SUN EDITORIAL:

Predicting future health

FDA should expand regulation of genetic testing to protect consumers

Saturday, Oct. 11, 2008 | 2:06 a.m.

Advances in genetic research have caused our health care system to be flooded with tests that are designed to let patients know whether they are predisposed to particular diseases. The concept is sound. A patient warned years in advance of a potential disorder may have time to prevent the onset of a disease that, if left unchecked, could be fatal.

That is the hope of Decode Genetics, an Icelandic biotech company that devised a test it says can detect whether a woman is at risk of contracting common forms of breast cancer. But as reported Wednesday by The Washington Post, the $1,625 test has renewed a debate over the value of genetic tests that are not regulated by the Food and Drug Administration.

The FDA regulates genetic test kits that are developed by one company and performed by multiple laboratories. But the FDA does not regulate tests such as Decode’s that are developed and performed by a single clinical lab, which are known as “home brews.”

Decode’s chief executive, Kari Stefansson, told the Post the test “will most definitely save lives,” a fact he said was verified by studies involving nearly 100,000 women. But because there has been no independent verification by the FDA or any other American organization, patients and their physicians are relying on the company’s word. And that, some researchers say, could give a woman false assurances that she will not contract breast cancer when that might not be the case.

The FDA ought to validate all genetic tests so that consumers and doctors can make intelligent decisions about whether the tests are appropriate. Any laboratory should be willing to consent to this and, in fact, welcome it, because a passing grade would be terrific news for its tests.

Because genetic tests are available for more than 1,200 conditions and are becoming more popular, it makes sense to regulate all of them before we have a situation where patients could be harmed by false results.