The deadline is up today for 13 personal-genomics companies that were sent cease-and-desist letters last week by the state of California. The companies, which offer genetic-testing services directly to consumers via the internet, will need to show that they are complying with state law. Most notably, they will need to prove that physicians order the tests.

These actions are likely just a hint of the regulatory battles to come. The direct-to-consumer testing market has boomed in the past year, thanks to a flood of studies linking specific genetic variations to disease, and also thanks to cheaper technologies to detect those variants. Along with that growth has come increasing scrutiny over how the medical information inherent in an individual's genetic information should be used and regulated. As the debate unfolds, scientists, regulators, and entrepreneurs will need to grapple with the central question of how to define this new breed of medical information, which falls short of being a diagnostic tool and, unlike risk factors such as cholesterol levels and blood pressure, is deeply personal and ultimately immutable.

"The current situation is reminiscent of Napster," says Steven Murphy, a physician and founder of Helix Health, a personalized-medicine practice in New York. "[That company] created a disruptive technology to share music, and the government wasn't prepared to deal with it. But just like with Napster, there's a fight coming, and [the personal-genomics companies] are going to lose."    Read More...