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.

Results published at the annual San Antonio Breast Cancer Symposium, said that Abraxane in combination with Xeloda may be an effective treatment option for patients with metastatic breast cancer.Abraxane is a newer form of Taxol that uses albumin, a natural protein found in the body, to deliver high concentrations of the active ingredient into the cancer cells and has fewer side effect than Taxol. Abraxane treatments last around 30 minutes compared with 3 hours for Taxol.

Researchers conducted a small clinical trial that included 38 patients with metastatic breast cancer. Complete disappearance of cancer was achieved in nearly 9 percent of patients. Partial responses were achieved in about 44 percent of patients. Disease stabilization was seen in almost 33 percent of study participants.

Even though the study was a small one, researchers conclude that it appears that treatment with Abraxane and Xeloda may be effective for patients with metastatic breast cancer.