October 9th, 2008
How closely to regulate consumer medical tests?
The question of regulating consumer medical tests is very much in the news today. (Picture of an ovarian cancer support ribbon from Woman of Teal.)
The story of LabCorp’s OvaSure, a test for ovarian cancer, is straightforward. The FDA questions its accuracy, it has not approved the test, and sent a letter to its maker because it’s still marketing the test.
The test, developed at Yale, measures the level of six proteins in a woman’s blood, then calculates the chance she has cancer.
There are two sides here. Ovarian cancer is hard to detect, it runs in families, and it’s hard to treat unless it’s detected very early. Want to lose a loved one who could have been saved?
On the other hand, do you want a hysterectomy after an inaccurate test? Want to watch a loved one die after a false negative?
We also have a new study being launched of genetic testing, partly-funded by Microsoft. It will use Microsoft’s HealthVault Personal Health Record system.
This concept is much in the news lately, and our audience is sharply divided in whether knowing genetic risks is a good thing.
Still, this is already becoming a consumer market, and there is a new science of predictive health that says you can mitigate your risk, and have a better chance of being cured, through widespread genetic testing.
The door is being looked at, in other words, while the barnyard door is wide open.
So how closely should the government be regulating medical tests that are marketed to consumers? Are warnings good enough? Or is it time for stricter controls?
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
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