Prosigna: A New Way of Looking at Breast Cancer
Based on the PAM50 gene signature, Prosigna uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna assay:
- Is FDA 510(k) cleared for node-negative (stage I or II) or node-positive (stage II), hormone receptor-positive (HR+) breast cancer patients
- Provides fast and accurate individualized assessment of a patient’s risk of recurrence at 10 years if given endocrine therapy alone
- Utilizes proven clinical and analytical capabilities
- Offers improved prognostic value over other breast cancer tests on the market
“This is the next generation of diagnostics, which embraces both the molecular and anatomic features of a tumor to provide a more accurate estimate of risk,” said Philip Bernard, MD, ARUP Laboratories' medical director and associate professor in the Department of Pathology at the University of Utah.
Prosigna and ARUP
ARUP is a licensed provider of the Prosigna assay. The University of Utah and the Huntsman Cancer Institute in Salt Lake City were integral in developing the 50-gene expression signature for prognosis and prediction to therapies. Dr. Philip Bernard, a co-inventor of the test and medical director of molecular oncology diagnostics at ARUP Laboratories, oversees the test and can provide additional consultation through ARUP Client Services.
- NanoString Prosigna website
- Additional Technical Information
for Prosigna. Requires Adobe Acrobat Reader to view.
- Press release: NCCN Clinical Practice Guidelines for Breast Cancer Acknowledge Prosigna/PAM50 as Clinically Validated for Prediction of Prognosis
- Press release: ARUP Laboratories Adds Prosigna to Its Test Menu
- Press release: Huntsman Cancer Institute Discovery Translates into Clinical, FDA-Cleared Breast Cancer Test at ARUP Laboratories
- Press release: NanoString Technologies Announces Adoption of the Prosigna Breast Cancer Assay by Leading US Clinical Laboratories and Cancer Centers
- The Scientist: Top 10 Innovations 2013
- Dowsett M, et al. Comparison of PAM50 risk of recurrence score with Oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy. J Clin Oncol 2013; 31(22):2783–90.