Dataset of up to 10,000 full genome profiles matched with complete clinical data will provide representative resource for breast cancer research
IRVINE, CALIF., U.S., THE WOODLANDS, TEXAS, U.S., and AMSTERDAM, NETHERLANDS (23 August 2018) – Agendia, Inc., a world leader in precision oncology, announced today that US Oncology Research, one of the nation’s largest research networks dedicated to bringing cutting-edge treatment options to cancer patients and consisting of more than 150 research sites and over 1,000 investigators, has joined Agendia’s FLEX breast cancer registry study. FLEX is a large-scale, prospective, observational breast cancer study that links full genome profiling, including Agendia’s MammaPrint® risk of recurrence and BluePrint® molecular subtyping tests, with complete clinical data to create a comprehensive patient database with the potential to identify new gene associations with prognostic and/or predictive value in breast cancer.
The first milestone for the revolutionary database will be to capture full genomic and clinical data for 10,000 breast cancer patients and follow them over 10 years. Open to both women and men in the U.S. diagnosed with stage I, II, or III cancer, including all molecular sub-types, the dataset will be a true representation of the entire patient population. By capturing genomic and clinical data from all ethnicities, ages, genders, and from patients with co-morbidities, the FLEX database provides valuable opportunities to accelerate breast cancer research. It will also enable researchers to investigate the differences and trends between sub-groups and, importantly, to focus on smaller, more diverse, patient populations which have traditionally been challenging to recruit in sufficient numbers for clinical trials.
Since beginning enrollment in 2017, FLEX has 45 centers in the U.S. and has recruited over 700 patients. Under the terms of the agreement, all US Oncology Research-affiliated sites can participate in FLEX, with eight initial sites in Texas and Arizona already open for enrollment.
Dr. Joyce O’Shaughnessy, Chair of the Breast Cancer Program for US Oncology Research, Texas Oncology and Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Dallas, TX, said:
“FLEX has the potential to become one of the most valuable and impactful national datasets in breast cancer research – a veritable ‘Google’ for combined clinical and genomic breast cancer information. We are very pleased that our center is a part of this groundbreaking initiative. We look forward to giving patients the opportunity to help drive new discoveries in breast cancer by enabling their clinical information and full genome data from their tumor to be collected and added to the secure study database.”
Dr. William Audeh, Chief Medical Officer at Agendia, said:
“Big Data initiatives like FLEX in the U.S., and the PRECiSE trial running in parallel in the Netherlands, are a central part of our collective responsibility to deliver the benefits of precision oncology to patients with breast cancer. With every new cancer center and every new patient that participates in these studies, we are adding to a revolutionary dataset that investigators can interrogate to answer some of the big unanswered questions in breast cancer. The potential impact of access to gene expression data from approximately 20,000 genes matched with therapeutic interventions and long-term follow-up for 10,000 U.S. patients is invaluable to the cancer community.”
Agendia’s MammaPrint test analyzes 70 genes most associated with breast cancer recurrence to provide a clear, binary Low or High Risk of cancer recurrence result, while BluePrint analyzes 80 genes, which classify a patient’s breast cancer into functional molecular subtypes. Participants in FLEX will receive MammaPrint, with or without BluePrint testing. Full genome and comprehensive clinical data will be collected and added to the study database.
Click here to find out more about the FLEX study and how to participate.
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MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. The MammaPrint Blueprint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.
BluePrint is an 80-gene complementary laboratory-developed test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.
Agendia is a privately held, leading precision oncology company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, and the new MammaPrint BluePrint Recurrence and Molecular Subtyping test, on NGS technology.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology.
For more information on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.
About US Oncology Research
Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves approximately 60 research sites and more than 150 locations managing about 300 active trials at any given time. Physicians in the research network have enrolled more than 73,000 patients in over 1,600 trials since inception about two decades ago and have played a role in more than 75 FDA-approved cancer therapies, approximately one-third of all cancer therapies approved by the FDA to date. For more information visit www.usoncology.com/oncologists.
US Oncology Research