Business Wire

CA-AGENDIA

9.12.2020 19:07:16 CET | Business Wire | Press release

Share
FOCUS Study Shows MammaPrint® Accurately Identifies Extremely Indolent Cancers

Agendia, Inc., a world leader in precision oncology for breast cancer, presented data from the FOCUS trial that show the clinical utility of MammaPrint® in older breast cancer patients at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020).

The poster, The 70-gene signature (MammaPrint) accurately predicts distant breast cancer recurrence risk in older patients , outlines data from the FOCUS trial, a population-based cohort of over 2,000 people that included all consecutive breast cancer patients over 65 years old diagnosed between 1997 and 2004 in the Comprehensive Cancer Center region West, the Netherlands. The purpose of the study was to assess the stratification of breast cancers by MammaPrint in women over 70 years of age.

Treating older breast cancer patients can be challenging, as they generally have more indolent tumors and a higher likelihood of developing additional conditions that negatively affect their health than younger patients. Current treatment guidelines recommend therapy for these patients based on clinicopathological risk, but these factors are insufficient for accurate determination of prognosis. MammaPrint has been shown to accurately predict recurrence in younger women with breast cancer, and for this study, the 70-gene signature was assessed in women 70 years and older with breast cancer. MammaPrint was found to accurately stratify patients according to their 10-year distant recurrence free interval, as previously demonstrated in younger populations.

Further, the results in the poster show that even clinically high risk patients who were classified as MammaPrint UltraLow Risk – meaning they can have excellent survival without chemotherapy and only limited or no tamoxifen treatment – did not develop any recurrent disease 10 years after diagnosis, opening up treatment options and considerations for doctors and their patients, allowing them to make more informed decisions about the path ahead.

“These data show the importance of knowing everything you can about a cancer, especially when you are working with older patients who may be more fragile or susceptible to harsh treatment,” said Dr. Gerrit-Jan Liefers, Surgeon, Head of the Department of Surgical Oncology of Leiden University Medical Center and the principal investigator of the FOCUS study. “We see genomically low risk patients do very well long-term, which gives us confidence to de-escalate their treatment to something more tolerable and achieve the same success, even if they are clinically high risk. We are pleased to make these data available to the breast cancer community and show the importance of research in all types of breast cancer patients.”

For post-menopausal women who are identified as MammaPrint UltraLow Risk, these results have meaningful implications for their treatment paths.

“This analysis of the FOCUS cohort adds to the growing body of data demonstrating the validity of MammaPrint’s UltraLow Risk threshold,” said Laura Esserman, M.D., Director of the UCSF Carol Franc Buck Breast Care Center, and winner of this year’s Brinker award for Scientific Distinction in Clinical Research. “The data confirm our findings from the STO-3 Trial , as well as data from the IKA tamoxifen trial cohort presented at ESMO earlier this year for node negative hormone positive breast cancer patients. These data should give confidence to patients and their physicians that the UltraLow molecular signature is associated with excellent prognosis even without extended endocrine therapy. De-escalation based on biologic features can be used to reduce the length of treatment, providing more precise treatment. Most important, the UltraLow signature can be used to substantially reduce the burden of treatment in those destined not to benefit. And certainly this can make a huge difference in the quality of life and the anxiety experience over the diagnosis.”

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

About Agendia

Agendia is a precision oncology company headquartered in Irvine, California, 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.

Agendia develops evidence-based novel genomic tests and forges partnerships with groundbreaking companies to develop next-generation digital treatment tools. The ongoing research builds an arsenal of data that 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 to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com .

