The Molecular Profiling Institute, Inc. launches MammaPrint® for breast cancer patients

04/21/05

More accurately identifying treatment needs according to the tumor's DNA profile

Phoenix, AZ April 21, 2005 - The Molecular Profiling Institute, Inc. (MPI) announced today that it is now providing the MammaPrint® breast cancer test to breast cancer patients in the United States. This is the first commercially available microarray cancer diagnostic that analyzes patients' breast tumors for their individual DNA expression profile.

"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.

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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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