Resources*
Prosigna Package Insert
To download the Prosigna Package Insert, select a language from the options below:
nCounter® Dx Analysis System User Manual
To download the nCounter Dx Analysis System User Manual, select a language from the options below:
Roche FFPET Kit Package Insert
1. Go to https://dialog1.roche.com/PI/us/eLabDoc
2. Enter REF number printed on the outside of the Roche kit box
3. Choose the newest version of Method Sheet and download
Prosigna Patient Report
Click the image for an overview of the Patient Report. A sample patient report will soon be available to download.
List of publications
Intrinsic subtypes
Perou CM, Sørlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature. 2000;406(6797):747-752. See article
Sørlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001;98(19):10869-10874. See article
Sørlie T, Tibshirani R, Parker J, et al. Repeated observation of breast tumor subtypes in independent gene expression data sets. Proc Natl Acad Sci U S A. 2003;100(14):8418-8423. See article
Fan C, Oh DS, Wessels L, et al. Concordance among gene-expression-based predictors for breast cancer. N Engl J Med. 2006;355(6):560-569. See article
PAM50
Parker JS, Mullins M, Cheang MC, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol. 2009;27(8):1160-1167. See article
Nielsen TO, Parker JS, Leung S, et al. A comparison of PAM50 intrinsic subtyping with immunohistochemistry and clinical prognostic factors in tamoxifen-treated estrogen receptor-positive breast cancer. Clin Cancer Res. 2010;16(21):5222-5232. See article
Chia SK, Bramwell VH, Tu D, et al. A 50-gene intrinsic subtype classifier for prognosis and prediction of benefit from adjuvant tamoxifen. Clin Cancer Res. 2012;18(16):4465-4472. See article
Cheang MC, Voduc KD, Tu D, et al. Responsiveness of intrinsic subtypes to adjuvant anthracycline substitution in the NCIC.CTG MA.5 randomized trial. Clin Cancer Res. 2012;18(8):2402-2412. See article
Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70. See article
Prosigna
Dowsett M, Sestak I 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 Aug 1;31(22):2783-90. See article
Sestak I, Dowsett M et al. Factors predicting late recurrence for estrogen receptor-positive breast cancer. J Natl Cancer Inst. 2013 Oct 2;105(19):1504-11. See article
Jørgensen CL, Nielsen TO et al. PAM50 breast cancer intrinsic subtypes and effect of gemcitabine in advanced breast cancer patients. Acta Oncol. 2014 Jun;53(6):776-87. See article
Gnant M, Filipits M et al. on behalf of Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014 Feb;25(2):339-45. See article
Filipits M, Nielsen TO et al. The PAM50 risk-of-recurrence score predicts risk for late distant recurrence after endocrine therapy in postmenopausal women with endocrine-responsive early breast cancer. Clin Cancer Res. 2014 Mar 1;20(5):1298-305. See article
Nielsen T, Wallden B et al. Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens. BMC Cancer. 2014 Mar 13;14:177. See article
Ralph Boccia: Translating Research into Practice: the Prosigna (PAM50) Gene Signature Assay. See article
David Dabbs: A Comparison of Breast Cancer Multianalyte Assays with Algorithmic Analyses (MAAA) for their Net Predictive/Prognostic Value. See article
Francisco Esteva: Genomic Signatures in Breast Cancer: Limitations of Available 0Predictive Data and the Importance of Prognosis. See article
Martin M, Gonzalez-Rivera M, Morales S, Haba-Rodriguez J, Gonzalez-Cortijo L, Manso L et al. Prospective study of the impact of the Prosigna assay on adjuvant clinical decision-making in unselected patients with estrogen receptor-positive, HER2-negative, node-negative early-stage breast cancer. Curr Med Res Opin. 2015:1-28.” See article
Prat A, Galvan P, Jimenez B, Buckingham W, Jeiranian HA, Schaper C et al. Prediction of Response to Neoadjuvant Chemotherapy Using Core Needle Biopsy Samples with the Prosigna Assay. Clin Cancer Res. 2015.Harbeck et al.” See article
Gnant M, Sestak I, Filipits M, Dowsett M, Balic M, Lopez-Knowles E et al. Identifying Clinically Relevant Prognostic Subgroups of Postmenopausal Women with Node-positive Hormone Receptor Positive Early Stage Breast Cancer Treated with Endocrine Therapy: A combined analysis of ABCSG-8 and ATAC using the PAM50 risk of recurrence score and Intrinsic Subtype. 2015 Aug;26(8):1685-91.” See article
