A product of Agendia BV, MammaPrint® breast cancer diagnostic test is a gene expression profiling service to assess the risk of recurrence in breast cancer patients recently cleared by the USFDA.
A U.S. Regulatory milestone as the first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire market clearance from the FDA.
According to Dr. Bernhard Sixt, Chief Executive Officer at Agendia:
“As the first test of its kind cleared by the FDA, this type of regulatory review benefits breast cancer patients and provides regulatory clarity to the medical community.
At present, MammaPrint® is the first cleared IVDMIA which can be marketed in the …read more