Effects on Tests

Various health regulators and government bodies are reviewing gene patents, and Bloomberg says "the changing landscape" may affect companies like Quest Diagnostics, Roche, and Pfzer, as well as how personalized medicine may be implemented. In addition, the US Food and Drug Administration is considering new oversight of lab-developed tests, including genetic tests. David Mongillo, who was formerly with the American Clinical Laboratory Association, tells Bloomberg that FDA regulations would slow the field down, and hurt patients. FDA's Jeffrey Shuren disagrees, saying that bad lab tests are what hurt patients.