Agendia, a provider of molecular cancer diagnostics, has reported that its breast cancer product offering, consisting of breast cancer recurrence test MammaPrint and TargetPrint, has been expanded with BluePrint to report important additional information on tumor subtypes.
The new service is based on an 80-gene signature that identifies the basal-like, luminal-like, and HER2 molecular subtypes in breast cancer tumors.
MammaPrint is the breast cancer recurrence test cleared by the 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.
Agendia claimed that the MammaPrint is accurate and 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.
Agendia said that all MammaPrint tests are conducted in its CLIA-accredited service laboratory. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the FDA clearance process.
Richard Bender, chief medical officer of Agendia, said: “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. We believe this combination has great potential to bring the personalized treatment of breast cancer patients to a new level.”