Barriers to the Introduction of New Medical Diagnostic Tests

Driven by rapid developments in sequencing technologies, proteomics and other progresses in biological sciences, new diagnostic tests are expected to play a growing role in medicine as well as in tailoring medical treatments to specific patients. The road of a test from bench top to patient is a difficult and incremental process. This report examines the barriers that exist to the introduction of new diagnostic investigations into routine medical practice. These barriers are manifold and include the burden of proof in establishing the scientific validity and clinical usefulness of a new test; regulatory hurdles; issues surrounding costs, coverage, and ensuring appropriate compensation for the work that goes into the development and delivery of a new test; a preference amongst physicians for traditional diagnostic methods that are often less formal and require a higher degree of expert analysis and interpretation; and resistance to more broad-based genetic testing by the general public, including ethical concerns about the possibility of genetics-based discrimination.