8 February 2007
The Food and Drug Administration (FDA) has approved the Agendia MammaPrint® test for marketing within the US (see press release). MammaPrint® is a microarray-based prognostic test that analyses expression of a set of seventy key genes in breast tumour cells to predict the risk of metastasis. Developed by Netherlands-based company Agendia, the test has been available since 2005, and guides therapy by indicating which lymph node-negative breast cancer patients are likely to require chemotherapy in addition to surgical intervention.
The test is the first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to receive market clearance from the FDA under new guidance developed for the regulation of complex molecular tests that assess the expression of multiple genes (see previous news story). Previously, tests developed and administered by single companies have been exempt from normal FDA regulation, but it was considered that tests based on more complex systems such as microarray analysis required scrutiny to ensure maximum safety and efficacy, and that tests can be clearly interpreted by clinicians.