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Agendia's genomic tests provides you with actionable insights throughout your patient’s breast cancer journey.

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Last post: Aug 14, 2026
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Site title: Agendia Precision Oncology - MammaPrint & BluePrint
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What Does a MammaPrint High Risk Result Mean?
Aug 14, 2026 · original
Every woman who receives a diagnosis of breast cancer is unique and requires a personalized treatment plan. An essential part of this plan is to understand the chance that breast cancer may have spread beyond the breast and could come back if not treated appropriately. The “risk” of this happening is different for every individual, and there are many pieces of information used to estimate this “risk of recurrence”. Because the goal of a personalized treatment plan is to reduce an individual’s risk of breast cancer recurrence, all available information, both clinical and genomic, is gathered to allow the physicians to make the best decisions. One term that may create confusion, and anxiety, is when a woman is told their early-stage breast cancer is “High Risk”. For hormone receptor-positive breast cancer, this means that hormone therapy alone may not sufficiently reduce the risk of recurr
Cancer Diagnostics Are Expanding As New Approaches Provide a Broader View of Tumor Biology and Disease Progression
Aug 11, 2026 · original
For years, a cancer diagnosis often came down to one test, one gene, one mutation. Today, clinical laboratories are adopting broader approaches—including whole-genome sequencing, functional RNA profiling, liquid biopsy , and multi-omic testing—that provide more comprehensive molecular information and help clinicians monitor disease over time, expanding what they can learn from a tumor and how that information guides patient care. “We are moving well beyond the traditional approach of testing a single mutation in a single gene,” says Luca Quagliata, PhD, corporate head of diagnostic medical and scientific affairs for the products and technology sector at Thermo Fisher Scientific. Laboratories can now analyze multiple layers of disease biology, including DNA-level alterations such as mutations and methylation patterns, as well as RNA-level changes involving gene fusions, structural variant
Agendia Announces Definitive, Mandatory Swiss Health Insurance Reimbursement for MammaPrint
Jul 14, 2026 · original
Effective 1 July 2026 , Switzerland’s FOPH completes its review of multigene expression testing, formally deciding to continue reimbursement indefinitely IRVINE, Calif, and AMSTERDAM — July 14, 2026 — Agendia®, Inc., a leader in precision oncology for breast cancer, today announced the official ruling by the Swiss Federal Office of Public Health (FOPH) to grant definitive, mandatory health insurance (Obligatorische Krankenpflegeversicherung, or OKP) coverage for multigene expression tests, including MammaPrint® for eligible patients with early-stage breast cancer. The tests are intended to help guide chemotherapy decision-making and have been covered by insurance since 1 January 2015, subject to evaluation. Effective 1 July 2026, this regulatory update successfully concludes a provisional evaluation framework establishing the diagnostics as a mandatory insurance obligation in the Swiss h
Core Needle Biopsy and Genomic Testing in Breast Cancer
Jun 30, 2026 · original
Hearing the words “you need a biopsy” or “we found something suspicious” during a clinical breast exam, mammogram, or MRI can stop everything in its tracks. Feeling worried or uncertain in that moment is completely natural. One of the first steps toward clarity is the core needle biopsy —a minimally invasive procedure that provides crucial information about what is happening inside the breast. Although it may seem like a routine diagnostic procedure, a core needle biopsy holds powerful information that can provide the earliest, most meaningful insights into the biology of a tumor—information that can guide your treatment from the very beginning. Behind every biopsy is a person, and behind every genomic test — MammaPrint® and BluePrint® —is a more personalized path to care. What the Biopsy Procedure Entails A core needle biopsy uses a thin, hollow needle to remove small samples of breast
Genomic Profiling with MammaPrint + BluePrint Predicts Anthracycline Chemotherapy Benefit and Guides Personalized Treatment Selection in HR+HER2- Early-Stage Breast Cancer
Jun 25, 2026 · original
FLEX Study data shows that patients with MammaPrint High Risk 2 tumors have improved 3-year survival with anthracycline-containing regimens, while patients with High Risk 1 tumors show no additional benefit IRVINE, Calif, and AMSTERDAM — June 25, 2026 — Agendia®, Inc., a leader in precision oncology for breast cancer, today announced the publication of a new paper in JCO Precision Oncology, titled “Prediction of Anthracycline Benefit in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Early-Stage Breast Cancer by the MammaPrint 70-Gene Signature for Patients Enrolled in the FLEX Study.” The study, based on data from the prospective, real-world FLEX Study ( NCT03053193 ), found that MammaPrint ® + BluePrint ® can help identify a subset of patients with hormone receptor positive, HER2-negative (HR+HER2-) early-stage breast cancer (EBC) most likely to benefit fro
Prediction of Anthracycline Benefit in Hormone Receptor– Positive, Human Epidermal Growth Factor Receptor 2– Negative Early-Stage Breast Cancer by the MammaPrint 70-Gene Signature for Patients Enrolled in the FLEX Study
Jun 23, 2026 · original
Publication: JCO Precis Oncol, June 2026 DOI https://doi.org/10.1200/PO-25-01285 Authors: Joyce O’Shaughnessy et al. Title: Prognostic Performance of MammaPrint in Patients with Small T1a, b, and c Node-Negative Early Breast Cancer Abstract Purpose: Randomized trials have not demonstrated clear benefit from anthracyclines for patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HER22) early breast cancer (EBC). The MammaPrint 70- gene signature, specifically the High-Risk 1 (H1) and High-Risk 2 (H2) subgroups, was evaluated in predicting benefit from anthracycline- and taxane based chemotherapy (AC-T) compared with taxane/cyclophosphamide (TC) in hormone receptor–positive HER22 EBC. Materials & Methods: This analysis used prospectively collected real-world data from patients enrolled in the FLEX study with stage I-III hormone receptor–positive HER22
ASCO 2026: Genomics Reveal HRD–Treatment Response Link
Jun 8, 2026 · original
Gene expression profiling links HRD in patients with high risk breast cancer with anthracycline outcomes Steven Isakoff, Breast Medical Oncologist at Mass General Brigham Cancer Institute, shares findings from a 70-gene signature breast cancer study, presented at ASCO 2026. The study assessed the relationship between homologous recombination deficiency and breast cancer risk category determined with the 70-gene assay. The following transcript has been edited for clarity. My name is Steven Isakoff. I’m a breast medical oncologist at Mass General Brigham Cancer Institute, and we’re here at ASCO 2026 in the poster session. Today, I’m presenting a poster looking at the seventy-gene signature to see if we can identify a correlation between homologous recombination deficiency and the different outcomes between high risk 1, high risk 2, low risk, and ultra low risk. The data that we looked at s
Integration of molecular subtyping and immune profiling to predict pathologic complete response in HER2+ breast cancer treated with neoadjuvant dual HER2 therapy
Jun 1, 2026 · original
Publication: ASCO 2026, Abstract #621 Authors: David Page Title: Prognostic Performance of MammaPrint in Patients with Small T1a, b, and c Node-Negative Early Breast Cancer Abstract Background: Neoadjuvant outcomes are variable in human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (EBC), highlighting the unmet need for predictive biomarkers. The BluePrint (BP) assay classifies tumors by molecular intrinsic subtype, whereas the ImPrint hormone receptor-positive (HR+) and ImPrint triple-negative genomic signatures predicted immune sensitivity in the ISPY2 trial. Because HER2+ EBCs are genomically heterogeneous, and because anti-HER2 has an immunologic mechanism of action, we hypothesized that BP and ImPrint could be used to predict outcomes (pathologic complete response, pCR) following neoadjuvant chemotherapy + anti-HER2 (trastuzumab + pertuzumab, HP). Methods:
Association of the 70-gene assay and homologous recombination deficiency in patients with High Risk 2 breast cancers
Jun 1, 2026 · original
Publication: ASCO 2026, Abstract #561 Authors: Steve Isakoff Title: Association of the 70-gene assay and homologous recombination deficiency in patients with High Risk 2 breast cancers Abstract Background: Homologous recombination deficiency (HRD) is a biomarker for impaired DNA repair proficiency and genomic instability, associated with sensitivity to DNA-damaging agents. MammaPrint (MP), a 70-gene assay, stratifies early breast cancer (EBC) by UltraLow, Low, High Risk 1 (H1) or High Risk 2 (H2) of recurrence. Compared to patients (pts) with H1 tumors, pts with H2 tumors derive greater benefit from anthracycline-based chemotherapy. Here we analyze HRD signatures to assess whether MP gene expression profiling may detect pathway activity in H2 tumors indicating DNA repair deficiency. Methods: We analyzed tumors from pts enrolled in the FLEX study who consented to full transcriptome and cl
Agendia to Present New FLEX Study Data at ASCO 2026 Supporting NCCN Clinical Practice Guidelines in Oncology Update Recognizing MammaPrint for Guiding Anthracycline Use in Early-Stage Breast Cancer
May 21, 2026 · original
Additional research highlights integration of BluePrint molecular subtyping and ImPrint immune profiling to optimize prediction of neoadjuvant treatment response in HER2-positive early-stage breast cancer IRVINE, Calif, and AMSTERDAM — May 21, 2026 — 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). Poster #46 | June 1, 1:30 p.m. – 4:30 p.m. CDT | Presenter: Steven Isakoff Association of the 70-gene assay and homologous recombination deficiency in patients with High Risk 2

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