Patent-Mediated Standards in Genetic Testing

Genetic testing can be used to identify disease susceptibility, establish diagnostic status, and design therapeutic regimens in medical care. The opportunities to apply genetic knowledge to medical problems have expanded rapidly in the DNA-based era of molecular genetics. Two legal realities are also shaping the development of the genetic testing field in the U.S. First, there is no FDA premarket review of most commercially available genetic tests. Second, many DNA sequences and genetic testing methods are patented.

The intersection of these two realities explains some of the clinical dilemmas that have arisen in genetic testing.