Next-Generation Genomic Tests Determine Molecular Subtypes and Risk of Recurrence, Providing More Precise Prognosis and Treatment
IRVINE, CA and AMSTERDAM, THE NETHERLANDS, January 30, 2014 – Molecular subtyping provides a more precise prognosis and valuable guidance about the best treatment for early-stage breast cancer, according to a presentation by Neil Barth, M.D., at the prestigious Personalized Medicine World Conference (PMWC). Dr. Barth, a medical oncologist and Chief Medical Officer of Agendia, was a featured speaker at the recently concluded conference.
Agendia’s BluePrint® molecular diagnostics assay is the most widely available test providing molecular subtyping of individual breast cancers. It is performed as part of the Symphony® test panel. Symphony also includes MammaPrint®, the first FDA-cleared test of its kind and the only one providing risk recurrence information that is based on prospective trials including patient outcome data (e.g., the RASTER study).
The conference drew more than a thousand leading clinical and industry participants to focus on how personalized medicine is changing cancer care. Dr. Barth’s talk, “Molecular Subtypes: The Changing Face of Cancer Management,” outlined how BluePrint and MammaPrint greatly improve the physician’s ability to personalize treatment to the specific biology of each breast cancer.
“Molecular subtyping provides us more information about each individual patient’s breast cancer than is available from traditional biomarkers,” Dr. Barth said. “By combining the information from BluePrint and MammaPrint, we can better predict the benefits of therapy. This means we can personalize treatment and in some cases confidently assure patients they can avoid chemotherapy, and the side-effects that go with it, because other therapies will be more effective.”
MammaPrint provides definitive High Risk or Low Risk information about breast cancer recurrence, without ambiguous “intermediate” results. The BluePrint test, building on the foundational prognostic precision of MammaPrint, classifies breast cancer into one of four molecular subtypes: Luminal A, Luminal B, HER2-type, and Basal-type. BluePrint also provides information about neoadjuvant chemosensitivity (that is, responsiveness to chemotherapy) more accurately than does an IHC/FISH assessment.
Among the research studies cited by Dr. Barth was one presented at the recent San Antonio Breast Cancer Symposium by Massimo Cristofanilli, M.D., Director of the Breast Care Center at Thomas Jefferson University Hospitals. Ann Meredith, an executive at a Philadelphia-area nonprofit and a patient of Dr. Cristofanilli’s, was one of the patients who has benefited from the new diagnostics. Her initial oncologist recommended her breast cancer be treated with chemotherapy and radiation, and she gave serious consideration to having a double prophylactic mastectomy.
After consulting with Dr. Cristofanilli and receiving the MammaPrint and BluePrint tests, however, she learned she had a Luminal A molecular subtype of breast cancer. That meant she had a low risk of recurrence and did not need to undergo chemotherapy or a mastectomy.
Meredith said receiving a personalized diagnosis gave her peace of mind that she and Dr. Cristofanilli made the right treatment decisions, and that she can move on with her life without unnecessary concern about her cancer recurring. “My treatment was not cookie cutter,” she said. “The MammaPrint and BluePrint tests changed the recommendations on whether to do chemotherapy and whether I should have mastectomy or a breast-conserving lumpectomy.”
Symphony, Agendia’s suite of genomic tests that includes MammaPrint and BluePrint, is the only predictive, multi-gene breast cancer panel that is validated in prospective trials including outcome data. The Agendia tests have substantial insurance coverage encompassing an estimated 170 million lives and including coverage by Medicare and regional and national insurers.
The PMWC conference was held Jan. 27-28 in Mountain View, Calif.
Agendia is a leading molecular diagnostic company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint, a molecular subtyping assay, and TargetPrint®, an ER/PR/HER2 expression assay. Together, these tests help physicians determine a patient’s individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.
In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials. For more information, visit www.agendia.com.
Liz Dowling (Medical & Consumer Media)
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