The Molecular Profiling Institute named US provider of genetic breast cancer test
MammaPrint® provides prognostic information for women with early invasive breast cancer
Phoenix, AZ, December 8, 2004--The Molecular Profiling Institute (MPI), today announced that it is the sole source provider in the United States for MammaPrint®. MammaPrint® is a prognostic test developed by Agendia that helps identify how a breast cancer patient's tumor will behave. MPI in collaboration with the Netherlands-based Agendia, and AmeriPath will offer MammaPrint® through physician referral to breast cancer patients nationwide beginning in January 2005.
MammaPrint® employs gene expression profiling to assess the recurrence risk in breast cancer patients. Oncologists receive detailed prognostic information on women with primary invasive breast cancer aged 55 years or younger who are lymph node negative with either a positive or negative estrogen receptor status. Taken together with a patient's clinical information this test may provide valuable assistance for oncologists in formulating tailor-made treatment plans.
Approximately 70 percent of the 250,000 patients diagnosed annually with breast cancer are stage I and II. Nearly 50 percent of affected women are under age 60. The test has the potential to add positively to the clinical decisions influencing nearly 70,000 breast cancer patients per year.
Using the MammaPrint® microarray assay, MPI can determine which genes are expressed in a breast cancer patient's tumor. The tumor is then classified as "good" prognosis or "poor" prognosis. The results allow oncologists to implement a more effective and personalized treatment plan.
Typically, oncologists use several clinical factors --age, estrogen receptor status, tumor size and grade-- to determine how a patient's tumor will behave and how best to intervene. When compared to these clinical factors, the MammaPrint® test has been shown to provide the most comprehensive prognostic information assessing the development of future metastases.
A patient-tailored treatment plan based on the genetics of the tumor combined with standard prognostic information enables physicians to more accurately define patients who will benefit from therapy.
"We believe that the MammaPrint® test will provide an important first step for physicians to ultimately bring personalized medicine to the nation's breast cancer patients," said Robert J. Penny MD, PhD, President and CEO of MPI.
Large-scale prospective clinical trials of MammaPrint® are currently underway led by the Netherlands Cancer Institute in some 10,000 breast cancer patients to further validate the breast cancer prognosis signature.
"We are very excited with the external validation of the MammaPrint® test by six independent medical centers," said Dr. Bernhard Sixt, CEO and co-founder of Agendia. "Our strategic partnership with MPI will ensure that US patients and the medical community have access to MammaPrint®."
Additionally, MPI and AmeriPath have formed a partnership where AmeriPath's pathologist network will have access to the molecular profiling provided by MPI. AmeriPath will use MPI as their advanced esoteric reference lab.
"AmeriPath's partnership with MPI will allow our pathologists to continue to be national leaders in the delivery of premier diagnostic testing and healthcare information to the 3.5 million community of patients that we serve," said Jeffrey Mossler, MD, Chief Medical Officer of AmeriPath.
The MammaPrint® test will be available in January 2005. MPI is the sole provider of MammaPrint® in the United States. For further information regarding MammaPrint® contact MPI at 602-358-8900 or www.molecularprofiling.com.
This test was developed and its performance characteristics determined by Agendia. It has not been cleared or approved by the US Food and Drug Administration. The FDA ha determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. The laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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