Agendia Launches BluePrint(TM) Expanding Breast Cancer Product Offering
"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."
About MammaPrint(R)
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.
Source: Agendia
