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Multiple International Breast Cancer Guidelines Confirm Use of Agendia Tests for Prognostic, Predictive Information in Cancer Treatment Decisions
Date:9/9/2013

IRVINE, Calif. and AMSTERDAM, Sept. 9, 2013 /PRNewswire/ -- Agendia, a leader in molecular cancer diagnostics, today announced that multiple established international breast cancer treatment guidelines confirmed that Agendia's MammaPrint® tests, the leading product in Agendia's Symphony suite of breast cancer tests, significantly augment prognostic and predictive information in making key cancer treatment decisions. The updated clinical practice guidelines, published in the August edition of Annals of Oncology, were provided by the European Society of Medical Oncology (ESMO), the Japanese Society of Medical Oncology (JSMO) and the St. Gallen International Breast Cancer Conference Expert Panel.

MammaPrint was the first, and remains the only, breast cancer In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to have received FDA clearances based on the FDA's rigorous de-novo 510K process. MammaPrint, as a prognostic stratification tool, has a 98.9% accuracy in classifying patients as 'Low Risk' or 'High Risk' and technical reproducibility of 98.5%. A number of pivotal clinical studies have highlighted the value of this next generation assay in providing a higher level of precision in treatment decisions for early breast cancer.

"We are seeing a progressive recognition of our technologies by the panels of international experts and their guidelines," said Agendia CEO David Macdonald. "It is very rewarding to see that multiple thought leaders and industry guidelines throughout the world now include our MammaPrint test. We are working with all of our physician partners in adopting this clinical advantage for their patients. Third party payors are seeing the clinical and economic benefit of using a more precise instrument for their insured lives."

Specifically, the ESMO and JSMO guidelines included:


    SOURCE Agendia
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