Prosigna
 

What is Prosigna?

The Prosigna Breast Cancer Prognostic Gene Signature Assay is a qualitative in vitro diagnostic tool that utilizes multi-parameter gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a
patient’s risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. 

• Prosigna is the only PAM50-based, early-stage breast cancer assay to deliver a highly accurate assessment of risk of distant recurrence with a personalized prognostic score that identifies your patient’s 10-year risk.
   
• Prosigna together with the nCounter® Dx Analysis System delivers genomic testing results with meaningful decreased turnaround times from local qualified laboratories.
   
• Prosigna accurately classifies breast cancer into one of the 4 intrinsic subtypes: Luminal A, Luminal B, HER-2 enriched, or Basal-like. Correct knowledge of the biological classification of the tumour type allows better prediction of how the disease will behave.
   

What is PAM50?

•  A gene classifier algorithm that uses a 50-gene expression profile to assign breast cancer to one of four PAM50 molecular subtypes determined by the tumour’s molecular profile.
   
• Gene expression data are weighted with clinical variables to determine the Prosigna score, an integer score from 0-100 indicative of the probability of distant recurrence.
   
• Prosigna Score is based on tumour size, proliferation score, and the gene expression profile of PAM50 molecular subtypes.

Why choose Prosigna?

Prosigna provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years, helping to inform clinical decisions with prognostic information beyond standard clinical variables (age, grade, tumour size, nodal status, and adjuvant therapy).

• Validated on 2,479 samples in the combined ABCSG-8 and TransATAC studies.
   
• CE-marked for FFPE breast tumour tissue on the nCounter® Dx Analysis System.
   
• Recognized and listed in multiple international guidelines including ASCO, NCCN, and ESMO.
   
• Positive opinions of prognostic ability during St Gallen consensus vote:
   

  • 80% of experts agree that Prosigna risk assessment is valuable during years 1-5 in pN0 ER+ HER2- disease.

  • 75% agree that Prosigna risk assessment is valuable during years 1-5 for pN+ (i.e. in 1-3 involved lymph nodes).

  • 63% agree that Prosigna risk assessment is valuable beyond 5 years.

Which patients are appropriate for Prosigna? 

Postmenopausal women with hormone receptor-positive, node-negative (Stage I or Stage II), or node-positive (Stage II and IIIA) breast cancer to be treated with adjuvant endocrine therapy.