New Service to Provide Breast Cancer Molecular Subtyping
HUNTINGTON BEACH, California and AMSTERDAM, March 24, 2010 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced that its breast cancer product offering, consisting of breast cancer recurrence test MammaPrint(R), and TargetPrint(TM), has been expanded with BluePrint (TM) to report important additional information on tumor subtypes. This new service is based on an 80-gene signature that identifies the basal-like, luminal-like, and HER2 molecular subtypes in breast cancer tumors.
"Using BluePrint, we will research potentially different responses of therapies to biologically different subgroups together with our customers. In the future, we envision the clinical utility of a combination of BluePrint with MammaPrint's original 70-gene panel," said Richard Bender, MD, FACP, Chief Medical Officer of Agendia. "We believe this combination has great potential to bring the personalized treatment of breast cancer patients to a new level."
MammaPrint is the first and only breast cancer recurrence test cleared by the U.S. Food and Drug Administration (FDA). FDA clearance under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines requires clinical and analytical validation and reporting systems to ensure patient safety issues are addressed. Highly accurate, MammaPrint identifies patients with early metastasis-patients who are likely to develop metastases within five years following surgery. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test results provide doctors with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests.
All MammaPrint tests are conducted in Agendia's CLIA-accredited service laboratory. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the rigorous FDA clearance process.
Agendia is at the forefront of the personalized medicine revolution, striving to bring more effective, individualized treatments within reach of patients. Building on a cutting-edge genomics platform for tumor gene expression profiling, the company's tests help physicians more accurately tailor cancer treatments. Agendia markets four products, with several new genomic tests under development. In addition, Agendia collaborates with pharmaceutical companies to develop highly effective personalized drugs in the area of oncology. The Company was awarded the 2008 North American Oncology Clinical Diagnostics Healthcare Innovation Award by Frost & Sullivan. Agendia is based in Huntington Beach, California, and in Amsterdam, The Netherlands.
SOURCE Agendia B.V.