry’s first implementation of genetic testing will be to support improved use of the prescription drug warfarin in anti-clotting therapy. Healthcare companies and hospitals are banking on the fact that genetics can answer questions about which drugs are safe for individuals to use. Medco Health Solutions and the Mayo Clinic are currently collaborating on a study on personalized medicine to confirm whether genetic testing can help eliminate the life-threatening and costly complications that many patients develop after starting a prescription of the anti-clotting drug warfarin.
This is the latest study in the realm of “personalized medicine,” in which physicians use genetic or other molecular tests to tailor a patient’s treatment. Promoters of personalized medicine say the science boils down to delivering the right treatment at the right dose to the right patient at the right time. Doctors use genetic testing to customize the dosage of a drug, determine which treatment will work and which may pose safety problems, and determine a patient’s susceptibility to disease. These customized therapies have already been put to some clinical use and drug makers, biotech companies, medical institutions, testing laboratories, and government agencies such as the Food and Drug Administration and National Institutes of Health all appear eager to advance the practice.
Each of the types of companies listed above have a different incentive to support personalized medicine. Drug makers and biotech companies can increase their profit by developing drugs tailored to people with specific genetic make-ups. Medical institutions can provide better and safer care to their patients. Government agencies can look forward to a reduction in side effects and health-care spending to treat those side effects (A study by the American Enterprise Institute and the Brookings Institute estimates that the use of genetic testing to personalize dosages of warfarin alone could reduce health care spending by $1.1 billion a year).
For clinical laboratories, the widespread use of genetic testing to tailor drugs and drug dosages has long been expected to increase utilization of genetic assays. Should health insurers discover that the inclusion of these tests in treatment protocols can save billions of dollars now spent in treating life-threatening side effects, then it is likely that payers will offer adequate reimbursement for genetic testing that contribute to a reduction in negative side affects. The FDA has already approved personalized medicine drugs from Genentech, Novartis, and Roche Holding.
Ongoing advances in the knowledge of how genetics can affect specific diseases are being combined with new technologies in molecular diagnostics to create assays which have improved levels of sensitivity and specificity. Should healthcare leaders like the Mayo Clinic introduce clinical protocols such as genetic testing linked to warfarin prescriptions, then the day is not far off when most of the nation’s community hospitals will similarly embrace this type of genetic testing for their patient population. Progressive pathologists and laboratory directors should be developing strategies that prepare their laboratories to support this next generation of molecular diagnostics.