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Invivoscribe® Expands IVDR Portfolio with IdentiClone® Dx IGH Assay Certification26.3.2026 06:13:00 CET | Press release

IdentiClone® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). Commercial availability of the IVDR-certified assay is anticipated by early April 2026. The IVDR replaces the former In Vitro Diagnostics Directive (IVDD), introducing significantly more stringent requirements for clinical evidence, performance evaluation, traceability, and post-market surveillance. Under IVDR, in vitro diagnostic devices are classified according to risk from Class A (lowest risk) to Class D (highest risk). Class C devices, such as IdentiClone Dx IGH, are considered high-risk tests that play a critical role in disease diagnosis an

Dominican Republic Drives Modernization of Electronic Passports Under the Leadership of the Thales - MIDAS Consortium25.3.2026 23:22:00 CET | Press release

The General Directorate of Passports, together with the Presidency of the Dominican Republic, are leading the transformation of the country’s passport issuance system with a new, secure, efficient document aligned with international standards.In 2025, the Thales-MIDAS consortium was awarded the contract to develop, issue, and personalize a modern, secure, and highly reliable travel document for Dominican citizens, incorporating additional cybersecurity measures. The Presidency of the Dominican Republic, through the General Directorate of Passports, issued the country’s first electronic passport as part of its strategy to modernize and strengthen national security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324368065/en/ Passport of the Dominican Republic The new document was developed in partnership with Thales, world leader in advanced technologies for the Defense, Aerospace, Cybersecurity, and Digital sectors, and M

3D Systems Achieves Full-Scope EU MDR Certification, Accelerating European Launch of NextDent® Jetted Denture Solution Targeted for Summer 202625.3.2026 17:20:00 CET | Press release

Certification Marks Major Milestone in Strategic Dental Growth Initiative Addressing Straightening, Protection, Repair and Replacement of Teeth 3D Systems (NYSE: DDD) today announced it has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745. The certification was attained on Monday, March 16, 2026. This milestone confirms that the Company’s quality system, technical documentation, and clinical evidence meet the most rigorous regulatory requirements in the medical device sector. With the MDR certificate in hand, 3D Systems will now introduce MDR-compliant product versions through a carefully coordinated, phased rollout across its dental product families and European markets. This approach ensures a smooth transition while maintaining uninterrupted product availability for customers and healthcare providers. The EU MDR certification immediately enables the introduction of innovative new materials and is a pivotal step for one of 3D Syst

Visa to Bring Privacy-Preserving Payments to Canton Network25.3.2026 17:00:00 CET | Press release

Visa is the first payments company selected to become a Super Validator on the Canton Network, where it will help banks and financial institutions bring new payment flows onchain Visa (NYSE:V), a global leader in digital payments, today announced it will join the Canton Network as the first major global payments company to serve as a Super Validator, to help extend privacy‑preserving blockchain infrastructure to banks and financial institutions around the world. Visa will be one of 40 Super Validators on Canton. That move goes straight to a core challenge for financial institutions: the same transparency that gives blockchains their appeal can clash with privacy expectations financial institutions operate under. Canton Network, a blockchain built for regulated finance, has privacy built in from the beginning, so organizations can use shared infrastructure without exposing sensitive information. As a Super Validator, Visa will help clients who choose to run and secure operations on the

ECU Worldwide Unveils XLERATE 2.0 Expansion to Bypass Asia–Europe Supply Chain Disruptions25.3.2026 14:30:00 CET | Press release

Strategic LAX gateway enables faster, predictable cargo movement through a reimagined sea–air logistics model ECU Worldwide, Allcargo Globals’ wholly-owned global subsidiary, has announced a strategic expansion of its transformative logistics solution, XLERATE 2.0, to provide a high-speed and resilient alternative to Asia-to-Europe trade lanes facing transit disruptions. Under this alternative routing, cargo is transported across the Pacific to the US West Coast, using Los Angeles (LAX) as a temporary hub. The solution leverages XLERATE 2.0’s premium, time-definite ocean services, ensuring greater transit agility and continuity. XLERATE 2.0 offers two distinct shipping solutions from China and Vietnam, providing shippers with flexibility as traditional trade arteries remain impacted by shifts in global logistics. These changes have led to reduced overall capacity and the disruption of standard sea–air services via conventional transit points. Commenting on the rollout, Simon Bajada, Re

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye