The U.S. FDA has cleared Agendia’s MammaPrint breast cancer diagnostic test. MammaPrint is a gene expression profiling service to assess the risk of recurrence in breast cancer patients. According to the company, the test represents a U.S. regulatory milestone as the first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire market clearance from the FDA. It also represents the agency’s first move to standardize multi-gene expression tests.
By using this type of test, women with early stage breast cancer could gain valuable information to assist them and their physicians in forecasting the possibility of a relapse within five or 10 years. Such information could help determine the course of treatment that is taken, according to an Associated Press report.
The FDA’s Dr. Steven Gutman told the AP that these types of tests are highly sophisticated and should be used very carefully by physicians.
Previously the FDA hasn't required a structured review and approval for these tests. The agency is now considering whether other similar tests on the market should be formally reviewed, AP reports.
Agendia’s Dr. Bernhard Sixt, chief executive officer stated that "this type of regulatory review benefits breast cancer patients and provides regulatory clarity to the medical community. At present, MammaPrint is the first cleared IVDMIA which can be marketed in the US in compliance with these new FDA guidelines. We are exploring ways to make this product available in the US."
MammaPrint is already available for sale in Europe.
This week, the FDA has scheduled a public hearing to review draft guidance regarding IVDMIAs. The FDA said it intends to regulate multi-gene molecular diagnostics tests so that safety and efficacy can be regulated. The agency also wants to make sure that IVDMIA results can be easily interpreted by physicians, Agendia said in a release.