MammaPrint® is the first and only multigene test to receive level 1A status, based on prospective, randomized data from the MINDACT trial
IRVINE, CA and AMSTERDAM, 21 March 2017 – Agendia, a world leader in personalized medicine and molecular cancer diagnostics, announces that updated guidelines from the European Group on Tumour Markers (EGTM), published recently online in the European Journal of Cancer (EJC), name the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence test as the first and currently the only multigene test of its kind deemed to have level 1A evidence for its clinical use.1
The EGTM is a group of European-based cancer thought leaders encompassing clinical biochemists, pathologists, physicians, surgeons and scientists from the diagnostics industry with an interest in tumour markers. Multigene tests, such as MammaPrint, play an essential role in the management of patients with breast cancer. The EGTM comprehensively examined the validation of these tests in prospective or prospective-retrospective trials, systematic reviews, pooled/meta-analyses of biomarker studies and relevant guidelines published by other expert panels in making their recommendations.
Based on this review, MammaPrint is the first and currently the only multigene test to receive the highest level of evidence of 1A, following the publication of the prospective, controlled and randomized Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) trial results on 25 August 2016, in the prestigious New England Journal of Medicine (NEJM).2 Importantly, the criteria for level 1A evidence requires the publication of the full results of a trial and that the primary endpoint is met.1
Referencing MINDACT, the guidelines state that “the results of this randomized prospective trial clearly showed that the use of MammaPrint test can alter the clinical practice by decreasing the frequency of administrating adjuvant chemotherapy to patients deemed to be at high risk based on traditional clinical and pathological factors, without impairing the long-term outcome.”1
The EGTM recognized other multigene tests such as Oncotype DX, Prosigna, and EndoPredict with level 1B evidence as they do not currently have published outcomes data of a prospective trial that randomized patients to chemotherapy vs no chemotherapy and met its primary objective.
Dr. William Audeh, Chief Medical Officer at Agendia said: “It is great to see these specialized guidelines recommending MammaPrint to healthcare professionals and their patients. It is also very encouraging to note that the decision to recognize MammaPrint with the highest level of clinical evidence was reached following a thorough review and consideration of the prospective, randomized data that underpins it. Guidelines have the potential to impact the treatment of thousands of patients globally and we are committed to ensuring that many more women can benefit from the risk-of-recurrence results provided by MammaPrint to enable more tailored, individualized breast cancer management.”
MammaPrint has been recently recognized as being supported by level 1A clinical evidence by the German Gynecological Oncology Group (AGO) in Germany and is also recommended for use in other important best-practice European Society for Medical Oncology (ESMO) and the St. Gallen Consensus Guidelines.
The newly-revised 2017 U.S. National Comprehensive Cancer Network® (NCCN®) Breast Cancer Treatment Guidelines3 note the initial results of the MINDACT trial, which were presented at the American Association of Cancer Research (AACR) Annual Meeting in April 2016.4 However they do not consider the full results of the trial, as published in the NEJM, due to this taking place in August, after the NCCN’s submission deadline for consideration in the 2017 guidelines, which was 1 July 2016.
Prognostic tests are currently included in the NCCN guidelines in the treatment pathway of early-stage ER+, HER2-, LN- breast cancer. Agendia believes that when the final results of the MINDACT trial are taken into account the NCCN, like the EGTM and AGO, will recognize the highest level of evidence provided by this data.
3 National Comprehensive Cancer Network. Breast Cancer (Version 1.2017). Pages MS-2, MS-30. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf Accessed 10 March 2017.
4 Piccart M, Rutgers E, van’ t Veer L, et al. Primary analysis of the EORTC 10041/BIG 3-04 MINDACT study: a prospective, randomized study evaluating the clinical utility of the 70-gene signature (MammaPrint) combined with common clinical-pathological criteria for selection of patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 16-20 April 2016; New Orleans, Louisiana: AACR; 2016. Abstract CT039 2016.
MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis within 5 years. MammaPrint also carries the CE Mark which certifies that the test complies with the quality standards set by the European In Vitro Diagnostic Directive, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.
The early findings of the Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) trial were presented in April 2016 at the American Association for Cancer Research (AACR) Annual Meeting. The full results were later published in August 2016 in the prestigious New England Journal of Medicine (NEJM). The main finding, in reference to Agendia’s MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence test, is that the use of MammaPrint in all clinically high-risk patients would result in a 46% reduction in the administration of chemotherapy.
Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include MammaPrint®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information, visit www.agendia.com.
Daniel Gooch / Léon Melens / Samantha Schmidt
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