FDA Cleared Breast Cancer Prognosis Test Available to U.S. Patients

December 13, 2007 - Agendia’s breast cancer prognosis test, MammaPrint, is now available to U.S. patients after receiving two clearances from the FDA.

The first clearance in February of this year cleared MammaPrint as an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) for use in breast cancer prognosis. In June of this year, Agendia received a second clearance for the test in conjunction with RNARetain, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling.

According to Neal S. Goldstein, M.D., Director, Molecular Oncology and Advanced Diagnostics Laboratory of William Beaumont Hospital in Royal Oaks, Michigan, MammaPrint is applicable for both ER positive and ER negative breast cancers as there is no standard determining the ER status.

“In addition, MammaPrint reportedly encompasses many genes and, as cancers are complex, the clinical utility of assays using smaller numbers of genes is dubious,” he said.

For more information: www.agendia.com