Agendia announces that the 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.
- 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, USA and Amsterdam, the Netherlands, November 20, 2017 / B3C newswire / -- 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 Medicine(2) and the latest American Society for Clinical Oncology (ASCO) guideline update(3), 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.”
