MammaPrint is the first "in vitro diagnostic multivariate index assay"
test (IVDMIA) cleared by the U.S. Food and Drug Administration (FDA).
FDA clearance requires clinical and analytical validation and reporting
systems to ensure patient safety issues are addressed. Highly accurate,
MammaPrint identifies patients with early metastasis and patients who
are likely to develop metastases within five years following surgery.
“We
are excited to be a part of Agendia’s continued growth and to enable
the company to bolster its strategic marketing and sales efforts as it
brings MammaPrint to an ever increasing number of breast cancer
patients,” says Gertjan van der Baan, Board Member on behalf of van
Herk Group, Agendia’s largest investor.