NEW YORK (GenomeWeb News) – Agendia said yesterday that it plans to seek expanded clearance from the US Food and Drug Administration for the use of its MammaPrint breast cancer prognosis test in patients over the age of 60.
The Amsterdam-based company said it has completed a study that has shown the test to be useful in assessing the risk of the recurrence of breast cancer in older, post-menopausal patients.
Agendia’s CEO, Bernhard Sixt, said in a statement that the new “independently validated” information about the test is important because the biology of breast cancer differs between older and younger people.
In February, the FDA cleared MammaPrint for safety and effectiveness for use in breast cancer prognosis under its In Vitro Diagnostic Multivariate Index Assay guidelines. The agency later cleared the test for use with Agendia’s RNARetain RNA-stabilizing solution, which allows tumor biopsies to be shipped at ambient temperatures, lowering shipping costs and allowing broader distribution of the test.
Agendia said it now plans to submit new study data to the FDA for additional clearance to include patients over age 60, though it did not provide a timeline for when it plans to file with the agency.
In the study, tumors from 100 breast cancer patients with a median age of 62 years were analyzed with MammaPrint, which used gene expression profiles to classify patients as being at either low or high risk for distant metastasis. Agendia said that the results were compared to actual outcome of disease in these patients and indicate that MammaPrint is “a very powerful tool to identify older breast cancer patients at low risk for metastatic disease.”
Agendia said it has submitted the study for publication to a clinical research journal.