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What is the Prosigna test






Prosigna™ is a genetic test (CE / IVD - FDA), used to define a category of risk of recurrent metastatic disease in ten years in women undergoing surgery for breast cancer. The test investigates the expression profile of a group of 50 genes known as PAM50 and defines risk into three categories (low, intermediate, high) by assigning a score between 0 and 100. In this way, Prosigna™ offers useful evaluation criteria on whether to refer the patient to chemotherapy.


Advantages of the Test

The retrospective study NEMESI (Clavarezza M. et al., Biological characterization and selection criteria of adjuvant chemotherapy for early breast cancer: experience from the Italian NEMESI observational studies, BMC Cancer, 2012), conducted in 63 Italian centers, reported a rate prescription of adjuvant chemotherapy for breast cancer of 57.8%. The analysis of the results has allowed the authors to conclude that the chemotherapy treatment could have been avoided in a number of cases (approximately 25%).




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Independent International studies TransATAC and ABCSG-8 have confirmed, on sample size of 2,400 subjects, the test Prosigna™ provides additional information to the clinical/pathological variables (nodal status, tumor size and grade, age and type of treatment) and immunohistochemical factors (IHC4-ER, PGR, HER2 and Ki67). The results of the study TransATAC also found that the predictive ability of recurrence between 5 and 10 years after surgery with Prosigna™ is 15.1% higher when compared to the methods IHC4 and Oncotype DX®.











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