Analysis Published in European Journal of Cancer
Use of MammaPrint genetic assay alongside clinical assessment is cost-effective versus clinical assessment alone
IRVINE, California, Aug. 25, 2020 /PRNewswire/ -- Agendia, Inc [https://c212.net/c/link/?t=0&l=en&o=2896123-1&h=1946537744&u=https%3A%2F%2Fwww.agendia.com%2F&a=Agendia%2C+Inc]., a world leader in precision oncology for breast cancer, announced the publication of multi-country cost analyses from the landmark MINDACT trial in the European Journal of Cancer, which show that adjuvant chemotherapy strategies guided by MammaPrint® deliver healthcare cost savings in five of the six countries evaluated. The 70-gene risk of recurrence assay was shown to be cost-effective in all six.
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The entire analysis, entitled "Cost-Effective Analysis of the 70-Gene Signature Compared to Clinical Assessment in Breast Cancer, based on a randomized controlled trial," can be found here [https://c212.net/c/link/?t=0&l=en&o=2896123-1&h=4177978519&u=https%3A%2F%2Fwww.ejcancer.com%2Farticle%2FS0959-8049(20)30381-6%2Ffulltext&a=here].
When MammaPrint was used to safely guide chemotherapy de-escalation in clinical high-risk, ER+/HER2- breast cancer patients, annual health system cost savings were seen in the United States ($244M) Belgium (EUR4.2M), France (EUR24.7M), Germany (EUR45.1M), and the Netherlands (EUR12.7M).
"Since its initial five-year data analysis was published in 2016, the MINDACT study has continued to prove MammaPrint's clinical utility," said Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia. "The study provides insight and additional evidence of the overall value of the test in showing the relief on healthcare systems across the globe. We are encouraged to see that MammaPrint not only saves a patient from experiencing the toxicity of chemotherapy, but also that it can save health systems the associated financial expenses."
With the growing library of findings from the MINDACT trial, sponsored by the European Organisation for Research and Treatment of Cancer (EORTC), Agendia provides patients and their physicians the data they need to make the most informed and personalized decisions about breast cancer treatment. Compared to using clinical assessment alone, the additional information provided by MammaPrint has the potential to empower physicians to de-escalate patient treatment while triggering significant cost savings for major health systems around the world.
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 de-escalate treatment and forgo chemotherapy. Long-term follow-up data [https://c212.net/c/link/?t=0&l=en&o=2896123-1&h=2624991826&u=https%3A%2F%2Fmeetinglibrary.asco.org%2Frecord%2F184901%2Fabstract&a=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 in the Fall of 2020, and further validate 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 [file://10.86.178.62/Users/tclevenger/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/L3J313MJ/MammaPrint%20is%20supported%20by%20the%20highest%20level%20of%20clinical%20evidence%20(level%201A)%20from%20MINDACT,%20a%20landmark%20independent%20trial%20published%20in%20the%20New%20England%20Journal%20of%20Medicine%20in%202016.%20MINDACT%20stands%20for%20Microarray%20In%20Node-Negative%20and%201-3%20node-positive%20Disease%20may%20Avoid%20ChemoTherapy.%20It%20was%20a%20phase%20III,%20prospective,%20randomized,%20clinical%20study%20for%20a%20breast%20cancer%20recurrence%20test%20sponsored%20by%20the%20European%20Organization%20for%20Research%20and%20Treatment%20of%20Cancer%20(EORTC-10041/BIG3-04).].
Agendia is a precision oncology company committed to bringing early stage breast cancer patients and their physicians the information they need to make the best decisions for the full treatment journey. The company currently offers two commercially-available genomic profiling tests, supported by the highest levels of clinical and real world evidence, that provide comprehensive genomic information that can be used to identify the most effective breast cancer treatment possible for each patient.
MammaPrint®, the 70-gene breast cancer recurrence assay, is the only FDA-cleared risk of recurrence test backed by peer-reviewed, prospective outcome data and inclusion in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is the only 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 and conducting groundbreaking research while building an arsenal of data that will help treat breast cancer, Agendia aims to improve patient outcomes and support the evolving clinical needs of breast cancer patients and their physicians every step of the way, from initial diagnosis to cancer-free.
Agendia's assays can be ordered on core biopsies or surgical specimens with results in as little as 5-7 days to inform pre- and post-operative treatment decisions. For more information on our assays and our ongoing trials, please visit www.agendia.com [https://c212.net/c/link/?t=0&l=en&o=2896123-1&h=2031490434&u=http%3A%2F%2Fwww.agendia.com%2F&a=www.agendia.com]
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CONTACT: Terri Clevenger, Westwicke/ICR Healthcare PR, Tel: 203.856.4326, Terri.Clevenger@icrinc.com
Web site: https://agendia.com//