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FDA Clears Agendia's MammaPrint Dx; First IVDMIA to Get Green Light

NEW YORK (GenomeWeb News) — The US Food and Drug Administration yesterday said it has cleared Agendia’s MammaPrint diagnostic for breast cancer recurrence.
The test is the first in vitro diagnostic multivariate index assay device approved by the agency since it released a draft guidance describing such products last year.
As GenomeWeb News reported last fall, IVDMIAs use mathematical formulas to interpret gene and protein data to guide medical decision-making, according to the draft guidance, which can be read here.
Agendia developed the test from a set of 70 genes and a specific algorithm to diagnose the likelihood that a tumor will reoccur.
Physicians may use the test to calculate follow-up therapy for breast cancer patients, the FDA said.
The agency said Agendia had submitted data from tumor sample studies from 302 European patients as evidence that the test was “validated for its intended use.”
The FDA said these data “sufficiently confirmed that Agendia’s test could be used to predict “time to distant metastasis” in women aged 61 years and younger, in some women with early stage breast cancer, and in some women with tumors less then five centimeters.

"There have been rapid advances in microarrays and other pioneering diagnostics, and a corresponding increase in the use and impact of these complex tests,” Steven Gutman, director of the FDA’s Office of In Vitro Diagnostic Device Evaluation, said in a statement. “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.”
He said the MammaPrint clearance “takes into account the development of these innovative technologies and ensures public health by carefully evaluating their performance."

"Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice," FDA Commissioner Andrew von Eschenbach said in the statement.
Within two months, the FDA will publish a special controls guidance that will lay out the data types required to support genetic profiling for breast cancer claims.
Agendia’s test is already being marketed in Europe, South America, and Africa. The company recently agreed to an Australian distribution deal with Medvet.