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COMPANY:
Agendia

i
Other names: Agendia N.V. | Agendia, Inc. | Agendia Inc | Agendia | Agendia NV | Agendia Inc. USA
Related tests:
Evidence

News

3d
German Gynecological Oncology Group (AGO) recognizes BluePrint® in breast cancer guidelines (Businesswire)
"Agendia®, Inc...announced...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."
Clinical guideline
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BluePrint
26d
Agendia Announces New Data from I-SPY 2 Showcasing Ability of New Signature ImPrintTN to Predict Immunotherapy Response in Patients with Triple Negative Breast Cancer (Businesswire)
P2 | N=5,000 | I-SPY 2 (NCT01042379) | Sponsor: QuantumLeap Healthcare Collaborative | "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.... The study, examining the responses of patients who received a variety of IO regimens in the I-SPY 2 trial, showed that ImPrintTN predicts both response and non-response, suggesting that the test may help inform prioritization of IO versus other treatments for TN patients to best balance likely benefit versus the risk of the serious adverse effects that often accompany IO."
P2 data
1m
Agendia Presents Data at Miami Breast 2024 Demonstrating MammaPrint + BluePrint’s Ability to Further Stratify Tumor Categories in Hormone-Positive Breast Cancer, Highlighting Response to Different Chemotherapy Regimens (Businesswire)
P=Obs | N=25,000 | FLEX (NCT03053193) | Sponsor: Agendia | "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...The first poster....Results showed that patients with MP High 2 tumors, including Luminal B and Basal subtypes, are more likely to achieve a pCR in response to AC-T, while the addition of anthracycline to the therapy regimen does not appear to improve pCR rates for patients with MP High 1, Luminal B-type tumors."
Observational data
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MammaPrint • BluePrint
2ms
Agendia reports first patient enrolled in DEBRA Trial using MammaPrint (Agendia Press Release)
"Agendia®, Inc., announced...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."
Enrollment status
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MammaPrint
6ms
MammaPrint® approved for reimbursement in the Netherlands (Agendia Press Release)
"Agendia NV...announced...that the Dutch National Healthcare Institute (ZIN) has approved MammaPrint® for inclusion in the Dutch National health insurance basic package with immediate effect. Based on the MINDACT study data, ZIN affirmed that MammaPrint meets reimbursement criteria, paving the way for its inclusion. The reimbursement is applicable to women over 50 with hormone-positive, HER2-negative breast cancer and 0-3 lymph nodes involved (with clinical high risk). This significant decision, rendered by ZIN, represents a substantial step towards personalized care for women affected by breast cancer in the Netherlands."
Reimbursement
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MammaPrint
6ms
Agendia Collaborates with National Cancer Institute, SWOG Cancer Research Network for Phase III Trial; Led by University of Michigan's Dr. Erin Cobain (PRNewswire)
"Agendia, Inc...is collaborating with National Cancer Institute (NCI), part of the National institutes of Health and SWOG Cancer Research Network, funded by NCI, for a new clinical trial that will test the effectiveness of neoadjuvant immunotherapy for high-risk HR+ breast cancer patients...SWOG Trial S2206 (NCT06058377) is a prospective, randomized, Phase III trial focused on the application of immunotherapy in patients with MammaPrint High 2 Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Stage II-III Breast Cancer...Agendia's MammaPrint gene expression profiling test analyzes 70 genes associated with breast cancer recurrence and classifies patients with early-stage breast cancer as having a low or high risk of distant metastasis within four categories: UltraLow, Low, High 1, and High 2."
Trial status • Licensing / partnership
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MammaPrint
7ms
New neoadjuvant trial (mint) confirms the predictive utility of MammaPrint + BluePrint (Agendia Press Release)
"Agendia, Inc...announced...the publication of the Multi-Institutional Neoadjuvant Therapy MammaPrint Project I (MINT) trial, a prospective study designed to evaluate the utility of molecular profiling alongside traditional pathologic and clinical prognostic factors in predicting the response to neoadjuvant chemotherapy (NCT) in patients with locally advanced breast cancer (LABC)."
