DNA-based testing is moving into a new phase. Transformational technologies are allowing complex genetic (specific gene) and genomic (large numbers of genes) tests to move from research-only labs into medical and clinical labs that perform tests for individual patients to identify genes associated with specific medical conditions. Progress in this young industry is happening fast and furious. New discoveries about the genetic basis of disease are being made every day. And even though DNA-based tests have a relatively small impact on how medicine is practiced today, each new and encouraging development is a step closer to a day when healthcare can be tailored or personalized to an individual’s genetic makeup.
This report examines the U.S. market for DNA-based test products that are commercially available today, or will be soon, to screen for disease, confirm a diagnosis in someone with disease symptoms or even determine if you carry a gene that predisposes you to disease - before it causes symptoms. Particular emphasis is given to adult genetic tests that predict risk of disease and predict the best treatment regimens for diagnosed disease.
Even as DNA-based diagnostic tests gain in popularity, matters of genetic privacy and ethics, as well as issues of reimbursement and regulation, are still being debated. The report also evaluates these potential obstacles to DNA-based tests becoming standard medical practice where they can be offered through a physician or directly to the public.