Agendia Publishes Unprecedented Full Genome Dataset from MINDACT Trial for the Advancement of Translational Research in Communications Biology

NEW YORK, NY, UNITED STATES - Jul 27, 2020 - Agendia, Inc., a world leader in precision oncology for breast cancer, today announced the publication of MINDACT trial data in the July 27 issue of Communications Biology, a Nature Publishers Journal. In the largest data set seen to date, the study yielded a full transcriptome array for each tumor and demonstrated the successful removal of technical variation in gene expression profiles while retaining expected biological signals. The resulting dataset could serve as an invaluable tool to discover or test gene expression signatures in the Company’s quest to better elucidate the complexities of breast cancer.

The paper, entitled, “Controlling technical variation amongst 6693 patient microarrays of the randomized MINDACT trial,” is available online here.

“As part of our mission to bring patients and their doctors the data they need to make treatment decisions, we continue to conduct a number of studies and push research within our existing trials to ensure that our diagnostic tests, MammaPrint® and BluePrint®, offer reliable and actionable results,” said Annuska Glas, PhD, Vice President of Research and Development at Agendia. “This is a major research and development milestone, achieved over 13 years, that will be used in future studies to help patients and physicians better understand breast cancer.”

Gene expression data obtained in large studies are promising but in general are prone to technical variation, and removal of these variations is essential to avoid inaccurate conclusions. The publication provides a robust resource how for ensuring that initial variation affecting the full transcriptome expression data of a large dataset can be adjusted by removing over-time technical variations without losing biological signals for future analysis purposes.

The paper concluded that the analysis pipeline for this unprecedented achievement and sample size is entirely reproducible, and both adjusted and unadjusted breast cancer data sets are available and ready-to-use for translational research.

“We are happy to make this data and our process accessible for the community working to uncover every complexity of breast cancer,” said Laura van’t Veer, PhD, Chief Research Officer and Co-Founder of Agendia.

The multi-faceted, real-world data library being built for the MINDACT trial underscores Agendia’s commitment to both long-term and immediately actionable research and dedication to consistently pushing the boundaries of previous findings to improve patient outcomes.

About the MINDACT Trial

MammaPrint, the 70-gene risk of recurrence assay for patients with early-stage breast cancer, is supported by level 1A clinical evidence from MINDACT, a landmark trial sponsored by the EORTC (EORTC-10041/BIG3-04). The study found that clinically high-risk patients with a MammaPrint Low Risk result could safely de-escalate treatment and forgo chemotherapy. Long-term follow-up data from MINDACT, presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO), confirmed and built upon the findings published in the New England Journal of Medicine in 2016.

The MINDACT trial enrolled 6,693 breast cancer patients. At the five-year follow-up mark, the trial showed that tumor analysis and reclassification by the MammaPrint 70-gene expression signature enabled a 46 percent reduction in the use of chemotherapy for clinically high-risk patients that were reclassified by the genetic assay to be genomically Low Risk. Nine-year follow-up data will be published in depth later this year, and confirm MINDACT as a positive de-escalation study for chemotherapy and continues to demonstrate MammaPrint’s clinical utility when determining a breast cancer patient’s need for chemotherapy.

View trial information here.

About Agendia

Agendia is a precision oncology company committed to improving clinical outcomes and informing the journey for patients with early stage breast cancer. The company currently offers two commercially available genomic profiling tests, processed through its state-of-the-art facility in Irvine, California. Agendia also provides a next generation sequencing kit for use by local laboratories outside of the United States.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the first FDA-cleared risk-of-recurrence test backed by peer-reviewed, prospective outcome data and included in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is a commercially available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint and BluePrint provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. By developing evidence-based, novel genomic tests, Agendia aims to support the evolving clinical needs of breast cancer patients and their physicians.

Agendia’s assays can be ordered on core biopsies or surgical specimens with results provided in as little as 5-7 days to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.