Agendia has announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s MammaPrint(C) breast cancer diagnostic test. MammaPrint® is a gene expression profiling service to assess the risk of recurrence in breast cancer patients.

The US Food and Drug Administration has approved MammaPrint, a new genetic test that can help predict whether a woman’s early stage breast cancer is likely to come back after initial treatment. The MammaPrint® test uses advanced genetic technology to predict whether existing cancer will spread to other parts of a patient’s body (metastasize). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of activity of large numbers of genes in biological specimens.

“Today’s FDA clearance of MammaPrint® is a milestone for patient care and safety,” said Dr. Bernhard Sixt, Chief Executive Officer at Agendia.

“As the first test of its kind cleared by the FDA, 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,” Sixt continued.

“We are pleased about today’s FDA announcement as it signifies an important first step in standardizing IVDMIAs to ensure a safe and welcomed advancement in cancer diagnostics,” said Diane Blum, MSW, Executive Director of CancerCare.

Agendia is located in Amsterdam, the Netherlands.

When women and men have lung cancer of the same stage and are given the same treatment, the women are more likely to survive, according to the findings published in the journal of Chest.

Lung cancer “is the number one cause of cancer deaths in both men and women worldwide,” Dr. Robert James Cerfolio and colleagues from the University of Alabama at Birmingham, write.

Several studies using data from national cancer registries have shown that men and women differ in lung cancer survival. The present study was different in that it determined survival in men and women who were diagnosed with lung cancer, treated based on the same algorithm, and then followed for up to 7 years.

The study included 1,085 patients, 671 men and 414 women. There were no significant differences between the sexes in terms of race, other diseases, smoking history, lung function and the treatment received.

At 5 years, 60 percent of women were still alive compared with 50 percent of men. Moreover, women had consistently higher survival rates for all stages of disease. As to why survival was better for women, it may relate to them being more responsive to chemotherapy, Cerforlio and colleagues report.