Prosigna Breast Cancer Assay Now Approved for Reimbursement in Germany

It's Time to Move Forward

 
 

Prosigna helps manage patients with early-stage breast cancer by providing an accurate assessment of recurrence risk

Managing patients with early-stage breast cancer begins with a highly accurate assessment of risk.

Proceed with Confidence

The Prosigna Breast Cancer Prognostic Gene Signature Assay uses advanced genomic technology to inform next steps for patients with early-stage breast cancer, based on the genomic make-up of their disease. The test analyzes the activity of 50 genes known as the PAM50 gene signature, along with clinical-pathological features, to provide a prognostic score indicating the probability of cancer recurrence during the next 10 years for hormone-receptor positive early breast cancer patients.

Prosigna is used to help guide therapeutic decisions so that patients receive therapeutic interventions, such as chemotherapy, only if clinically warranted. The in vitro diagnostic test is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:

  1.  A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors; or
  2.  A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐positive (1‐3 positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodes.

Prosigna uses the PAM50 gene signature to translate tumor biology into your patient’s individualized prognostic score.

Learn about PAM50

Advanced technology generates precise, reproducible prognostic information in local qualified laboratories.

How Prosigna works

Prosigna reliably identifies your patient’s 10-year risk of distant recurrence.

Clinical validation data

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.

Prosigna Breast Cancer Prognostic Gene Signature Assay for use on the nCounter® Dx Analysis System is 510(k) cleared and CE-marked for in vitro diagnostic use in the United States and EU, respectively. See Package Insert for details.