Exceptional prognostic testing for breast cancer

The Prosigna® Breast Cancer Assay is a prognostic test that helps inform treatment decisions for patients with early-stage breast cancer.

Prosigna website
  • Screening
  • Diagnosis
  • Prognosis/​treatment selection
  • Recurrence monitoring

Prosigna

IMPROVING CARE FOR BREAST CANCER

The Prosigna test provides data for personalized treatment

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The Prosigna Breast Cancer Assay is a genomic test that is designed to help physicians and their breast cancer patients make more informed and confident treatment decisions. The test is indicated for post-menopausal patients with early-stage breast cancer that is hormone-receptor positive (HR+) and HER-2 receptor negative (HER2-). The Prosigna test uniquely assesses the activity of a 50-gene signature known as PAM50, which is based on the four key breast cancer molecular subtypes. It then combines this genomic analysis with clinical information to provide an accurate, reliable risk-of-recurrence (ROR) score and risk category. The ROR score indicates the potential that a patient’s cancer will recur within the next 10 years if they receive only anti-hormonal therapy.

The Prosigna test provides more comprehensive information than traditional testing approaches and has shown improved prognostic performance compared to older genomic tests.1 The Prosigna test is included in leading international clinical guidelines.2-7

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WHEN THE TEST IS USED

Assess recurrence risk after early-stage breast cancer diagnosis

The Prosigna test is used following breast cancer surgery to help physicians and their patients make decisions about chemotherapy. Patients with a high test score may need a more aggressive treatment plan that includes both hormone therapy and chemotherapy. Those with a lower score may receive hormone therapy alone, potentially avoiding chemotherapy and its side effects.

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LOW RISK

May potentially avoid treatment intensification (per guidelines)

INTERMEDIATE RISK

May need treatment intensification or further testing (per guidelines)

HIGH RISK

May need treatment intensification (per guidelines)

Clinical data for the Prosigna Breast Cancer Assay

The Prosigna test’s clinical validity and clinical utility have been demonstrated in studies involving more than 10,000 breast cancer patients.8 These include two prospective studies that validated the ability of the Prosigna test to provide accurate prognostic estimates in 2,500 breast cancer patients (total) with HR+ disease who were treated with five years of hormone therapy and followed for 10 years.9,10 Additionally, a subsequent analysis of over 2,500 Danish patients demonstrated this performance in a “real-world” population.11

>10K

patients were included in clinical validation and clinical utility studies for the Prosigna test.8

FEATURED PUBLICATIONS

In Journal of Clinical Oncology: “PAM50 Risk of Recurrence Score Predicts 10-Year Distant Recurrence in a Comprehensive Danish Cohort of Postmenopausal Women Allocated to 5 Years of Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer”

Journal of Clinical Oncology article

In JAMA Oncology: “Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor–Positive Breast Cancer”

JAMA Oncology article
All clinical data

Serving patients across the US and globally

The Prosigna test is offered as an in vitro diagnostic (IVD) test that laboratories perform on the nCounter® Analysis System. The test is FDA 510(k) cleared in the United States (US). It is also CE-IVD marked and available for use by clinicians in the European Union (EU) and other countries that recognize the CE mark. The test is widely reimbursed by government and other payers.

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A smiling physician shows medical information to a patient.
A woman receives a mammogram from a physician.

Learn about the Prosigna test for breast cancer

Prosigna website

REFERENCES

  1. Alexandre M. et al. Cancer Manag Res. 2019.

  2. Gradishar WJ, Moran MS, Abraham J, et al. NCCN Guidelines® Insights: Breast Cancer, Version 4.2023: Featured Updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2023;21(6):594-608. doi:10.6004/jnccn.2023.0031

  3. Andre F, et al. Journal of Clinical Oncology. 2022.

  4. Cardoso F, et al. Ann Oncol. 2019.

  5. Coates AS, et al. Ann Oncol. 2015

  6. Curigliano G, et al. Ann Oncol. 2017

  7. Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. National Institute for Health and Care Excellence. Accessed July 26, 2023. https://www.nice.org.uk/guidance/dg34

  8. Prosigna Breast Cancer Assay publications

  9. Dowsett M. et al. Journal of Clinical Oncology. 2013.

  10. Gnant M. et al. Annals of Oncology. 2014.

  11. Lænkholm A-V. et al. Journal of Clinical Oncology. 2018.

The Prosigna Breast Cancer Assay is FDA-cleared and CE-marked. For availability in individual EU countries and other territories outside of the US, please check with your local representative or distributor.

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