What is the POLARIS Nanostring Prosigna Breast Cancer Gene Signature Test
The Prosigna Breast Cancer Prognostic Gene Signature Assay is a FDA 510(k) and CE mark approved in vitro diagnostic assay performed on the NanoString nCounter Diagnostic Analysis System using RNA isolated from FFPE breast tumour tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data weighted together with clinical variables to generate a subtype (luminal A, luminal B, HER2-enriched or basal-like), and a score indicative of the probability of distant recurrence of disease in a 10 year timeframe
How will the Nanostring Prosigna Test results affect treatment for breast cancer patients?
This test is intended for use by a physician to obtain a prognosis in patients with previously diagnosed invasive breast carcinoma. Any drugs selected based on potential (or lack of) clinical benefit for the treatment of a patient's disease are the responsibility of the physician. All relevant clinical patient information must be considered in combination with information in this report before the physician decides on an appropriate course of treatment.
How are patients assured of the quality for the Nanostring Prosigna Test?
The Nanostring Prosigna Test is an FDA, unmodified 510(k) and CE mark approved in vitro diagnostic test. The Nanostring Prosigna is verified according to CAP guidelines for FDA, unmodified tests, and a clinical report is provided indicating intrinsic subtype and a score to indicate probability of distant recurrence for breast cancer patients.
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