CA-AGENDIA
16.8.2024 12:01:34 CEST | Business Wire | Press release
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.
“We are very proud to receive the IVDR certification for our MammaPrint and BluePrint tests and look forward to continuing our efforts in providing accurate and effective test results to those undergoing breast cancer treatment,” said Mark R. Straley, Chief Executive Officer of Agendia. “This achievement not only underscores our commitment to delivering the highest standard of care to patients, but also highlights our ability to meet the stringent regulatory requirements necessary to address the needs of breast cancer patients and clinicians around the world.”
The IVDR certification marks a significant advancement in Agendia’s efforts to enhance the decision- making around treatment pathways for those with early breast cancer. For more information about the MammaPrint and BluePrint tests and Agendia’s ongoing clinical trials, please visit: www.agendia.com
About Agendia
Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint® + BluePrint®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment. Both assays have been approved for use in the clinical setting in the US and the EU.
Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer.
About MammaPrint
MammaPrint® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman’s risk of distant metastasis, MammaPrint provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories – ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life’s plans.
About BluePrint
BluePrint® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint measures the activity of 80 key genes that are involved in a tumor's growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman's tumor, BluePrint can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240816797768/en/
About Business Wire
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
IQM Secures €50M Financing to Accelerate Global Growth30.3.2026 08:00:00 CEST | Press release
€50 million financing package from funds and accounts managed by BlackRock will support IQM to scale operations, accelerate product development, and strengthen its market position. The facility will support acceleration of IQM’s technology roadmap, fuel R&D, support entry into additional markets, and advance IQM’s leadership in quantum computing as IQM prepares for public listing. IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), today announced it has secured a €50 millionfinancing package from funds and accounts managed by BlackRock. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329996942/en/ IQM Radiance quantum computer is located in IQM's showroom in Espoo, Finland. This facility will support acceleration of IQM’s technology roadmap, fuel R&D, support entry into additional markets, and advance IQM’s leadership in quantum computing. This
Bureau Veritas and Trade Technologies Join Forces to Streamline Global Trade Operations30.3.2026 07:45:00 CEST | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), through its Swiss branch Government Services Division, is pleased to announce a strategic agreement with Trade Technologies, the leading provider of trade finance automation, connectivity and transaction management services. This collaboration is a significant step toward reducing the complexities of international trade operations, particularly in regions where regulatory and inspection controls remain stringent. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260329411683/en/ Addressing Critical Trade Finance Challenges The agreement comes at a pivotal time for global trade. Letters of Credit (LCs) continue to serve as essential instruments in international commerce, particularly across the Middle East and Africa, where counterparty risk, foreign exchange controls, sanctions exposure, and regulatory oversight face ongoing challenges. In
Consortium Led by Axelspace Selected for Japan’s Space Strategy Fund Project “Technology to Enhance Capability of Next Generation Earth Observation Satellites”30.3.2026 01:35:00 CEST | Press release
~ Creating Climate Solutions and New Market Opportunities through Source-Specific CO2 Emission and Uptake Monitoring via Satellite Constellation and Aircraft ~ Axelspace Corporation, Meisei Electric Co., Ltd., ANA HOLDINGS INC., and JIJ Inc. are pleased to announce that their jointly proposed technology development project has been selected for Japan Aerospace Exploration Agency (JAXA)’s Space Strategy Fund under the theme “Technology to Enhance Capability of Next Generation Earth Observation Satellites.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323044518/en/ Conceptual Diagram of the project. Under this Space Strategy Fund initiative, spectrometers will be newly developed and demonstrated in orbit. In the future, the project envisions the establishment of a satellite constellation capable of observations at different times of the day. Project Summary (Planned) Technology Development Theme: Technology to Enhance Cap
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 20:00:00 CET | Press release
Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. Incyte (Nasdaq:INCY) to
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 20:00:00 CET | Press release
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 Safety profile consistent with Phase 2b studies with no new safety signals identified Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham,
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