Agendia announced the inclusion of its breast cancer recurrence test MammaPrint in St. Gallen’s 2009 International Expert Consensus on the primary therapy of early breast cancer.

The St. Gallen expert panel consists of key opinion leaders from across Europe (53%), the US (33%), and rest of the world (14%). In the recently published article highlighting the 2009 recommendations, the panelists emphasize that “in an important change from the previous St. Gallen conference … the Panel supported the use of a validated multigene-profiling assay, if readily available, as an adjunct to high-quality phenotyping of breast cancer in cases in which the indication for adjuvant chemotherapy remained uncertain.

In addition, the panel cautioned that so-called intermediate scores are not useful in clinical decision making. Currently, MammaPrint is the only breast cancer recurrence assay available that accurately yields a binary result, without an intermediate group, addressing the panel’s recommendations. The FDA-cleared assay is always clinically useful and indicates whether a patient is at low or high risk for metastasis and the resulting clarity is vital in helping physicians personalize treatment options.

St. Gallen’s guideline inclusion is a key step in further establishing MammaPrint as a standard of care. It also supports our commitment to upholding rigorous standards of quality and efficacy,” said Dr. Bernhard Sixt, Agendia’s President and Chief Executive Officer. “With MammaPrint we aim to provide breast cancer patients and their physicians with definitive answers to crucial treatment questions.”