At-Home Gene Tests Under Fire

June 26, 2008 — -- A new generation of at-home tests promises to give you a glimpse of your future by looking at your genes — maybe even predicting your chances of getting cancer, diabetes or heart disease.

But the growing new industry is facing hurdles, as experts express fears the commerce may be ahead of the science, and a number of direct-to-consumer genetic testing companies are being questioned by state and federal regulators.

The California Department of Public Health has sent "cease and desist" letters to at least a dozen genetic testing companies, telling them they cannot solicit business from state residents.

Meanwhile, the Federal Trade Commission has started investigations into potentially deceptive advertising or marketing of genetic tests.

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Dr. Francis S. Collins, a geneticist renowned for his landmark discoveries of disease genes who is director of the National Human Genome Research Institute, is torn about how to feel about the new industry.

"I think this is both an exhilarating moment in terms of the opportunities to really begin to learn about our own personal risks of future diseases and have a chance to practice better prevention in an individualized way instead of doing one-size-fits-all medicine," Collins says. "But, it is very early, and I think people [who] consider having these kinds of tests ought to really be clear about the fact that while the tests may give information … it's not 'yes' or 'no.' It's a statistical risk."

But whether or not those reservations are common knowledge, the companies already are up and running.

Navigenics, a California Web-based company, launched its $2,500 personalized DNA test in April — promising to tell consumers their potential genetic predisposition for 19 different conditions influenced by multiple genes, including multiple sclerosis, breast cancer, type 2 diabetes and lupus.

The customer orders a kit online and is instructed to spit into a test tube and send it into a lab. Then, Navigenics scans nearly one million DNA snippets and hones in on markers associated with the 19 conditions.

Dr. David Agus, the founder of the company, says the company's goal is to eliminate the doctor's role as the sole gatekeeper of medical information.

"Were really putting you in charge of your own health care," Agus says. "We're allowing you to focus where your energies are to the disease you may get and really try and prevent it."

For example, the companies argue, if you find out you have a potentially higher risk for getting colon cancer, you can take action with preventative colonoscopies for early detection. If you have a higher genetic risk for heart disease, you might start taking a drug, like Lipitor.

"The medical community shouldn't be out there saying we're going to decide when its ready for you," Agus says. "You should look at the data yourself with your physician and your family and your value system and together make a decision."

But Collins says customers are getting predictions, not necessarily medical recommendations or prescriptions about what to do about the information.

Some experts also are critical that the tests do not take into account lifestyle and environmental factors, which play a major role in whether someone will actually get a disease.