MammaPrint Assay Validated
The recent meeting of the AACR/NCI/EORTC Conference Molecular Targets and Cancer Therapeutics: Discovery, Biology and Clinical Applications, held in San Francisco, included a presentation describing the value of the MammaPrint breast cancer prognosis test in older patients with this malignancy. Findings indicated that the test is a powerful prognostic tool to identify risk of metastatic disease in older patients, as described in the press release from the test manufacturer, Agendia BV.
The MammaPrint is a microarray- based in vitro diagnostic multivariate index assay (IVDMIA), the first test of its kind to receive marketing approval from the Food and Drug Administration. The test measures 70 different genes to determine the likelihood that breast cancer will recur. Gene expression is measured in breast tissue procured during surgery. Expression results are extrapolated into an algorithm to determine a patient’s risk for metastases.
MammaPrint was originally approved by the FDA in February 2007. That approval for the test was as a breast cancer prognostic tool. The product was granted a second indication in June for use of the test in conjunction with RNARetain. That product is an RNA stabilizing solution which allows tumor specimens to be shipped at ambient temperature levels, simplifying the tissue handling and preparation processes.
The recent data presentation provides Agendia BV with sufficient data to seek an additional approval for the test from the FDA. The company intends to seek clearance to use the MammaPrint diagnostic tool for patients over the age of sixty.
January 4, 2008 Related topics: Laboratory, Laboratory Equipment, Diagnostic, Surgery, Hematology & Oncology