- Update clarifies that the patient and clinician may choose any genomic profile or multigene panel based on available clinical evidence at the time of treatment
- In line with recent publications from NEJM and ASCO, the AJCC now recognizes MammaPrint with Level I evidence for determining clinical prognosis, which is the basis for chemotherapy treatment decisions
IRVINE, CA, AMSTERDAM, NETHERLANDS – 20 November 2017 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces that the American Joint Committee on Cancer (AJCC) has recently issued a Breast Cancer Update and Correction which revised and clarified the Cancer Staging Manual, 8th Edition regarding the use of multigene genomic profiles for Pathological Prognostic Staging.1
The Expert Panel update clearly states that obtaining a genomic profile is not required for assigning Pathological Prognostic Stage. Additionally, they do not endorse the use of any specific multigene genomic panel. These statements clarify that the use of MammaPrint is compliant with Commission on Cancer – National Accreditation Program for Breast Centers (CoC-NAPBC) accreditation standards.
One implication of this update is that, unlike for MammaPrint, the use of one multigene panel (21-gene assay) will require specific monitoring by breast centers for down-staging a limited and infrequent number of patients. This may require breast centers to implement costly and complex systems.
Furthermore, as with a recent publication in the New England Journal of Medicine2 and the latest American Society for Clinical Oncology (ASCO) guideline update3, the AJCC Task Panel recognizes that MammaPrint has Level 1 evidence, based on MINDACT, for determining clinical prognosis.
MammaPrint is currently the only breast cancer risk of recurrence test that is recognized by ASCO and AJCC for use in clinically high risk patients.
Dr. William Audeh, Chief Medical Officer at Agendia, said:
“Agendia is pleased to see AJCC has clarified that genomic profiling is not necessary for staging, and that the main reason for ordering these tests is to provide clinically relevant information which helps physicians make adjuvant therapy decisions. The recent ASCO Breast Cancer Guideline and now this AJCC update confirm the Level 1 clinical utility evidence for MammaPrint from the MINDACT trial.”
1 American Joint Committee on Cancer. M.B.Amin et al. (eds.) AJCC Cancer Staging Manual, 8th Edition-Breast Chapter Update. Nov 10, 2017
2 Cardoso F., et al. N Engl J Med. 2016 Aug 25;375(8):717-29. DOI: 10.1056/NEJMoa1602253.
3 Krop I., et al. Journal of Clinical Oncology 35, no. 24 (August 2017) 2838-2847. DOI: 10.1200/JCO.2017.74.0472.
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MammaPrint is an 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. MammaPrint is cleared by the US FDA and carries the CE Mark, , 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.
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 the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test that provide 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 on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.
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Instinctif Partners (Agendia)
Ashley Tapp / Lynne Trowbridge / Samantha Cheung
Tel: +44 (0) 20 7866 7923