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

Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera29.8.2026 00:40:00 CEST | Press release

MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve FatigueApproval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32 Takeda (TSE:4502/NYSE:TAK)announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260824773270/en/ MIMRYLO Logo MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the tot

Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology28.8.2026 16:00:00 CEST | Press release

Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828688510/en/ Inside the Institute As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray me

BLK: Portfolio Company of Enry’s Island S.p.A., Lists on Euronext Dublin28.8.2026 15:34:00 CEST | Press release

Enry’s Island S.p.A. (WBAG:EIOS), an international venture builder with headquarters in the Tremiti Islands and the Metaverse, announces that BLK Global PLC, one of the portfolio companies within its ecosystem, has successfully completed its admission to trading on Euronext Access Dublin. Trading in the company’s shares commenced on Friday, July 31, 2026, under ticker BLKX and ISIN GB00BPSKS130. BLK was one of the thousands of applications received by Enry’s Island which, following an assessment process based on the Enry’s Model, was selected for a one-year incubation and acceleration programme. The programme supported the company through its subsequent growth stages, ultimately leading to its current stock market listing. Alessandro Pacciana, Investor Relations Manager of Enry’s Island S.p.A., said: “BLK’s listing is the second stock market listing in two years among Enry’s Island’s portfolio companies, while Enry’s Island itself is the world’s first listed venture builder. We are pro

Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations28.8.2026 11:00:00 CEST | Press release

Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026 The approval is based on data from the Phase 3 RISE-PD trial where Hopledo® demonstrated a significant increase in Good ON time compared with immediate-release LD/CD with fewer daily doses and a comparable safety profile Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely

MTG-I2 Safely in Orbit, Unlocking Faster and Sharper Weather Monitoring Across Europe28.8.2026 10:16:00 CEST | Press release

The Meteosat Third Generation Imager 2 satellite (MTG-I2) has successfully passed its first critical post-launch milestones, completing the first full Meteosat Third Generation constellation in orbit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828243790/en/ Credit: Arianespace livestream The imager satellite MTG-I2 is safely in orbit and operating as expected following its successful launch yesterday at 22:11 CEST on board an Ariane 6 rocket from Europe’s Spaceport in French Guiana. Our teams have established communication with the spacecraft, which has also deployed its solar panels to ensure its autonomous production of energy. MTG-I2 is in perfect shape to start its Launch and Early Operations Phase that will bring it to a higher orbit, 36 000km above Earth over the following two weeks, where a longer period of calibration and validation of its instruments will begin. This summer’s extreme weather and wildfires hav

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