Prosigna Breast Cancer Assay Now Approved for Reimbursement in Germany

Prosigna Algorithm

 
 

The technology behind the Prosigna test

Every Prosigna Score is generated by a proprietary algorithm1

  • The Prosigna Score is a numerical value on a 0-100 scale that correlates with the probability of distant recurrence within 10 years.
  • The gene expression profile of a patient’s tumor is compared with each of the 4 PAM50 prototypical molecular profiles to determine the degree of similarity. The results in combination with a proliferation score and tumor size produce an individualized Prosigna Score.

*Prosigna Score is Prosigna’s proprietary model for predicting risk of recurrence in a patient.

References:
1.
Prosigna [Package Insert]. Seattle, WA: NanoString Technologies, Inc; 2013.
2. Nielsen T, McDonald S, Kulkarni S, et al. Analytical reproducibility of the breast cancer intrinsic subtyping test and nCounter® Analysis System using formalin-fixed paraffin-embedded (FFPE) breast tumor specimens. Poster presented at: 102nd United States and Canadian Academy of Pathology Annual Meeting; March 2-8, 2013; Baltimore, MD. Abstract 2075.
3. Gnant M, Filipits M, Mlineritsch B, et al; Austrian Breast and Colorectal Cancer Study Group. Clinical validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of distant-recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC): an ABCSG study. Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX. Abstract P2-10-02

Prosigna is indicated for in vitro diagnostic use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II), or node-positive (Stage II) breast cancer to be treated with adjuvant endocrine therapy for assessment of risk of distant recurrence of disease.