Wallden et al. Development and Verification of the PAM50-based Prosigna Breast Cancer Gene Signature Assay. BMC Med Genomics. 2015;8:54.” See article
Ligibel JA, Cirrincione CT et al. Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance). J Natl Cancer Inst. 2015 Jun 25;107(9). See article
Liu S, Chapman JA et al. Prognostic and predictive investigation of PAM50 intrinsic subtypes in the NCIC CTG MA.21 phase III chemotherapy trial. Breast Cancer Res Treat. 2015 Jan;149(2):439-48. See article
Sestak I, Cuzick J et al. Prediction of late distant recurrence after 5 years of endocrine treatment: a combined analysis of patients from the Austrian breast and colorectal cancer study group 8 and arimidex, tamoxifen alone or in combination randomized trials using the PAM50 risk of recurrence score. J Clin Oncol. 2015 Mar 10;33(8):916-22.). See article
Dowsett M, Sestak I, Lopez-Knowles E, 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):2783-2790. See article
Gnant M, Filipits M, Mlineritsch B, et al; Austrian Breast and Colorectal Cancer Study Group. Clinical validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of distant-recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC): an ABCSG study. Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX. Abstract P2-10-02. See article
Gnant M, Filipits M, Dubsky P, et al. Predicting risk for late metastasis: the PAM50 risk of recurrence (ROR) score after 5 years of endocrine therapy in postmenopausal women with HR+ early breast cancer: a study on 1,478 patients from the ABCSG-8 trial. Presented at: European Society for Medical Oncology IMPAKT 2013 Breast Cancer Conference; May 2-4, 2013; Brussels, Belgium. Abstract 53O_PR. See article
Sestak I, Dowsett M, Sgroi D, et al. Comparison of five different scores for the prediction of late recurrence for oestrogen receptor-positive breast cancer. Presented at: European Society for Medical Oncology IMPAKT 2013 Breast Cancer Conference; May 2-4, 2013; Brussels, Belgium. Abstract 540_PR. See article
Sestak I, Dowsett M, Zabaglo L, et al. Factors predicting late recurrence for estrogen receptor–positive breast cancer. J Natl Cancer Inst. 2013;105(19):1504-1511. See article
Nielsen T, Wallden B, Schaper C, et al. Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens [published online ahead of print March 13, 2014]. BMC Cancer. doi:10.1186/1471-2407-14-177. See article
Gnant M, Dowsett M, Filipits M, et al. Identifying clinically relevant prognostic subgroups in node-positive postmenopausal HR+ early breast cancer patients treated with endocrine therapy: a combined analysis of 2,485 patients from ABCSG-8 and ATAC using the PAM50 risk of recurrence (ROR) score and intrinsic subtype. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL. Abstract 506. See article
Gnant M, Filipits M, Greil R, et al; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014;25(2):339-345. See article
Filipits M, Nielsen TO, Rudas M, et al; Austrian Breast and Colorectal Cancer Study Group. The PAM50 risk-of-recurrence score predicts risk for late distant recurrence after endocrine therapy in postmenopausal women with endocrine-responsive early breast cancer [published online ahead of print February 11, 2014]. Clin Cancer Res. 2014;20(5):1298-1305. doi:10.1158/1078-0432.CCR-13-1845. See article
Sestak I, Cuzick J, Dowsett M, et al; Prediction of Late Distant Recurrence After 5 Years of Endocrine Treatment: A Combined Analysis of Patients From the Austrian Breast and Colorectal Cancer Study Group 8 and Arimidex, Tamoxifen Alone or in Combination Randomized Trials Using the PAM50 Risk of Recurrence Score. J Clin Oncol. 2014 Oct 20. pii: JCO.2014.55.6894. See article
Verification study
TransATAC clinical verification study
Click here to access the TransATAC clinical verification study article, available through Journal of Clinical Oncology.
Clinical validation
ABCSG-8 clinical validation study
Click here to access the ABCSG-8 clinical validation study article.
Analytical validation
Click here to access the analytical validation study, available through BMC Cancer.
*Veracyte has acquired the Prosigna test. Materials are in transition
