More on the Breast Cancer Specific Molecular Prognostic Test
MedSun: Newsletter #13, March 2007
The February 2007 issue of MedSun News featured the announcement by the Food and Drug Administration (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety of FDA clearance of a first-of-a-kind medical device that determines the likelihood of recurrence of breast cancer within 5 to 10 years after a woman's initial cancer. The following details on the MammaPrint® test may be of interest to readers.
The MammaPrint® test assesses the risk of distant metastasis for female breast cancer patients under 61 years of age with Stage I or Stage II disease, with tumor size = 5.0 cm, and who are lymph-node negative. The test uses microarray technology to measure the level of gene expression of 70 genes that regulate cell cycle, invasion, metastasis, and angiogenesis. The gene expression information from these 70 genes is combined to yield a “score” that indicates whether the patient is in a “low-risk” or “high-risk” category for metastatic recurrence of cancer.
The score was developed based on an initial study of 78 patients, was then evaluated in a second study with 151 patients, and was further validated in another study using 302 patients from five different centers in Europe. High-risk patients have a 22 percent probability of distant metastasis at 5 years, compared to 29 percent at 10 years. On the other hand, low-risk patients have a 95 percent probability of not getting metastatic disease at 5 years compared to 90 percent at 10 years.
The MammaPrint® test is not intended for diagnosis, or to predict or detect response to therapy, or to select the optimal therapy for patients. A special control guidance will be issued soon by FDA to describe types of information needed for other manufacturers to offer similar FDA-cleared tests.
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