NEW YORK (GenomeWeb) – Agendia said today that its MammaPrint 70-gene signature test that measures risk of recurrence in breast cancer has received the highest medical evidence level 1A label in German Association of Gynecological Oncology (AGO) guidelines for breast cancer care in Germany.
AGO, a joint expert group of the German Society of Gynecology and Obstetrics and the German Cancer Society, publishes an annual update for cancer clinicians entitled "Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer." In the guideline published on March 2, an AGO Mamma Commission included MammaPrint as having the highest level of medical evidence for the identification of patient subgroups with a low genomic risk of recurrence to justify withholding potentially unnecessary chemotherapy.
The AGO guidelines referenced the MINDACT trial, which included almost 7,000 patients from 112 institutions in nine countries, and was published in the New England Journal of Medicine in August 2016.
MammaPrint achieved clinical validation in that trial, Agendia said. Its results showed that a large number of women with breast cancer could be spared chemotherapy and still achieve excellent outcomes, free of recurrent disease.
The firm noted that 46 percent of patients identified as being at high risk of recurrence based on clinical indicators received a low-risk genomic test result, and may not benefit from chemotherapy.
Agendia launched MammaPrint in Europe in 2004 and introduced it to the US market in 2007 after garnering 510(k) clearance from the US Food and Drug Administration. It became the first complex genomic breast cancer recurrence test to receive such clearance.
"We commend AGO for recognizing the evidence supporting MammaPrint and look forward to its inclusion in additional guidelines as we move forward," Agendia CEO Mark Straley said in a statement.Â