Women at high risk have about twice the recurrence rate as women in the low risk category. The test predicts who is in the low risk category with at least 90% accuracy. For those in the high risk category, only 23% actually got a recurrence within five years, so it is possible the test overestimates this group. The company and the FDA advise that doctors and patients use the findings with other information to choose a form of therapy. An FDA spokesperson was quoted as saying "You can't go all the way to the bank with this test." But it is an important step in tailoring treatment to the individual patient.
A California company, Genomic Health (NASDAQ:GHDX) already offers a test to US patients under FDA rules that allow some test to be sold without approval (see Molecular Diagnostics: The New New Thing?). Oncotype DX predicts whether a woman will benefit from chemotherapy. It is widely reimbursed and performed in a CLIA laboratory. Unlike Genomic Health, Agendia asked for FDA approval for its test. The approval was based on a study of 302 women in Europe, who were suffering from early disease and under 61 years of age.
Agendia is located in Amsterdam, the Netherlands. It has three gene expression analysis-based diagnostic tests on the market. In addition to the two already mentioned, it also markets DiscoverPrint®, a test to predict responders and non-responders to a new cancer drug by analyzing their tumors with DNA microarrays.
Agendia maintains close ties with several leading European academic centers and has access to a unique tissue bank at the University of Amsterdam. It recently signed a distribution agreement with Medvet Science in Adelaide, Australia for distribution of MammaPrint in Australia and the South Pacific Region. Late last year, Agendia signed a similar agreement with Teva&Tuteur of Buenos Aires, Argentina, for Argentina and Paraguay.