This new gene expression profiling test enables the oncologist and breast cancer surgeon to more accurately determine who should be treated and who should not be treated with chemotherapy, but they cannot predict chemo response.

This laboratory test is a tool for the oncologist. The oncologist should take advantage of all the tools available to him/her to treat a patient. And since studies show that only 25-30% of patients do respond to chemotherapy that is available to them (and even less for "targeted" drugs), there should be due consideration to looking at the advantage of molecular and cellular assay tests to the resistance that has been found to chemotherapy drugs.

This test can enhance the ability to distinguish between "low" risk and "high" risk patients. Patients in the high-risk group, who would benefit from chemotherapy can then be pre-tested with a "functional" bio-marker (a cell-based assay using an EGFRx™ Anti-Tyrosine Kinase Profile) to see what treatments have the best opportunity of being successful, and offers a better chance of tumor response resulting in progression-free survival, while those in the lower-risk groups can be spared the unnecessary toxicity, particularly associated with ineffective treatment.

New anti-cancer drugs selectively "targets" cells within the body that have a specific molecular defect that is believed to cause dangerous cell behaviors such as uncontrolled proliferative growth and high metastatic potential, behaviors that are associated with aggressive cancer. The defect occurs within the interior of the cell in a region that is called the tyrosine kinase domain and it involves a complicated chemical process called EGFR signaling.

The drugs are called anti-EGFR drugs or tyrosine kinase inhibitors. When the drugs work, they can be highly beneficial, causing tumor shrinkage or promoting stable disease and extending survival. However, targeted therapy drugs like tyrosine kinase inhibitors only work for a small percentage of the patients who receive them. Further, the drugs are expensive and have been associated with toxic side effects. No molecular (gene-based) test has been proven to tell reliably who will benefit from anti-EGFR treatment.

The EGFRx™ Anti-Tyrosine Kinase Profile assay can prospectively report to a physician specifically which chemotherapy agent would benefit a high risk cancer patient by testing that patient's "live" cancer cells. Drug sensitivity profiles differ significantly among cancer patients even when diagnosed with the same cancer. Knowing the drug sensitivity profile of a specific cancer patient allows the treating oncologists to prescribe chemotherapy that will be the most effective against the tumor cells of that patient.

Every breast cancer patient should have her own unique chemotherapy trial based on consultation of pathogenic profiles and drug sensitivity testing data. Research and application of these tests are being encouraged by growing patient demands, scientific advances and medical ethics. These tests are not a luxury but an absolute necessity, and a powerful strategy that cannot be overlooked.

These new genetic and cellular-based tests have enormous implications for the short-term future of cancer research in general, and is one of the truly great cancer breakthroughs of our time.

http://weisenthalcancer.com/index.htm *** Edited 12/9/2007 12:50:45 AM UTC by gdpawel***

The Molecular Profiling Institute Launches Mammostrat: A Novel, Molecular Targeted, Prognostic Test For Breast Cancer Patients

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."

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.

The Molecular Profiling Institute, Inc.

http://www.molecularprofiling.com