Agendia’s FFPE breast cancer test receives FDA approval

Molecular diagnostics firm Agendia has obtained 510(k) approval from the US Food and Drug Adminstrtaion for its MammaPrint breast cancer recurrence test in formalin-fixed paraffin embedded (FFPE) tissue.

The test uses the same 70 genes and proprietary algorithm as the previously cleared multi-gene medical device MammaPrint Fresh, noted Agendia.

Agendia CEO Jan Egberts said: "MammaPrint FFPE changes the conversation between physicians and patients at that critical point where treatment decisions are being made.

"The test result eliminates the ambiguity of the ‘Intermediate result’ seen in other test platforms, and in concert with other factors, facilitates a decision by both patients and physicians about the relative benefit of chemotherapy and endocrine therapy."

Both tests offer an unambiguous result of "Low vs. High risk" for recurrence of a patient’s breast cancer, due to the larger panel of genes, according to Agendia.

The tests can be used for all age groups, and are not restricted by estrogen or HER 2 receptor status, helping physicians to provide better treatment.