- The Washington Times - Tuesday, February 6, 2007

The Food and Drug Administration yesterday approved a breast cancer test that will determine the likelihood of the disease resurfacing within five to 10 years after the diagnosis.

The MammaPrint test evaluates 70 genes that play a role in the recurrence of a breast cancer tumor in women under age 61. The test predicts the chances of the tumor resurfacing at five- and 10-year periods.

It is not the first test of its kind in the U.S., but it is the first to receive approval from the FDA. The test is the first computer-derived indicator that looks at multiple genes to provide a risk score for the recurrence of breast cancer; similar devices usually measure one or two genes, according to the FDA.

“This test is an important step in our journey toward having improved personalized molecular medicine as a tool for use in making better treatment decisions,” said Steve Gutman, director of the FDA’s office of In Vitro Diagnostic Device Evaluation and Safety.

The test was developed by Agendia, a laboratory in Amsterdam where the product has been on the market since 2005.

The FDA has no information on whether the test increased the survival of breast cancer patients, Mr. Gutman said. Physicians can use it to decide whether a patient should receive chemotherapy, which is used widely to stave off resurgence after surgery or hormone treatment.

But Mr. Gutman warned it is not a perfect test. It was accurate only 23 percent of the time for women the test suggested were at “high risk” of a recurrence. He said it is much more accurate — 95 percent — at predicting if a woman is at low risk for a relapse.

The American Cancer Society predicts more than 178,000 new cases of breast cancer will be diagnosed this year among U.S. women, and more than 40,000 are likely to die from the disease.

The impact of the FDA approval is not known because similar breast cancer tests, known in the oncology arena as “home-brew” or laboratory tests, are already used by doctors. One example is a test manufactured by Genomic Health in California called Oncotype DX, which is not FDA-approved and costs about $3,000.

“To me, it means that the Agendia test has met certain standards for effectiveness,” said Len Lichtenfeld, deputy chief medical officer at the American Cancer Society. “But I’m not necessarily sure that other home-brew test companies are doing bad science.”

Tests analyzing genetic patterns in cancerous tumors may not be the first tool physicians use to make a determination on chemotherapy.

“At the end of the day, this test will be the exception rather than the rule when it comes to making a decision about chemotherapy,” Mr. Lichtenfeld said.

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