Prosigna is an assay based on the PAM50 gene expression signature and has recently been shown to predict the risk of distant recurrence in women with hormone receptor positive in early stage breast cancer treated with five years of endocrine therapy
The assay measures the profile of gene expression using RNA extracted from formalin-fixed paraffin-embedded (FFPE) breast tumours.
The data of the expression of 50 genes are weighted together with clinical variables in order to produce a sub-type (luminal A, luminal B, HER2-enriched and basel –like) and a score the probability of distant recurrence of the disease.
The test is indicated as prognostic indicator for distant recurrence-free survival at 10 yrs in postmenopausal women with hormone receptor positive (HR+) and stage I (lymph node negative) or II (1-3 lymph nodes positive) breast cancer who have undergone surgery and loco-regional treatment procedure as a standard of care. The device is not intended for patients with four or more positive nodes.
The test is performed on NanoString Right nCounter® in 7 working days after the reception of sample.
Prosigna is now included in International clinical practice guidelines