Global InformationMammaPrint information
MammaPrint is a prognostic and predictive diagnostic test for early stage breast cancer patients that assess the risk that a tumor will metastasize to other parts of the body.[1] It gives a binary result, high-risk or low-risk classification, and helps physicians determine whether or not a patient will benefit from chemotherapy. Women with a low risk result can safely forego chemotherapy without decreasing likelihood of disease free survival.[2] MammaPrint is part of the personalized medicine portfolio marketed by Agendia.
MammaPrint is based on the Amsterdam 70-gene breast cancer gene signature and uses formalin-fixed-paraffin-embedded (FFPE) or fresh tissue for microarray analysis.[3] It is a laboratory developed test (LDT) which falls into the class of In Vitro Diagnostic Multivariate Index Assays (IVDMIA). MammaPrint was the first (2007) IVDMIA to be cleared by the Food and Drug Administration (FDA) in a De Novo Classification Process (Evaluation of Automatic Class III Designation) and is the only molecular diagnostic test with a randomized prospective clinical trial validating clinical utility.[4] The test uses RNA isolated from tumor samples and run on custom glass microarray slides in order to determine the expression of a 70-gene signature. The expression profile is then used in a proprietary algorithm to categorically classify the patient as being at either high or low risk of breast cancer recurrence.
MammaPrint has been prospectively, clinically validated for use in early stage (I and II) breast cancer patients regardless of estrogen receptor (ER) or Human Epidermal Growth Factor Receptor 2 (HER2) status, with a tumor size ≤ 5.0 cm, and 0-3 positive lymph nodes (LN0-1), with no special specifications for N1mi pathology.[5][6] This differentiates MammaPrint from other multi-gene assays in use today that have only shown predictive value in ER positive, HER2 negative, lymph node (LN) negative patients. MammaPrint is also indicated for patients with ER negative tumors (15% of tumors[7]). There are no exclusion criteria based on histopathologic tumor type (i.e. ductal, lobular, mixed, etc.) or age. MammaPrint is predictive for pre- and post-menopausal women.[8][9]
- ^ "Agendia | Agendia". www.agendia.com. Retrieved 2017-03-27.
- ^ Cardoso, Fatima; van’t Veer, Laura J.; Bogaerts, Jan; Slaets, Leen; Viale, Giuseppe; Delaloge, Suzette; Pierga, Jean-Yves; Brain, Etienne; Causeret, Sylvain (2016-08-25). "70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer" (PDF). New England Journal of Medicine. 375 (8): 717–729. doi:10.1056/NEJMoa1602253. hdl:10044/1/39633. ISSN 0028-4793. PMID 27557300.
- ^ van 't Veer LJ, Dai H, van de Vijver MJ, et al. (2002). "Gene expression profiling predicts clinical outcome of breast cancer". Nature. 415 (6871): 530–6. doi:10.1038/415530a. hdl:1874/15552. PMID 11823860. S2CID 4369266.
- ^ Simon, Richard M.; Paik, Soonmyung; Hayes, Daniel F. (2009-11-04). "Use of archived specimens in evaluation of prognostic and predictive biomarkers". Journal of the National Cancer Institute. 101 (21): 1446–1452. doi:10.1093/jnci/djp335. ISSN 1460-2105. PMC 2782246. PMID 19815849.
- ^ Cardoso, Fatima; van’t Veer, Laura J.; Bogaerts, Jan; Slaets, Leen; Viale, Giuseppe; Delaloge, Suzette; Pierga, Jean-Yves; Brain, Etienne; Causeret, Sylvain (2016-08-25). "70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer" (PDF). New England Journal of Medicine. 375 (8): 717–729. doi:10.1056/NEJMoa1602253. hdl:10044/1/39633. ISSN 0028-4793. PMID 27557300.
- ^ Drukker, C. A.; Bueno-de-Mesquita, J. M.; Retèl, V. P.; van Harten, W. H.; van Tinteren, H.; Wesseling, J.; Roumen, R. M. H.; Knauer, M.; van 't Veer, L. J. (2013-08-15). "A prospective evaluation of a breast cancer prognosis signature in the observational RASTER study". International Journal of Cancer. 133 (4): 929–936. doi:10.1002/ijc.28082. ISSN 1097-0215. PMC 3734625. PMID 23371464.
- ^ "Hormone Therapy for Breast Cancer". www.cancer.org. Retrieved 2017-03-27.
- ^ Mook, S.; Schmidt, M. K.; Weigelt, B.; Kreike, B.; Eekhout, I.; van de Vijver, M. J.; Glas, A. M.; Floore, A.; Rutgers, E. J. T. (2010-04-01). "The 70-gene prognosis signature predicts early metastasis in breast cancer patients between 55 and 70 years of age". Annals of Oncology. 21 (4): 717–722. doi:10.1093/annonc/mdp388. ISSN 1569-8041. PMID 19825882.
- ^ Wittner, Ben S.; Sgroi, Dennis C.; Ryan, Paula D.; Bruinsma, Tako J.; Glas, Annuska M.; Male, Anitha; Dahiya, Sonika; Habin, Karleen; Bernards, Rene (2008-05-15). "Analysis of the MammaPrint breast cancer assay in a predominantly postmenopausal cohort". Clinical Cancer Research. 14 (10): 2988–2993. doi:10.1158/1078-0432.CCR-07-4723. ISSN 1078-0432. PMC 3089800. PMID 18483364.