Prosigna (PAM50)
A 50-gene test run in local hospital laboratories that estimates the ten-year risk of a hormone-positive breast cancer coming back.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2013 | Prognosis of distant recurrence in postmenopausal HR+ early breast cancer (510(k)) |
| EU | 2012 | CE-IVD |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: a low ROR score means chemotherapy is unlikely to help on top of hormone therapy; a high score means it is likely to be recommended.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductBreast Cancer Index
Shares EndoPredict, Oncotype DX, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer and the tag test.
- ProductAfirma Genomic Sequencing Classifier
Shares Veracyte (Decipher), RNA sequencing & expression profiling and the tag test.
- ProductMI Cancer Seek
Shares RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer and the tag test.
- ProductCxbladder
Shares RNA sequencing & expression profiling and the tag test.
- ProductLunit INSIGHT MMG
Shares HR-positive / HER2-negative breast cancer and the tag test.
- ProductOncotype DX Genomic Prostate Score
Shares RNA sequencing & expression profiling and the tag test.
- ProductProFound AI (iCAD)
Shares HR-positive / HER2-negative breast cancer and the tag test.
- ProductProlaris
Shares RNA sequencing & expression profiling and the tag test.