Clinical data
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MammaPrint • BluePrint
11ms
Agendia research shows highest risk MammaPrint® category predicts strongest chemosensitivity in women with early-stage HR+HER2- breast cancer (Agendia Press Release)
"At the 2023 ASCO Annual Meeting, Agendia, Inc...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."
Clinical data
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MammaPrint • BluePrint
11ms
Agendia studies reveal the influence of race on a tumor’s biology, reinforcing its commitment to advancing research of racial disparities in breast cancer (Agendia Press Release)
"At the 2023 ASCO Annual Meeting, Agendia, Inc...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...Agendia will also present a poster on MammaPrint’s ability to predict chemotherapy response in women with high-risk early-stage breast cancer, and an oral presentation on the ability of genomic biomarkers to predict a woman’s response to immunotherapy."
Clinical data
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MammaPrint • BluePrint
1year
Agendia Announces First Patient Enrolled in PROOFS Registry Trial to Determine Optimal Treatment and Ability to Forgo Chemotherapy for Premenopausal Women with Early HR+ Breast Cancer (Businesswire)
"Agendia...announced the first patient has been enrolled in the PROOFS Registry trial....The PROOFS Registry trial intends to enroll 1,500 patients via 100 sites in Germany by January 2025."
Trial status • Enrollment status
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MammaPrint
1year
Updated NCCN Guidelines Recognize MammaPrint UltraLow Risk Result, Highlighting its Clinical Utility for Women with Early-Stage Breast Cancer Who Can Safely Forgo Toxic Treatments with Excellent Survival Rates (Businesswire)
"Agendia, Inc...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."
NCCN guideline
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MammaPrint
over1year
Agendia level 1B evidence shows MammaPrint is the first and only FDA-cleared gene expression profiling test to predict benefit from extended endocrine therapy in early-stage breast cancer patients (Agendia Press Release)
"Agendia, Inc...announced it will present late-breaking research at the 2022 San Antonio Breast Cancer Symposium (SABCS) that proves MammaPrint is the first FDA-cleared gene expression profiling test to predict an early-stage breast cancer patient’s benefit from extended endocrine therapy (EET). The study, which analyzed MammaPrint results of over 500 patients enrolled in the IDEAL trial, proved MammaPrint test results can effectively identify which post-menopausal, hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients will benefit from five years of EET."
Clinical data
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MammaPrint
over1year
Level one evidence proves premenopausal patients within the ultra-low subset of Agendia’s MammaPrint low risk result can safely forgo chemotherapy (Agendia Press Release)
"At the 2022 San Antonio Breast Cancer Symposium (SABCS), Agendia, Inc...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...data suggests that many young women with early-stage breast cancer may safely avoid the toxicity of chemotherapy if treated appropriately with endocrine therapy."
Clinical data
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MammaPrint • BluePrint
over1year
Agendia spotlights the future of personalized breast cancer care at 2022 San Antonio Breast Cancer Symposium (Agendia Press Release)
"Agendia...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."
Real-world evidence • Retrospective data
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MammaPrint • BluePrint
over1year
Agendia announces first patient enrolled in prospective LESS clinical study, sponsored by Unicancer, to de-escalate endocrine therapy in women with early breast cancer (Agendia Press Release)
"Agendia, Inc...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."
Enrollment open
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MammaPrint
almost2years
Agendia presents data from the FLEX Real World Evidence Trial in seven posters at ASCO 2022, showcasing the power of its 30,000-patient breast cancer genome project (Agendia Press Release)
"Agendia, Inc...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."
