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A 50-gene test run in local hospital laboratories that estimates the ten-year risk of a hormone-positive breast cancer coming back.
Prosigna was cleared by the FDA on 6 September 2013 (510(k) K130010, NanoString; now marketed by Veracyte) for postmenopausal women with hormone-receptor-positive, node-negative or one-to-three-node-positive early breast cancer treated with endocrine therapy. Validation came from the ABCSG-8 and TransATAC cohorts, where the ROR score predicted distant recurrence at 10 years, including late recurrence after five years. NICE diagnostics guidance DG34 (2018) recommends Prosigna, Oncotype DX and EndoPredict for guiding adjuvant chemotherapy decisions in the NHS. Because it runs on a decentralised instrument, it is common in Europe where send-out testing is less used.
nCounter digital expression of 50 classifier genes assigns an intrinsic subtype (luminal A, luminal B, HER2-enriched, basal-like) and a risk-of-recurrence (ROR) score combined with tumour size and nodal status.
1.Prosigna (PAM50) slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2013 | Prognosis of distant recurrence in postmenopausal HR+ early breast cancer (510(k)) |
| EU | 2012 | CE-IVD |
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Query for this drug: (TITLE:"Prosigna" OR ABSTRACT:"Prosigna" OR TITLE:"PAM50" OR ABSTRACT:"PAM50") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Prosigna (PAM50), not a curated reading list.
Shares EndoPredict, Oncotype DX, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer and the tag test.
Shares Veracyte (Decipher), RNA sequencing & expression profiling and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, HR-positive / HER2-negative breast cancer and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, HR-positive / HER2-negative breast cancer and the tag test.
Shares RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment and the tag test.
Shares RNA sequencing & expression profiling and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment and the tag test.