NEW YORK (GenomeWeb News) - Agendia has begun the US roll-out of its MammaPrint breast cancer test, which is aimed at helping physicians predict the likelihood of cancer metastasis, through agreements with two university reference centers.
Agendia COO Jan Groen said in a statement that the first US centers offering the test are the University of California at San Francisco’s Medical Center at Mount Zion and the Baylor College of Medicine’s Dan L. Duncan Cancer Center.
In addition to the two reference centers, the company is offering the test to physicians through a mail-in system, company CEO Bernhard Sixt told GenomeWeb Daily News sister publication BioArray News.
Sixt said that doctors can submerge a tumor sample into a vial provided by RNARetain and send it via FedEx to Agendia's labs in Amsterdam. RNARetain is an RNA-stabilizing solution that allows tumor biopsies to be shipped without the need for freezing or cooling. Doctors will receive their results within seven to ten days after the biopsy is taken, he added.
The MammaPrint was the first in vitro diagnostic multivariate assay device approved by the US Food and Drug Administration since the agency released a draft guidance that described such products in 2006.