FDA Approves MammaPrint Test

[Lolly]

FDA Clears Breast Cancer Specific Molecular Prognostic Test

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01555.html

The U.S. Food and Drug Administration (FDA) today cleared for marketing a test that determines the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer. It is the first cleared molecular test that profiles genetic activity.
The MammaPrint test uses the latest in molecular technology to predict whether existing cancer will metastasize (spread to other parts of a patient's body). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of behavior of large numbers of genes in biological specimens.

[AlaskaAngel]

Hi Lolly,

This gives the US cost and contact info, and indicates that fresh tumor tissue is what is required for the test:

http://www.bioinfo-online.net/modul...php?storyid=134 (http://www.bioinfo-online.net/modules/news/article.php?storyid=134)
AlaskaAngel

[Lolly]

Thanks, Alaska; It seems pretty spendy all right. I still have a hard time with "sticker shock" as it relates to BC care, as when I was first diagnosed I didn't have insurance. I know there are women out there (I've talked to a few) in that same leaky boat and it's no consolation to hear "insurance will cover it"...

However, if ever there was a necessary but spendy test, this is it! I'm especially cheered by this paragraph in the link you posted;

"...The 70 genes in a woman's tumor analyzed by MammaPrint® predict the *10-year survival of the patient at a significance level over three times greater than existing methods and with an accuracy level of 96.7% as determined by a study published in the New England Journal of Medicine. MammaPrint® also identifies those untreated individuals who have a poor tumor signature - with a high risk for metastasis if untreated..."
*emphasis added by me*

<3 Lolly

[Lolly]

Now I have to temper my enthusiasm with this caution taken from the article posted by Julie2 on the main board:

"...Indeed, the MammaPrint is much better at predicting who isn't likely to relapse than who is, Gutman said. He cited studies suggesting that when the MammaPrint predicts a woman is at high risk of cancer returning in five years, it will be right just a quarter of the time. That compares with 95 percent accuracy if the woman is told she's at low risk of a relapse.
"This information has to be used very carefully by physicians," Gutman said. "This is a complex test. It requires use by people who know their business."

The FDA has no information on whether the test results actually helped improve the survival of high-risk women, Gutman said."
http://news.yahoo.com/s/ap/20070206/ap_on_he_me/breast_cancer_test

[gdpawel]

The genetic analysis of MammaPrint predicts which women will have a greater chance of breast cancer recurrence. The test looks at the expression of 70 genes linked to breast cancer with an accuracy level of 96.7% as determined by a study published in the New England Journal of Medicine. Until this test, it had been difficult to pinpoint which women would benefit most from chemotherapy, and those which wouldn't.

This new gene expression profiling test enables the oncologist and breast cancer surgeon to more accurately determine who should be treated and who should not be treated with chemotherapy, but they cannot predict chemo response.

This laboratory test is a tool for the oncologist. The oncologist should take advantage of all the tools available to him/her to treat a patient. And since studies show that only 25-30% of patients do respond to chemotherapy that is available to them (and even less for "targeted" drugs), there should be due consideration to looking at the advantage of molecular and cellular assay tests to the resistance that has been found to chemotherapy drugs.

This test can enhance the ability to distinguish between "low" risk and "high" risk patients. Patients in the high-risk group, who would benefit from chemotherapy can then be pre-tested with a "functional" bio-marker (a cell-based assay using an EGFRx™ Anti-Tyrosine Kinase Profile) to see what treatments have the best opportunity of being successful, and offers a better chance of tumor response resulting in progression-free survival, while those in the lower-risk groups can be spared the unnecessary toxicity, particularly associated with ineffective treatment.

New anti-cancer drugs selectively "targets" cells within the body that have a specific molecular defect that is believed to cause dangerous cell behaviors such as uncontrolled proliferative growth and high metastatic potential, behaviors that are associated with aggressive cancer. The defect occurs within the interior of the cell in a region that is called the tyrosine kinase domain and it involves a complicated chemical process called EGFR signaling.

The drugs are called anti-EGFR drugs or tyrosine kinase inhibitors. When the drugs work, they can be highly beneficial, causing tumor shrinkage or promoting stable disease and extending survival. However, targeted therapy drugs like tyrosine kinase inhibitors only work for a small percentage of the patients who receive them. Further, the drugs are expensive and have been associated with toxic side effects. No molecular (gene-based) test has been proven to tell reliably who will benefit from anti-EGFR treatment.

The EGFRx™ Anti-Tyrosine Kinase Profile assay can prospectively report to a physician specifically which chemotherapy agent would benefit a high risk cancer patient by testing that patient's "live" cancer cells. Drug sensitivity profiles differ significantly among cancer patients even when diagnosed with the same cancer. Knowing the drug sensitivity profile of a specific cancer patient allows the treating oncologists to prescribe chemotherapy that will be the most effective against the tumor cells of that patient.

Every breast cancer patient should have her own unique chemotherapy trial based on consultation of pathogenic profiles and drug sensitivity testing data. Research and application of these tests are being encouraged by growing patient demands, scientific advances and medical ethics. These tests are not a luxury but an absolute necessity, and a powerful strategy that cannot be overlooked.

These new genetic and cellular-based tests have enormous implications for the short-term future of cancer research in general, and is one of the truly great cancer breakthroughs of our time.

http://weisenthalcancer.com/Patient%20Pages/EGFRXPatients.htm