MammaPrint® is a targeted RNA sequencing, NGS-based diagnostic test with level 1 clinical evidence that provides testing of early-stage breast cancer, indicates the prognostic profile for the risk assessment of recurrence of breast cancer, and assists in postoperative chemotherapy decision-making.
We entered into a partnership with Agendia N.V. and Agendia, Inc. (Agendia N.V. together with Agendia, Inc., “Agendia”) with respect to the exclusive rights to commercialize MammaPrint® in China.
According to Frost & Sullivan, MammaPrint® is the first NGS-based breast cancer recurrence assay to be offered in China.
MammaPrint® detects 70 genes of seven critical genomic pathways associated with breast cancer metastasis, from tumor growth and proliferation through adaptation to a microenvironment at a secondary site, from FFPE tissue samples.
The detection of the gene expression profile from the FFPE tissue samples provided by patients with breast cancer provides patients a prognosis and recurrence risk assessment.
MammaPrint®’s clinical validity and utility are supported by over 20 years of clinical validation, 200 research collaborations and hundreds of publications.
MammaPrint® is recommended under NCCN guidelines for breast cancer as a multigene assay for consideration of addition of adjuvant system chemotherapy to adjuvant endocrine therapy.
In addition, MammaPrint® has been approved by multiple international clinical guidelines and endorsed by industry experts, including the German Gynecological Oncology Group (the “AGO”), the American Joint Committee on Cancer (the “AJCC”), the ASCO, the European Group on Tumour Markers (“EGTM”), the European Society for Medical Oncology (the “ESMO”), the National Borstkanker Overleg Nederland (“NABON”), the NCCN and St. Gallen International Breast Cancer Consensus.
MammaPrint® obtained CE marking in March 2018 and the microarray-based version of MammaPrint® had obtained 510(k) clearance from the FDA in June 2007.