Posted on 02/08/2007 12:22:39 AM PST by neverdem
A new genetic test that tries to predict whether a woman with breast cancer will have a relapse won approval yesterday from the Food and Drug Administration, marking a step toward an era in which medical treatments are personalized for each patient.
The approval was the first ever of such a complex genetic test, not only the first for breast cancer relapse.
While other breast cancer recurrence predictive tests are being sold or developed, the new one, called MammaPrint, is the first to go through the formal F.D.A. approval process. The agency has signaled its intention to oversee more closely a profusion of sophisticated diagnostic tests that until now have often been marketed without its blessing.
The test is not totally accurate. “You can’t go all the way to the bank with this information,” said Dr. Steven Gutman, the F.D.A. official in charge of diagnostic tests, in a conference call with reporters. Still, he said, “I think it’s a fabulous tool and one that needs further study.”
MammaPrint, developed by scientists in the Netherlands, examines the pattern of activity of 70 specific genes in a breast tumor after it is removed by surgery.
Dr. Gutman said that 23 percent of women deemed by this genetic signature to be at high risk actually had a recurrence of cancer somewhere in the body within five years. Only about 5 percent of those with a favorable genetic signature had a return of cancer in that time, he said.
Agendia, a company based in Amsterdam that already offers the test in its own country and some others, is considering how to make the test available to Americans, its chief executive, Bernhard Sixt, said in an interview.
(Excerpt) Read more at nytimes.com ...
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Great news, thanks for posting!
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