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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, 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. Molecular Profiling 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, Molecular Profiling 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 next step for physicians to further personalized medicine to the nation's breast cancer patients," said Robert J. Penny MD, PhD, President and CEO of Molecular Profiling.
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 Molecular Profiling will ensure that US patients and the medical community have access to MammaPrint®."
Additionally, Molecular Profiling and AmeriPath have formed a partnership where AmeriPath's pathologist network will have access to the molecular profiling provided by Molecular Profiling. AmeriPath will use Molecular Profiling as their advanced esoteric reference lab.
"AmeriPath's partnership with Molecular Profiling 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. Molecular Profiling is the sole provider of MammaPrint® in the United States. For further information regarding MammaPrint® contact Molecular Profiling at (602) 358-8900 or www.molecularprofiling.com.
This test was developed by Agendia BV and its performance characteristics determined by Agendia BV and the Molecular Profiling Institute, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Molecular Profiling is certified and Agendia BV is registered under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. The FDA is evaluating the registration status of this test.
This test is believed to be a useful adjunct in evaluating the prognosis for patients with cancer. Decisions regarding care and treatment should not be based on a single test such as this test. Rather decisions on care and treatment should be based on the independent medical judgment of the treating physician taking into consideration all available information concerning the patient's condition, including other pathological tests, in accordance with the standard of care in a given community.
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About Molecular Profiling
The Molecular Profiling Institute, Inc. is a specialty reference laboratory that helps cancer patients worldwide by applying the discoveries of the Human Genome Project to personalized medicine. Molecular Profiling provides cutting-edge testing facilities, products, and resources for genomic and proteomic profiling and treatment of cancers. The Molecular Profiling Institute, Inc., has strategic relationships with the Translational Genomics Research Institute (TGen) and Ameripath.
About Agendia
Agendia was established in 2003 to develop new prognostic tools, based on gene expression profiling, to be used in oncology. Agendia has its roots in the Netherlands Cancer Institute, an internationally renowned cancer research center. Agendias first commercialized product is a breast cancer prognostic test called MammaPrint®. The company, located in Amsterdam, The Netherlands, has a high quality laboratory for patient testing. Several large-scale clinical studies are ongoing in hospitals in Europe and the US to further validate MammaPrint® in a large and diverse patient population. For additional information, please visit the Agendia web site at www.agendia.com
Media Contact:
Galen Perry at (602) 377-4734 mobile (602) 343-8423 voice
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