Agendia, Inc. Provides Review of Successful 2024

Agendia®, Inc. today provided a topline review of the company’s key milestone achievements in 2024. These updates include significant inroads in expanding market access, product innovation, commercial growth, advancements in research, as well as key partnerships and awards.

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“In the past year, Agendia has made great progress in advancing the field of precision oncology and genomic testing. We have seen success across multiple aspects of our business, including global expansion and clinical adoption of our proprietary assays, MammaPrint^® and BluePrint^®, advancement of our clinical milestones, expansion of our global market access, and formation of strong partnerships with professional and advocacy organizations,” said Mark R. Straley, Chief Executive Officer of Agendia. “Our mission of empowering patients and their care teams with biology-based insights for optimal treatment planning remains the hallmark of our patient-first philosophy. Agendia’s exceptionally talented team is committed to bringing the power of genomic tests to physicians and their patients and providing clinical insights for improved outcomes. Execution of our key priorities will drive continued momentum in 2025.”

The following are key milestones achieved by Agendia in 2024:

Market Access

• Achieved Year-over-Year growth and share expansion as the commercial team worked with customers to continuously provide biology-based insights to help guide treatment decisions.

• Expanded relationships within the payor medical policy community by participating in numerous provider programs and presentations, which led to coverage of our tests by more than 90% of payors in the US, as well as expanded coverage to include core biopsy samples as part of the existing MammaPrint coverage guidelines.

• Obtained inclusion for Blueprint in the 2024 version of the German Gynecological Oncology Group (AGO) guidelines as a predictive factor for neoadjuvant chemotherapy decision making.

• Received certification from the EU In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including MammaPrint^® FFPE Microarray, BluePrint^® FFPE Microarray, and MammaPrint and BluePrint NGS Kit. This certification has been extended to include predictive claim.

Product Growth and Innovation

• Presented new clinical data on Agendia’s Research Use Only test, ImPrintTN from the I-SPY 2 trial in patients with triple negative breast cancer at the 14^th European Breast Cancer Conference, showcasing its utility in providing more accurate response predictions to common immunotherapy regimens.

Clinical Milestones and Advancements in Research

• Announced the first patient to use MammaPrint in the DEBRA Trial, as an additional enrollment biomarker.

• Advanced the clinical utility of MammaPrint and BluePrint through presentations and abstracts at several conferences, including:
  • The 41st Annual Miami Breast Cancer Conference: Highlighted new data from the ongoing prospective observational FLEX Study in two poster presentations.
  • American Society of Clinical Oncology (ASCO): Presented a robust suite of data on MammaPrint and BluePrint, including two oral sessions and three posters around their utility in predicting 3-year outcomes in patients when treated with neo/adjuvant chemotherapy and their ability to characterize the immune active state of MammaPrint High Risk tumors. The other ASCO abstract was ACT/TC, demonstrating the ability to identify high risk patients who have better outcomes with an anthracycline regimen.
  • San Antonio Breast Cancer Symposium (SABCS): Presented two poster spotlight presentations, one late-breaking poster, and two posters on the expanding clinical utility of our MammaPrint and BluePrint assays in providing reliable guidance for therapeutic decisions in early-stage breast cancer.

• Highlighted MammaPrint and BluePrint utility in extended endocrine therapy selection and decision making:
  • Published data from the NSABP-B42 study evaluating MammaPrint’s utility in predicting benefit of extended endocrine therapy in patients with early-stage breast cancer in the June issue of the Journal of Clinical Oncology.
  • Published a pivotal secondary analysis in JAMA Network Open from the IDEAL randomized Phase 3 clinical trial on MammaPrint’s utility in prediction of extended endocrine therapy benefit in post-menopausal patients with early-stage breast cancer.

• Successfully enrolled over 18,000 patients with early-stage breast cancer in the FLEX Study, which expects to enroll 30,000 from a diverse patient population.

Prestigious Partnerships and Awards

• Finalized protocol design and implementation of a Phase 3 trial evaluating the use of immunotherapy in patients who were classified as MammaPrint High 2, following the announcement of a collaboration with the National Cancer Institute and SWOG Cancer Research Network in late 2023.

• Honored for her pioneering work in molecular cancer diagnostics and breast cancer research over the past 30 years, Agendia’s co-founder, Prof. Dr. Laura van ’t Veer, received three distinct honors, including The Luigi Castagnetta Award, a keynote lecture at the Amsterdam Antoni van Leeuwenhoek Hospital’s Anniversary Symposium, and the William L. McGuire Memorial Lecture Award at the 2024 San Antonio Breast Cancer Symposium.

• Continued to build upon our strong relationships with key organizations, which were all patient advocacy groups, including sponsorships with the following groups:
  • Dandelion Toolkit^®
  • Look Learn Locate^®
  • Living Beyond Breast Cancer®
  • Susan G. Komen Foundation^®
  • Tigerlily Foundation
  • Sharsheret

“Here at Agendia, we are committed to leading the way in finding better options for personalized breast cancer management and improving support for those affected by this all too common disease,” said William Audeh, MD, MS, Chief Medical Officer of Agendia. “We are incredibly proud of what the team has accomplished this year and how we have contributed meaningful clinical information. As we look ahead into 2025, we are excited to unveil critical insights that will continue to transform medical care and outcomes for physicians and their patients.”

For the latest updates on Agendia’s clinical progress, please visit www.agendia.com.

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.

Agendia was founded in 2003 and is headquartered in Amsterdam with its state-of-the-art laboratory facility located in Irvine, CA. 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 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.

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.

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