Articles from Agendia, Inc.

Agendia®, Inc., a leader in precision oncology for breast cancer, today announced new data to be presented at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 29 – June 2 in Chicago. The company will present two posters highlighting how MammaPrint® (MP) + BluePrint® (BP) provide biological insights into treatment response and help further refine therapeutic decision-making for patients with early-stage breast cancer (EBC).

Agendia, Inc., a leader in precision oncology for breast cancer, today announced the publication of a new study in npj Breast Cancer, titled "Identification of racial disparities across MammaPrint and BluePrint subtypes in HR+HER2– breast cancer.”

Agendia, Inc., a leader in innovative genomic testing for breast cancer, today announced the publication of new findings in JNCI Cancer Spectrum validating the predictive utility of the MammaPrint 70-gene assay for chemotherapy benefit in patients with hormone receptor-positive, HER2-negative (HR+HER2-) early-stage breast cancer. The peer-reviewed article, titled "MammaPrint Predicts Chemotherapy Benefit in HR+HER2- Early Breast Cancer: FLEX Registry Real-World Data," highlights how the MammaPrint Index predicts benefit from chemotherapy using a real-world, prospective, observational dataset.

Agendia®, Inc., a leader in precision oncology for breast cancer, today announced the presentation of four major abstracts in collaboration with independent investigators at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 29th- June 3rd, 2025, in Chicago, Illinois.

Agendia®, Inc., announced today that new data on its comprehensive genomic tests will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO), taking place May 30th – June 3rd, 2025, in Chicago, Illinois.

Agendia®, Inc., announced today that new MammaPrint and BluePrint data and their ability to inform axillary surgery decisions in the neoadjuvant setting will be presented at the 26th American Society of Breast Surgeons Annual Meeting (ASBrS), taking place in Las Vegas, NV, April 30 – May 4, 2025.

Agendia®, Inc. today provided a topline review of the company’s key milestone achievements in 2024. These updates include significant inroads in expanding market access, product innovation, commercial growth, advancements in research, as well as key partnerships and awards.

Agendia®, Inc., today announced it will be presenting new data from the Real-World Data Registry, FLEX, demonstrating MammaPrint®’s ability to predict chemotherapy benefit in patients with HR+HER2- early-stage breast cancer. The findings will be presented at the San Antonio Breast Cancer Symposium 2024 (SABCS), on Wednesday, December 11th.

Agendia®, Inc. today announced the publication of a pivotal secondary analysis from the IDEAL randomized Phase 3 clinical trial in JAMA Network Open. The study highlights the ability of the MammaPrint (MP) genomic assay to predict benefit of extended endocrine therapy (EET) in post-menopausal patients with early-stage, hormone receptor positive (HR+) breast cancer.

Agendia®, Inc., announced today that new data on its early-stage breast cancer genomic tests and their ability to inform treatment selection decisions will be presented at the San Antonio Breast Cancer Symposium 2024 (SABCS), taking place in San Antonio, TX, December 10th – 13th, 2024.

Prof. Dr. Laura van 't Veer, co-founder of Agendia, pioneer in personalized cancer care and co-developer of the MammaPrint® genomic breast cancer recurrence test, will be honored in November and December at three prestigious breast cancer symposia in Italy, the Netherlands and the U.S. for her pioneering work in molecular cancer diagnostics and breast cancer research over the past 30 years.

Agendia, Inc. today announced that a diverse patient population of over 17,000 has been successfully enrolled in the FLEX Study, a prospective real-world evidence, whole transcriptome, observational breast cancer study (NCT03053193). The FLEX Study, which intends to enroll 30,000 patients, employs a patient-centric design to accelerate impactful data generation through a national network of participating sites. This approach encourages investigator-initiated sub-studies, providing robust analysis of diverse patient populations and supporting various research perspectives that, as a result, enhances the scope of the overall study.

Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint® and BluePrint® NGS Kit. These products are classified as Class C under this regulation. This certification recognizes Agendia’s strict adherence to rigorous quality and safety standards and ensures the tests’ reliability and effectiveness in clinical settings across the EU.

Agendia®, Inc. today announced that the NSABP B-42 study evaluating the MammaPrint assay in predicting the benefit of extended endocrine therapy (EET) in early-stage breast cancer patients was published in the July issue of Journal of Clinical Oncology.

Agendia®, Inc. today announced it will present new data on the 3-year outcome of patients with hormone receptor-positive (HR+), HER2-negative early-stage breast cancer when treated with two different chemotherapy regimens at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on May 31st, 2024.

Agendia®, Inc. announced today that the company’s 80-gene molecular subtyping assay, BluePrint®, is now included in the latest version of German Gynecological Oncology Group (AGO) guidelines. The assay was added to the list of predictive factors for neoadjuvant chemotherapy decision making.

