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 US in compliance with these new FDA guidelines. We are exploring ways to make this product available in the US.”

Read the full press release.

Post from: Blisstree

MammaPrint®: First In Vitro Diagnostic Multivariate Index Assay (IVDMIA) Cleared by the USFDA