Agendia consigue el cabeceo del FDA para la prueba del cáncer de pecho

por Lauren Dubinsky, Senior Reporter | February 12, 2015
Women's Health
Agendia announced on Tuesday that its MammaPrint breast cancer recurrence test in formalin-fixed paraffin embedded (FFPE) tissue received FDA approval. The test assesses a patient’s risk of a return of breast cancer.

Unlike other tests on the market, MammaPrint can apply to every age group and is not limited by estrogen or HER 2 receptor status. The additional information helps physicians select the most effective treatments for their patients.

“The test result eliminates the ambiguity of the ‘intermediate result’ seen in other test platforms, and in concert with other factors, facilitates a decision by both patients and physicians about the relative benefit of chemotherapy and endocrine therapy,” Dr. Jan Egberts, CEO of Agendia, said in a statement.

The test was involved in a five-year clinical outcome study called RASTER. It found that patients with a “low risk” score had a 97.7 percent chance of being free of cancer at five years and patients with a “high risk” score had an 88.5 percent chance of being cancer free.

In July 2014, the FDA stated that it planned to regulate laboratory-developed tests (LDT) by publishing a risk-based oversight framework. The announcement was in response to the non-approved tests on the market that may have the potential to generate inaccurate test results.

“We are hopeful that once this enforcement is operationalized, it will eliminate the unfair commercial advantage currently enjoyed by vendors whose claims have not been subject to the rigorous FDA review and approval process,” Egberts said in a statement.

This FDA clearance may mean that more physicians will select MammaPrint over the other tests. “Doctors and patients typically rely on a number of factors when selecting a clinical test,” Dr. Massimo Cristofanilli, a medical oncologist and director of the Jefferson Breast Center and Clinical Program at Sidney Kimmel Cancer Center at Thomas Jefferson University, said in a statement. “The FDA clearance provides reassurance that tests have been sufficiently reviewed and validated and are clinically indicated and useful.”

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