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European Group Gives Highest Level Label to Agendia MammaPrint

NEW YORK (GenomeWeb) – Agendia said Tuesday that updated guidelines from the European Group on Tumor Markers named the firm's MammaPrint 70-gene signature test "as the first and currently the only multigene test of its kind deemed to have level 1A evidence for its clinical use."

The EGTM is a group of European-based cancer thought leaders consisting of clinical biochemists, pathologists, physicians, surgeons, and scientists from the diagnostics industry with an interest in tumor markers. Its updated guidelines were published recently online in the European Journal of Cancer.

Multigene tests, such as MammaPrint, play an essential role in the management of patients with breast cancer. In making its recommendations, the EGTM examined the validation of these tests in prospective or prospective-retrospective trials, systematic reviews, pooled and meta-analyses of biomarker studies, and relevant guidelines published by other expert panels, Agendia said.

Based on this review, MammaPrint is the first and currently the only multigene test to receive the highest level of evidence of 1A, the firm said, adding that guidelines, such as those provided by EGTM, have the potential to impact the treatment of thousands of patients globally.

Earlier in March, Agendia said that its MammaPrint 70-gene signature test had received the highest medical evidence level 1A label in German Association of Gynecological Oncology (AGO) guidelines for breast cancer care in Germany.

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 said that the recent EGTM guidelines recognized other multigene tests such as Genomic Health's Oncotype DX, NanoString Technologies' Prosigna, and Myriad Genetics' EndoPredict with level 1B evidence.

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.