The First with FDA IVDMIA Clearance

MammaPrint is the first and only in vitro diagnostic multivariate index assay (IVDMIA) to be cleared by the FDA for breast cancer recurrence. Prior to its clearance, the FDA reviewed evidence that the test had been properly validated for its use.⁽¹⁾

When MammaPrint was cleared in February of 2007, The Director of the Office of In Vitro Diagnostic Evaluation stated, “There have been rapid advances in microarrays and other pioneering diagnostics, and a corresponding increase in the use and impact of these complex devices. This has prompted FDA to take a closer look at the potential risks as well as the benefits associated with such tests when they are developed and used in laboratories. This test clearance takes into account the development of these innovative technologies and ensures public health by carefully evaluating their performance.” 

An IVDMIA is a device that combines the values of multiple variables using an interpretative function (bioinformatics algorithm) to provide a single, patient specific result, that is intended for use in the diagnosis of disease and which provides a result whose derivation is non-transparent and for that reason cannot be independently derived or verified by the end user.  MammaPrint is the only gene expression breast cancer test currently available in the United States that has met the FDA's strict IVDMIA criteria.

MammaPrint's FDA clearance confers confidence in its safety and effectiveness, ensuring that the peer reviewed, published studies used in its development, validation and IVDMIA clearance have been evaluated by the United States Food and Drug Administration.  The FDA label indicates that as a diagnostic tool, MammaPrint has a 98.9% degree of accuracy in classifying patients as Low Risk or High Risk and technical reproducibility of 98.5%. 

It is significant, based upon these stringent requirements, that MammaPrint remains today the only FDA-cleared IVDMIA test for Breast Cancer.