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.
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.
Westwicke/ICR Healthcare PR
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
H.I.G. Realty Invests in Production Studios & Content Hub in Madrid15.1.2021 11:00:00 EET | Press release
H.I.G. Capital, LLC ("H.I.G."), a leading global alternative investment firm with $43 billion of equity capital under management, announced today that one of its affiliates has invested in Madrid Content City, an approximately 140,000 square meter hub with state of the art audio-visual facilities, including production studios, production & post-production technical facilities, and a university focused on media studies. H.I.G. continues to add to its sizeable portfolio of real estate assets across Europe, consisting of both equity as well as debt investments, with a particular focus on its target market of value-added small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Europe Realty Partners, commented: “Madrid Content City will benefit from strong secular tailwinds underpinned by the boom in content production. The state-of-the-art studios and related facilities, the exceptional multinational tenant line-up with long term leases, and its critical mas
Eurofins, the global leader in analytical testing, expands worldwide face mask testing & certification capabilities15.1.2021 09:30:00 EET | Press release
Since the start of the pandemic Eurofins (Paris:ERF) has tested thousands of models of surgical and hygienic masks and provided best-in-class speed and certification for PPEs globally, enabling these critical products to get market as fast as possible. Eurofins has developed global leading testing capabilities and certification services in the North America, Europe and Asia ensuring that PPE manufacturers are able to provide the indispensable support needed in the fight against the coronavirus. As of today, Eurofins is one of the few GLP certified and ISO/IEC 17025 accredited laboratory networks to fully cover all testing requirements for surgical/medical and hygienic masks by the FDA, EU regulations and many international and country-specific directives and guidelines such as CEN, CE Marking, ISO, ASTM or OECD. Our robust portfolio for masks includes globally accepted, safety and performance testing, virucidal, bacterial filtration, particle filtration, differential pressure, biocompa
TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport® (abobotulinumtoxinA) in five therapeutic indications15.1.2021 09:00:00 EET | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of Dysport® (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.1-27 Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilit
Velodyne Lidar Commends NHTSA Plan to Update NCAP14.1.2021 23:58:00 EET | Press release
Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today commended the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) plan to update to its New Car Assessment Program (NCAP). The NHTSA proposal would add four advanced driver assistance system (ADAS) capabilities to the NCAP, keeping pace with evolving safety technologies and providing much-needed information to consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005992/en/ Images show vehicle with lidar-based PAEB stopping before adult target @ 50% overlap (above) and vehicle with camera and radar-based PAEB crashing into adult target (below). (Photo: Velodyne Lidar, Inc.) NCAP is the U.S. Government’s premier consumer information program for evaluating vehicle safety performance. The NHTSA proposal to add ADAS technologies to the NCAP includes pedestrian automatic emergency braking, lane keeping support, blind spot warning and
Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 202014.1.2021 21:15:00 EET | Press release
Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)i, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe. "Despite the global challenges in 2020, Veristat continued to advance its mission of helping clients achieve regulatory approval of novel medical therapies," stated Patrick Flanagan, Chief Executive Officer at Veristat. "Now, more than ever, Veristat is focused on providing expert guidance to facilitate the rapid approval for therapies that improve the lives of patients and their families around the world." Ve
Tigo Energy Raises $20 Million in Funding14.1.2021 19:33:00 EET | Press release
Tigo Energy, Inc., the worldwide leader in Flex-MLPE (Module Level Power Electronics) today announced a $20 million round of investment, led by Energy Growth Momentum. “2020 has been a breakout year for Tigo and 2021 has the potential for even greater success,” stated Zvi Alon, Chairman and CEO of Tigo. “We are excited to have the EG Momentum team’s support and their working capital will enable us to better serve our current customer base and invest in the future expansion with new customers, new partners and new projects.” The investment will be used to improve upon existing products and develop next generation solutions that maximize returns for PV customers. A portion of the new funds will be used to efficiently and effectively scale. Tigo’s growth has accelerated significantly recently as the company’s products have reached more customer segments and countries throughout the world. With over 40,000 installations in over 100 countries on all 7 continents, Tigo systems generate more
Samsung’s Newest 108Mp Mobile Image Sensor with Advanced Features Captures More Details and Produces Sharper Results14.1.2021 19:00:00 EET | Press release
Samsung Electronics Co., Ltd., a world leader in advanced semiconductor technology, today introduced its latest 108-megapixel (Mp) mobile image sensor, Samsung ISOCELL HM3. With a wide spectrum of advanced sensor technologies, the HM3 can capture sharper and more vivid images in ultra-high resolution with faster auto-focus and extended dynamic range. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005430/en/ ISOCELL HM3 - 108 megapixel image sensor (Graphic: Business Wire) “While a pixel is just a single dot of color, when in millions, these dots can be transformed into stunning snapshots of life. With more pixels, images are sharper, with fuller details that can maintain their integrity even when enlarged. Samsung has been at the forefront of bringing the most pixels to mobile image sensors as well as various supporting technologies that take sensor performances to the next level,” said Duckhyun Chang, executive vice p
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