

A couple of weeks ago, the state of California sent cease-and-desist letters to 13 genetic-testing companies asking them to stop directly marketing their tests to consumers.

Since then, debate has raged in the blogosphere about whether the health department should have engaged in such regulatory action. But what if health department officials don't see their action as a choice, but rather as dictated by the current (correct or incorrect) state law?

A look at the clinical laboratory regulations in California law does seem to support the idea that the health department has a case that its actions were required by law. And given that the agency's clinical laboratory oversight is currently in the midst of a statutory state audit, it might not be in a position to play softball with a widely publicized industry that's in a murky legal place.

The department is claiming jurisdiction over genetic tests because they say they constitute a "clinical laboratory test." The state's Business and Profession Code provides this long and hairy definition for such a test (1206.A.4):

"Clinical laboratory test or examination" means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.

Simplifying, one can say that a regulated lab test is composed of four parts: 1) a biological specimen from a human 2) containing some substance (say, DNA

or white blood cells) that 3) is measured 4) to give information about a human's disease-state or health.

Any test that fits this definition must be ordered by a doctor, just like a prescription drug, so offering them online – without a doctor's involvement – would be considered illegal.

Checking genetic tests against the first three parts of this very broad definition, it's not difficult to see why California's public health department feels that it can (and should) regulate genetic testing:

1) spit, a biological specimen, is collected

2) spit contains DNA

3) genetic testing companies measure and analyze the DNA against known genetic variations

The real question, then, is only on the final component: Do genetic testing companies provide information that could be construed as aiding the prevention of a disease?

Is providing a personalized genetic risk assessment based on scientifically published genetic correlation studies an aid to the prevention of, say, colon cancer?

23andMe, for example, has argued that the testing they provide isn't a prevention aid, but merely offers "individuals contextual information about their genetic makeup, including ancestry and applicable scientific research."

Whether or not 23andMe will ultimately be able to wiggle away from regulation with this article remains to be seen. If they can, they'd find themselves with a much easier time going direct to consumers than other companies.

For example, Navigenics' website promises that the company provides "analysis of your predisposition for a variety of common conditions, and the information, support and guidance to know what steps you can take to prevent, detect or diagnose them early."

Given that description, it would be difficult for the company to argue that its tests shouldn't be regulated as clinical laboratory tests. And indeed, the company seems to have planned to be subject to the clinical laboratory test regulations. That said, the company's CEO expressed surprise to Wired.com at the aggressiveness of the California regulation. Navigenics is currently in the midst of preparing their response to the health department's cease-and-desist letter.

One intriguing legal possibility is that one or more of the companies could sue to have the lab regulation's application to genetic testing struck down. Thomas Goetz argued on these virtual pages, "My DNA is my data," and it would be a fascinating case to see if the state's court system would agree.

We haven't heard of any direct precedent to guide the courts, but it's possible that the right to privacy, which guarantees a woman's right to choose, could be applied to the genetic testing realm. The argument would be that if it's inside your body – be it a baby or DNA – the decisions relating to it are yours alone to make, without the interference of the state.

A less interesting, but perhaps faster and more effective option for the genetic testing industry would be to lobby the California legislature to turn some subset of genetic tests into explicitly over-the-counter tests like those for pregnancy or paternity.

Image: Esthr/Flickr. This image shows the karotype, or "genetic architecture," of Ryan Phelan, the CEO of DNA Direct, a genetic-testing company that was not sent a cease-and-desist letter by the state of California.

See Also:

WiSci 2.0: Alexis Madrigal's Twitter , Google Reader feed, and webpage; Wired Science on Facebook.