"MammaPrint® more accurately distinguishes between lymph node-negative breast cancer patients who would benefit from additional therapy from those who would not, helping oncologists offer more effective therapy to their patients. Personalized medicine is here," said Dr. Robert Penny, the President and CEO of MPI.
According to the National Cancer Institute of the National Institutes of Health (NIH)(1) and the American Cancer Society(2), 216,000 new cases of breast cancer are found annually in the United States of which 56% or 121,000 are lymph node negative and 20% of these or 24,200 will develop distant metastases and require follow on treatment.(3) However, in node-negative women under 51 years of age, 45% are treated with chemotherapy in the United States today, meaning over twice as many patients are currently treated than may actually need the therapy.(4) Additionally, of patients in the category that could benefit from treatment, a large portion are never started on therapy or receive sub-therapeutic doses.(5)
"Existing methods can't distinguish the patients with a high risk for recurrence from those with low risk with comparable accuracy," said Dr. David Alberts, Director of the Arizona Cancer Center. Currently, one of the most important prognostic indicators for the cancer recurring is the size of the tumor. However, a significant number of tumors less than one centimeter in diameter are actually high risk.
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.(6)
"This new test enables the oncologist and breast surgeon to more accurately determine who should be treated, helping us to maximize survival and decrease morbidity" said Dr. David Loesch, Physician Director for Clinical Research at the Central Indiana Cancer Centers - a leading practice offering the test. "After the diagnosis of malignancy is made, MPI's MammaPrint® Breast Cancer Test is the most important test to get."
The cost of the MammaPrint® in the US is $3,200. This covers collection and preservation of the genetic material in fresh tissue and substantial genetic microarray testing and analysis of the 70 relevant genes. MammaPrint® utilizes established reimbursement codes that are recognized by most insurance companies. "We believe this fee is reasonable considering the complexity and accuracy of the test. This amount is low compared to the economic and personal cost of unnecessary treatment or simply not treating a patient at high risk for recurrence," stated David Mallery, MPI's Executive Vice President.
MPI utilizes IBM technology and has a close partnership with AmeriPath Inc., one of the leading anatomic pathology laboratory companies in the United States. "AmeriPath's partnership with MPI allows our pathologists to continue to be national leaders in the delivery of premier diagnostic testing and healthcare information to the communities and patients that we serve," said Jeffrey Mossler, MD, Vice Chairman of AmeriPath.
MPI was developed by two non-profits, the Translational Genomics Research Institute (TGen) and the International Genomics Consortium (IGC) and has licensing agreements with these entities for new diagnostics. TGen and IGC were developed by the leaders of the Human Genome Project and include many of the top clinical oncologists in the country.
The MammaPrint® test is now widely available through MPI, the sole provider of MammaPrint® in the United States. The test was developed and is licensed from Agendia BV. For further information regarding MammaPrint® contact MPI at (602) 358-8900, 1 (800) 591-2610, or www.molecularprofiling.com.
References 1. SEER Breast Cancer Statistics Tables IV-3 and IV-7, www.seer.cancer.gov, 2005.
2. Cancer Facts and Figures, American Cancer Society, 2004, p 9 - 10.
3. Menes TS, et al, Breast cancer patients with pN0 and PN1 sentinel nodes have high rate of nonsentinel node metastases, J Am Coll Surg, 2005 Mar;200(3):323-7.
4. Harlan LC, et al, Adjuvant Therapy for Breast Cancer: Practice Patterns of Community Physicians, J Clin Onc 2002 20(7): 1809-1817.
5. Lyman GH, et al, Incidence and predictors of low dose- intensity in adjuvant breast cancer chemotherapy: A nationwide study of community practices, J Clin Onc 2003 Dec: 21(24); p4524-4531.
6. van de Vijver, et al, A gene expression signature as a predictor of survival in breast cancer, NEJM 2002 Dec: 437(25); p 1999 - 2009, finding that MammaPrint's® 70 gene signature "is a more powerful predictor of the outcome of disease in young patients with breast cancer than standard systems based on clinical and histologic criteria."
About the Molecular Profiling Institute Inc. (MPI) - MPI is a CLIA certified specialty reference laboratory that helps cancer patients worldwide by applying the discoveries of the Human Genome Project to personalized medicine. MPI provides cutting-edge testing facilities, products, and resources for genomic and proteomic profiling and treatment of cancers and pharmaceutical services to identify populations that may respond to targeted therapies. MPI has strategic relationships with the Translational Genomics Research Institute (TGen), the International Genomics Consortium (IGC), Scottsdale Healthcare, and AmeriPath Inc.
About AmeriPath Inc. - AmeriPath is one of the leading anatomic pathology laboratory companies in the United States. AmeriPath offers a broad range of testing and information services used by physicians in the detection, diagnosis, evaluation and treatment of cancer and other diseases and medical conditions. The company's extensive diagnostics infrastructure includes over 400 pathologists and doctorate-level scientists providing services in over 20 states utilizing 40 independent pathology laboratories, more than 200 hospitals, and their Centers of Excellence.
About Agendia BV - 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. Agendia's first commercialized product is a breast cancer prognostic test called MammaPrint®. MammaPrint® and Agendia are registered trademarks of Agendia BV, located in Amsterdam, The Netherlands, has a high quality laboratory for patient testing.
About IBM Healthcare & Life Sciences - IBM is the world's largest information technology company, with more than 80 years of leadership in helping businesses innovate. IBM Healthcare and Life Sciences brings together IBM resources, including information technology, deep industry insights, and research expertise, to help clients develop and deliver safer, more affordable and more effective diagnostics, drugs and medical care.
About the Translational Genomics Research Institute (TGen) - The mission of TGen is to make and translate genomic discoveries into advances in human health. TGen is focused on personalized medicine through robust and diseased-focused research programs and its state-of-the-art bioinformatics and computational biology facilities.
About the International Genomics Consortium (IGC) - IGC is a non-profit medical research foundation established to serve common, unmet needs including: the standardization of the collection of properly consented tissues of interest, the molecular characterization of these tissues, and standardization in the representation of these results.
Note About MammaPrint® - 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 has 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.