Real-world evidence
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MammaPrint • BluePrint • Oncotype DX Breast Recurrence Score®Test
almost2years
Agendia Presents Data at ASCO 2022 Pointing to New Signature ImPrint Immunotherapy Prediction and Expansion of Proprietary Genomic Tests’ Utility to Identify Patients Who Will Benefit Most from Specific Treatments (Agendia Press Release)
"The goal was to migrate the I-SPY2 findings into a robust clinical-grade signature – a biomarker that had not previously existed in early stage breast cancer – to predict sensitivity to IO drugs that target PD-1/PDL-1, a cell pathway that, when overexpressed, allows many breast tumors to escape destruction by the immune system....Importantly, results showed that in the development phase, the gene-expression biomarker ImPrint met this task and had the potential to predict pathologic complete response (pCR) to PD-1/PDL-1 checkpoint inhibitors with high sensitivity and specificity, especially in ER+ breast cancer which represents a large population of women who may benefit."
Clinical data
almost2years
Agendia Achieves Historic Milestone of Enrolling 10,000 Patients in FLEX, the Largest-Ever Prospective, Real-World-Evidence Trial for Patients With Early Stage Breast Cancer (Agendia Press Release)
"Agendia...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....Six posters based on data from FLEX will be presented at ASCO 2022, one of which will be a poster discussion session."
Real-world evidence • Observational data • Enrollment status
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BluePrint
almost2years
Agendia to deliver robust suite of data advancing breast cancer care at ASCO 2022 (Businesswire)
"Agendia, Inc...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."
Clinical data
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MammaPrint • BluePrint
almost2years
Agendia Demonstrates Accessibility and Affordability of MammaPrint and BluePrint in Europe at ESMO Breast Cancer 2022 (Businesswire)
"The first of the two poster presentations, entitled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the next-generation sequencing (NGS) version of MammaPrint and BluePrint is equivalent to the centralized microarray test, as demonstrated by results from various labs globally. This enables a more accurate decentralized solution to breast cancer care fostering worldwide accessibility to more reliable genomic testing."
Clinical data
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MammaPrint • BluePrint
2years
Agendia study demonstrates MammaPrint® and BluePrint® capture full spectrum of early breast cancer biology, providing opportunity for highly individualized treatment (Agendia Press Release)
"Agendia, Inc...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."
Clinical data
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MammaPrint • BluePrint
over2years
Agendia to provide first digital MammaPrint capability to Brazil (Agendia Press Release)
"Agendia, Inc...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."
Clinical
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MammaPrint
over2years
Illumina partners with Agendia to expand genomic testing in breast cancer care (Illumina Press Release)
"Illumina, Inc...announced a multi-year partnership with Agendia N.V...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...Illumina and Agendia plan to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeq™Dx sequencing platform to expand the range of gene panels available for solid tumor analysis. We expect Agendia's flagship test, MammaPrint™, which is FDA-cleared and currently offered via Agendia's central laboratory, to be the first decentralized NGS-based breast cancer recurrence risk test cleared by the FDA."
Licensing / partnership
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MammaPrint
over2years
Agendia spotlight poster at SABCS 2021 confirms utility of BluePrint as biomarker subtyping test to guide neoadjuvant chemotherapy decisions (Agendia Press Release)
"Agendia, Inc...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."
Clinical data
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BluePrint
over2years
Agendia presents data at SABCS 2021 showing MammaPrint and BluePrint more robustly identify genomic differences in HR+ HER2- breast cancers in Black and White women beyond clinical factors (Agendia Press Release)
"Agendia, Inc...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)...The presentation, titled MammaPrint and BluePrint identify genomic differences in HR+ HER2- breast cancers from young Black and White women, highlights new data signaling that among young women (­<50 years of age) with localized hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, MammaPrint and BluePrint identified racial disparities in risk of recurrence and breast cancer subtype distribution not detected by existing clinical factors."
Clinical data
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MammaPrint • BluePrint
over2years
Analysis presented at SABCS 2021 confirms MammaPrint and BluePrint predict outcomes following neoadjuvant chemotherapy (Agendia Press Release)
"Agendia, Inc...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)."
Clinical data
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MammaPrint • BluePrint