MammaPrint DNA microarray

[gpawelski]

Another new test, that looks at the expression of 70 genes linked to breast cancer, can accurately assess a patient's risk of recurrence or death. The correlations of this are vastly superior to those obtained with standard prognostic markers.

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.

Existing methods can't distinguish the patients with a high risk for recurrence from those with low risk with comparable accuracy. This new gene expression profiling test enables the oncologist and breast surgeon to more accurately determine who should be treated.

This test has been shown to be superior over conventional assessment of risk of future metastatic disease, such as histological assessment of tumor aggressiveness (by grade). One gets more accurate information when using intact RNA isolated from "fresh" tissue than from using degraded RNA, which is present in paraffin-fixed tissues.

For the vast majority of cancer patients, the cancer will not recur regardless of whether they receive chemotherapy. So they are exposed needlessly to the treatment, which can cause myelosuppression, mucositis, cardiac problems, peripheral neuropathy, central neurotoxicity, or leukemia. Doctors cannot tell, however, which patients needed the chemotherapy.

These laboratory tests are 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, 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.

Because of this, there is a good portion of cancer patients that are either undertreated or overtreated because there was no adequate information on who will recur. These tests 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 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.

These 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. This DNA microarray will prove to be highly complementary to the parellel breakthrough efforts in targeted therapy through cell culture assays like the EGFRx? Assay.

Cell Culture Assays 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.

[gpawelski]

In 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.

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