Guidelines now include both of Agendia’s genomic assays, MammaPrint^® and BluePrint^®

Agendia^®, Inc. announced today that the company’s 80-gene molecular subtyping assay, BluePrint^®, is now included in the latest version of German Gynecological Oncology Group (AGO) guidelines. The assay was added to the list of predictive factors for neoadjuvant chemotherapy decision making.

Agendia’s MammaPrint^® was added to the AGO guidelines in 2017, with level 1B medical evidence for identification of patient subgroups who can potentially forgo chemotherapy for breast cancer. MammaPrint was also added to the list of prognostic and predictive factors for extended endocrine therapy in the 2023 AGO guidelines. The two tests will be offered together to help inform the overall treatment of patients. The AGO guidelines for 2024 have been published and can be found here.

AGO is a joint expert group consisting of gynecological oncologists specialized in breast cancer and interdisciplinary members specialized in pathology, radiologic diagnostics, medical oncology and radiation oncology. The group consistently prepares and updates evidence-based recommendations for the diagnosis and treatment of patients with early and metastatic breast cancer and presents these recommendations in a yearly publication.

“We are pleased to have BluePrint included in the AGO guidelines, supported by the test’s unique ability to determine a patient’s response rate to neoadjuvant chemotherapy and inform their treatment regimen based on their tumor subtype,” says Professor Marc Thill, PhD, MD, Clinic for Gynecology and Gynecological Oncology, Agaplesion Markus Hospital, Frankfurt am Main. “The insights provided by BluePrint in the neoadjuvant setting help us make decisions in the important early days of diagnosis – a time that is crucial for care teams to have as much information as possible. We look forward to further research and clinical work using this valuable test.”

BluePrint has gained clinical validation through the NBRST trial (NCT01479101), which was designed to demonstrate the utility of both MammaPrint and BluePrint in the pre-operative treatment setting. The study highlights BluePrint’s ability to accurately predict the likelihood of pathological complete response to neoadjuvant chemotherapy treatment and in reclassifying patients into different molecular subtypes to help identify tumor sub-group and potential outcomes to treatment.

“The inclusion of BluePrint in the German AGO guidelines is a significant milestone for Agendia, but most importantly, for the women in Germany who will benefit from its crucial insights,” said William Audeh, MD, MS, Chief Medical Officer of Agendia. “We look forward to the global impact this will have on the increasing clinical availability of BluePrint and on the physicians who will use this test to confidently decide the best treatment regimen for each of their patients. We are grateful to the experts who have deemed BluePrint a necessary addition to the standard of care for patients with breast cancer.”

About Agendia

Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint^® + BluePrint^®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment.

Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer.

About BluePrint

BluePrint® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint® measures the activity of 80 key genes that are involved in a tumor's growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman's tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.

About MammaPrint

MammaPrint® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman’s risk of distant metastasis, MammaPrint® provides critical answers that help inform the future of a woman’s treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint® listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories – ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life’s plans.

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