Agendia®, Inc. today announced new data from the I-SPY 2 trial showcasing its ImPrint signature for patients with triple negative (TN) breast cancer, shared by I-SPY 2 researchers in an oral presentation at the 14th European Breast Cancer Conference in Milan, Italy. Agendia has been in partnership with Quantum Leap Healthcare Collaborative, the sponsors of the neoadjuvant biomarker-rich I-SPY 2 trial, since 2010. I-SPY 2 established a new benchmark for the efficacy of Phase 2 clinical trials and is widely regarded as the pioneer of the platform trial.

Agendia®, Inc., announced today it will share new data from the ongoing prospective, observational FLEX Trial (NCT03053193) in two poster presentations at the 41st Annual Miami Breast Cancer Conference (MBCC), taking place March 7 – 10th, 2024.

Agendia®, Inc., announced today that the first patient to use MammaPrint® as an enrollment biomarker for the DEBRA Trial is to be enrolled. The Phase III NRG Oncology De-Escalation of Breast Radiation (DEBRA) Trial (NCT04852887) is a clinical study looking at safely reducing the use of breast radiation after lumpectomy for people with low-risk, early-stage breast cancer.

Agendia, Inc., a gene expression profiling company advancing personalized early-stage breast cancer care, today announced the appointment of industry veterans Ronald (Ron) Andrews and David Schreiber to the company’s Board of Directors.

At the 2023 ASCO Annual Meeting, Agendia, Inc., a gene expression profiling company advancing personalized early-stage breast cancer care, reinforces its commitment to progressing research of racial disparities in breast cancer through two poster presentations. Building off the research presented at the 2022 annual meeting, which found that BluePrint identifies stark racial disparities among women with HR+HER2- tumors [1], the data presented at this year’s meeting examines the impact of race on the underlying biology of HER2+ tumors. This data, in addition to substantial growth in enrollment in Agendia’s FLEX trial, demonstrates the importance of understanding how race influences a tumor’s gene expression to inform personalized, biology-based breast cancer care for patients of all racial and ethnic backgrounds.

At the 2023 ASCO Annual Meeting, Agendia, Inc., a gene expression profiling company advancing personalized early-stage breast cancer care, will present data that proves MammaPrint can predict chemotherapy sensitivity in women with early-stage, HR+HER- breast cancer. The research examined the clinical utility of MammaPrint’s two High Risk subcategories, High 1 (H1) and High 2 (H2), as an indicator of a woman’s predicted response to chemotherapy and five-year outcomes, in combination with BluePrint’s® molecular subtyping, to guide treatment decisions. The study found that women with H2 risk tumors are more likely to respond to chemotherapy and have aggressive, Basal-type tumors compared to women with H1 risk tumors. This data highlights the critical role MammaPrint and BluePrint play in identifying women with the highest risk tumors as early as possible to optimize and personalize treatment planning and improve their chance of survival.

Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, today announced the first patient has been enrolled in the PROOFS Registry trial. In partnership with the West German Study Group (WSG), the study aims to determine whether premenopausal women with early HR+ breast cancer, originally defined as clinically high-risk and classified as MammaPrint Low Risk, can avoid chemotherapy, and maintain strong outcomes by opting instead for temporary ovarian function suppression (OFS) in combination with endocrine therapy. By determining the drivers behind a young woman’s response to chemotherapy, the trial’s results could empower young women with the ability to safely forgo chemotherapy toxicities and preserve their fertility and quality of life.

Agendia, Inc., a leader in breast cancer gene expression profiling, today announced the updated National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology – Breast Cancer Version 1.2023, recognize Agendia’s MammaPrint UltraLow Risk result and its proven impact on patient care. This inclusion is particularly critical for women with early-stage breast cancer who receive an UltraLow Risk test result and can safely forgo toxic treatments yet maintain excellent chance of survival. The NCCN’s recognition of this risk category will enable clinicians to confidently identify which tumors have an exceedingly low risk of distant metastasis, ultimately empowering them and their patients to determine the best possible path towards a cure while minimizing unnecessary treatment.

At the 2022 San Antonio Breast Cancer Symposium (SABCS), Agendia, Inc., a leader in breast cancer gene expression profiling, will present data demonstrating its proprietary signatures fulfill a critical unmet need for precise, proactive treatment planning for premenopausal women with early-stage breast cancer. As part of this presentation, Dr. William Audeh, Chief Medical Officer of Agendia, will include new data in the Journal of Clinical Oncology that was not available at the time current guidelines were drafted. This data suggests that many young women with early-stage breast cancer may safely avoid the toxicity of chemotherapy if treated appropriately with endocrine therapy.

Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, received acceptance for all six abstract submissions that will help guide the future of personalized cancer care and will be presented at the 2022 San Antonio Breast Cancer Symposium (SABCS). These studies focus on the impact of MammaPrint and BluePrint test results, unveiling the underlying biology of a breast cancer patient’s unique tumor to help inform more personalized treatment decisions. The data reaffirm Agendia’s commitment to driving the science behind early-stage breast cancer, so women and their providers have access to an accurate assessment of the tumor’s risk of metastasizing, and of which molecular pathway is driving that tumor’s growth. These informative insights come from Agendia’s proprietary signature derived directly from the tumor’s biology and go beyond conventional methods.

Agendia, Inc., a commercial-stage company focused on assessing an individual tumor’s risk of metastasis and the molecular subtyping reasons for its growth, today announced the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia. In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study aims to enroll 696 patients via 45 sites within the French breast cancer intergroup Unicancer (UCBG) by October 2024.

Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will present seven posters derived from the company’s FLEX Trial, the real-world, multicenter, prospective, observational breast cancer study at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will share findings in a poster discussion debuting initial data from its ImPrint test, a 53-gene signature in development, at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced 10,000 patients have been successfully enrolled in the FLEX Registry. Agendia’s unique FLEX Registry is a real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer.

Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, today announced that it will present new data at the European Society for Medical Oncology (ESMO) Breast Cancer Congress 2022 taking place in Berlin, Germany on May 3-5, 2022.

Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, today announced it will present new data from ongoing clinical research evaluating its comprehensive genomic tests at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place June 3-7, 2022 in Chicago, Illinois.

Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, today announced the appointment of global commercial leader Elizabeth (Betsy) Hanna as Executive Vice President and Chief Commercial Officer, effective March 15, 2022.

Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, today announced new data published in Genes, Chromosomes and Cancer (Genes) that show MammaPrint® and BluePrint® gene signatures represent and capture all of the original 10 hallmarks of cancer (HoCs), recognized as the biological capabilities acquired during the multi-step development of human cancer, as defined by Hanahan and Weinberg.1,2

Agendia, Inc., a commercial stage company focused on precision oncology for breast cancer, today announced that it is offering early access to its Digital MammaPrint platform for patients with breast cancer in Brazil, expanding the company’s offerings in the country with the goal of bringing essential information from cancer testing to the larger global breast cancer community. Brazil is the first country to have samples analyzed by Digital MammaPrint, allowing physicians and their patients to benefit from genomic insights derived from a digitized image of a breast cancer tumor. Results about individual tumors will now be informed by the new artificial intelligence (AI) platform, also providing better turnaround time for their treatment decisions.

Agendia, Inc., a commercial stage company focused on precision oncology for breast cancer, today announced a multi-year partnership with Illumina, Inc. (NASDAQ: ILMN), to co-develop in vitro diagnostic (IVD) tests for oncology testing. The partnership is intended to advance the use of next-generation sequencing (NGS) for decentralized oncology testing and aligns with Illumina’s approach to IVD partnerships in oncology. Agendia joins Illumina’s growing portfolio of more than 30 IVD partners developing over 40 sequencing-based solutions for cancer prognosis, therapy selection, and other applications.

Agendia, Inc., a commercial stage company focused on precision oncology for breast cancer, today announced the appointment of healthcare industry veterans Suja Chandrasekaran, MS and Scott Mendel, MBA to the Company’s Board of Directors.

Agendia, Inc., a world leader in precision oncology for breast cancer, announced that it will present a spotlight poster at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021) which confirms the utility of BluePrint® in guiding neoadjuvant treatment decisions.

Agendia, Inc., a world leader in precision oncology for breast cancer, today shared data demonstrating the ability of MammaPrint® and BluePrint® to predict patient outcomes following neoadjuvant chemotherapy (NAC) at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021).

Agendia, Inc., a world leader in precision oncology for breast cancer, today presented data from a research collaboration with Vanderbilt University Medical Center demonstrating the capability of MammaPrint® and BluePrint® to identify differences in recurrence risk and tumor classification amongst different racial groups at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021).

Agendia, Inc., a world leader in precision oncology for breast cancer, today announced positive results from an analysis using its 70-gene MammaPrint® assay on samples from the NSABP B-42 trial. These results were reported as an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Agendia, Inc., a world leader in precision oncology for breast cancer, today announced that data from the landmark MINDACT study will be shared at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting in an oral presentation. The presentation will detail an additional risk threshold previously established within the MammaPrint Low Risk category, identifying patients with an Ultra Low Risk of distant recurrence, essentially meaning the patient’s tumor is very unlikely to recur or metastasize over at least 20 years of follow-up, according to prior studies. This information could be helpful in further tailoring adjuvant treatment for patients with early stage breast cancer.

Agendia, Inc., a world leader in precision oncology for breast cancer, announced that new data from the first-of-its kind, national FLEX registry was debuted today at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Agendia, Inc., a world leader in precision oncology for breast cancer, announced today that an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting revealed new data from the national FLEX registry that identify differences in tumor biology between ethnic groups that can lead to meaningful treatment decisions, reinforcing the need for appropriate representation of diverse patient populations in breast cancer studies.