The Molecular Profiling Institute Launches Mammostrat(TM) A Novel, Molecular Targeted, Prognostic Test For Breast Cancer Patients
Main Category: Breast CancerAlso Included In: Women's Health / Gynecology; IT / Internet / E-mail
Article Date: 06 Sep 2007 - 0:00 PDT
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The Molecular Profiling Institute, Inc. (Molecular Profiling) announced that they are now providing Mammostrat, a new molecular-targeted breast prognostic test, to breast cancer patients, nationwide. The Mammostrat prognostic test utilizes five immunohistochemical (IHC) biomarkers to classify patients into high, moderate, or low-risk categories for disease recurrence.
Robert Penny, M.D., Ph.D., the Chairman and CEO of the Molecular Profiling Institute stated, "Mammostrat will benefit the care of breast cancer patients nationwide by allowing their cancer to be quickly analyzed for prognosis by a direct light-microscopic evaluation of the cancer cells by a pathologist. This new test, which is performed on tissue preserved according to standard practice, streamlines the process for patients while providing the accuracy of direct visualization."
The test was developed by Applied Genomics, Inc. who rigorously translated recent genomic insights in cancer into a novel immunohistochemistry test. Mammostrat test results have been validated using over a thousand patient samples in North America from clinics/organizations such as the Cleveland Clinic Foundation and the National Surgical Adjuvant Breast and Bowel Project -- generating results with clear cut conclusions from multiple independent studies supporting the prognostic value of the test.
"We are excited to have partnered with the Molecular Profiling Institute, says Doug Ross, MD, PhD, Chief Scientific Officer of Applied Genomics. "Their expertise in advanced genomic and proteomic testing will provide a rigorous reference lab-based introduction of the test and broad reach in order to offer quality testing to patients nationwide."
Because Mammostrat uses traditional immunohistochemistry technology, the test is expected to be significantly less expensive than existing molecular-based, prognostic tests for breast cancer and is typically covered by insurance. Todd Maney, Ph.D., Vice President of New Product Development, MPI, stated, "Mammostrat's cost-effective, molecular-targeted analysis enables MPI to provide the test at a significant discount compared to our competitors. Moreover, test results will be available quickly -- an average of seven business days -- versus two weeks for alternative, comparable tests."
Physicians may order the Mammostrat test direct from the Molecular Profiling Institute or through their distribution partner AmeriPath by visiting http://www.molecularprofiling.com.
About the Molecular Profiling Institute, Inc. -- Molecular Profiling is a CLIA-certified specialty reference laboratory that helps 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 complex diseases, and pharmaceutical services to identify populations that may respond to targeted therapies. Molecular Profiling leverages strategic relationships with a number of organizations, including AmeriPath, Inc., the International Genomics Consortium (IGC), and the Translational Genomics Research Institute (TGen). Molecular Profiling's Web site address is http://www.molecularprofiling.com.
About Applied Genomics -- Applied Genomics, Inc. develops targeted diagnostics to improve treatment for cancer patients. Translating insights from genomic analyses of cancer, AGI creates antibody-based diagnostic tests for classifying cancer facilitating rational patient care decisions and improving quality of life for all patients. AGI has ongoing product development programs in breast, lung, ovarian, head and neck, and colon cancer. Additional company information is available at: http://www.applied-genomics.com.
The Molecular Profiling Institute, Inc.
http://www.molecularprofiling.com
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Mammostrat: Another Molecular Test
posted by Gregory D. Pawelski on 2 Dec 2007 at 1:46 pmIn principle, this makes more sense than the Oncotype DX test. It is "validated" with the usual, retrospective, non-randomized study using archival tissues and uniform batch processing and slide interpretation.
In chemotherapy selection, Gene and Protein testing examine a single process within the cell or a relatively small number of processes. The aim is to tell if there is a theoretical predisposition to drug response.
Whole Cell Functional Profiling tests not only for the presence of genes and proteins but also for their functionality, for their interaction with other genes, proteins, and processes occurring within the cell, and for their response to anti-cancer drugs.
Genes create the blueprints for the production of proteins within the cell. A protein is a molecule that makes a cell behave in a certain way. It does so by interacting with other proteins in a complex series of steps.
The goal of Gene testing is to look for patterns of normal and abnormal gene expression which could suggest that certain proteins might or might not be produced within a cell. However, just because a gene is present it does not mean that an associated protein has been produced.
Protein testing goes one step further by testing to see if the relevant protein actually has been produced. However, even Protein testing cannot tell us if a protein is functional or how it will interact with other proteins in the presence of anti-cancer drugs.
Gene and Protein testing involve the use of dead, formaldehyde preserved cells that are never exposed to chemotherapy drugs. Gene and Protein tests cannot tells us anything about uptake of a certain drug into the cell or if the drug will be excluded before it can act or what changes will take place within the cell if the drug successfully enters the cell.
Gene and Protein tests cannot discriminate among the activities of different drugs within the same class. Instead, Gene and Protein tests assume that all drugs within a class will produce precisely the same effect, even though from clinical experience, this is not the case. Nor can Gene and Protein tests tell us anything about drug combinations.
"Whole Cell" Functional Tumor Cell Profiling tests living cancer cells. Functional Tumor Cell Profiling assesses the net result of all cellular processes, including interactions, occurring in real time when cancer cells actually are exposed to specific anti-cancer drugs. Functional Tumor Cell Profiling can discriminate differing anti-tumor effects of different drugs within the same class. Functional Profiling can also identify synergies in drug combinations.
Gene and Protein tests are better suited for ruling out "inactive" drugs than for identifying "active" drugs. When considering a cancer drug which is believed to act only upon cancer cells that have a specific genetic defect, it is useful to know if a patient's cancer cells do or do not have precisely that defect.
Although presence of a targeted defect does not necessarily mean that a drug will be effective, absence of the targeted defect may rule out use of the drug. Of course, this assumes that the mechanism of drug activity is known beyond any doubt, which is not always the case.
Although Gene and Protein testing currently are limited in their reliability as clinical tools, the tests can be important in research settings such as in helping to identify rational targets for development of new anti-cancer drugs.
As you can see, just selecting the right test to perform in the right situation is a very important step on the road to personalizing cancer therapy.
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