NCCN更新治疗指引，将MammaPrint纳入乳癌检测1级美国国家癌症资讯网(NCCN)和美国临床肿瘤医学会(ASCO)针对lymph-node positive患者，更新的NCCN治疗指引中推荐的唯一基因组乳癌检测工具美国国家癌症资讯网(NCCN)更新治疗指引，将MammaPrint纳入乳癌检测1级NCCN推荐Agendia的MammaPrint为高水平的乳癌检测，对於早期乳癌患者ER+，lymph-node negative和lymph-node positive（LN+1-3）MammaPrint现在是美国国家癌症资讯网(NCCN)和美国临床肿瘤医学会(ASCO)针对lymph-node positive患者，更新的NCCN治疗指引中推荐的唯一基因组乳癌检测工具。Agendia的公司今天宣布，美国国家癌症资讯网(NCCN)更新了其临床实践治疗指引为包括MammaPrint 70-基因乳癌复发风险测试，有助於确定乳癌在lymph-node negative或positive(LN + 1-3)的ER+乳癌患者中复发的可能性。通过这些更新，MammaPrint获得了基因组测试的最广泛指导，具并且是同类测试中唯一具有1级的lymph-node negative和lymph-node positive疾病证据的检测。NCCN美国国家癌症资讯网(National Comprehensive Cancer Network)治疗指引是公认的癌症治疗临床标准，是由领先的癌症中心的临床医生和研究人员提供的。NCCN根据现有证据修订推荐的实践治疗指引，最终目标是改善患者护理和结果。MammaPrint纳入NCCN治疗指引是基於具有里程碑意义的临床试验MINDACT的数据，这是一项随机，前瞻性的III期试验，评估了MammaPrint试验的临床效用。该研究於2016年发表在“ New England Journal of Medicine”上，发现近50％的患者最初根据临床和病理因素确定其癌症复发风险高，因此而接受化疗的患者实际上是低风险的。MammaPrint分析了与乳癌复发相关的70个最关键的基因，将每个乳癌患者分类为诊断后早期10年内发生转移的“低风险”或“高风险”。您可以访问www.nccn.org查看NCCN更新的治疗指引。Agendia Announces Level 1 Inclusion of MammaPrint® Breast Cancer Test in Updated National Comprehensive Cancer Network® (NCCN) GuidelinesAgendia Announces Level 1 Inclusion of MammaPrint® Breast Cancer Test in Updated National Comprehensive Cancer Network® (NCCN) GuidelinesThe NCCN recommends Agendia’s MammaPrint® breast cancer test with the highest level of evidence for early-stage breast cancer patients with estrogen receptor-positive, lymph-node negative and lymph-node positive (LN+ 1-3) MammaPrint is now the only genomic breast cancer test that is recommended in guidelines by the NCCN and the American Society of Clinical Oncology (ASCO) for lymph-node positive patients The updated NCCN Guidelines – released during Breast Cancer Awareness Month– mark the fifth positive international guideline update for MammaPrint since 2017IRVINE, CALIF., U.S., AMSTERDAM, NETHERLANDS – 9 October 2018 – Agendia, Inc., a world leader in precision oncology, today announced that the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include the MammaPrint® 70-gene Breast Cancer Risk-of-Recurrence Test, which helps determine the likelihood breast cancer will recur in patients with estrogen receptor-positive breast cancer that is either lymph-node negative or positive (LN+ 1-3). With these updates, MammaPrint has received the broadest guidance of any genomic test, and is the only test of its kind with Level 1 evidence for both lymph-node negative and lymph-node positive disease.The NCCN Guidelines, which are the recognized clinical standard for cancer care, are created by input from clinicians and researchers at leading cancer centers. The NCCN revises recommended practice guidelines according to current evidence with the ultimate goal of improving patient care and outcomes.MammaPrint’s inclusion in the NCCN guidelines is based on data from the landmark clinical trial, MINDACT, a randomized, prospective, Phase III trial, which evaluated the clinical utility of the MammaPrint test. The study, published in the New England Journal of Medicine in 2016, found that almost 50 percent of patients initially identified with a high risk of their cancer recurring based on clinical and pathological factors and thus candidates for chemotherapy, were in fact Low Risk according to the MammaPrint test and unlikely to benefit from it.MammaPrint analyzes the 70 most important genes associated with breast cancer recurrence to classify each breast cancer patient into “Low Risk” or “High Risk” of developing metastases within the first 10 years after diagnosis.You can access the updated NCCN guidelines at www.nccn.org.http://www.ybe.com.tw/hot_293657.htmlNCCN更新治疗指引，将MammaPrint纳入乳癌检测1级 │ 美国国家癌症资讯网(NCCN)和美国临床肿瘤医学会(ASCO)针对lymph-node positive患者，更新的NCCN治疗指引中推荐的唯一基因组乳癌检测工具2022-09-062023-09-06
MammaPrint+BluePrint欣扶你乳癌肿瘤基因双效检测被专家们列入美国NCCN治疗指引美国NCCN guidelines内容摘录： 乳癌患者可以"predictions of clinical outcome"ER-positive及ER-negative乳癌患者可以"predictions of clinical outcome" MammaPrint is approved by the FDA to assist in assignment of women with ER-positive or ER-negative breast cancer into a high versus low risk for recurrence.MammaPrint is listed as "New Treatment Implications" in NCCN Guidelines:With a median follow-up of 5 years, among patients at high clinical risk and low genomic risk,the rate of survival without distant metastasis in this group was 94.7% among those not receiving chemotherapy.Among patients with 1-3 positive nodes,the rates of survival without distant metastases were 96.3% in the chemotherapy group and 95.6% in the no-chemotherapy group.Therefore, the benefit of chemotherapy may be smaill in this group.关於NCCN http://www.ybe.com.tw/hot_96546.html列入美国NCCN治疗指引 │ 美国NCCN guidelines内容摘录：乳癌患者可以"predictions of clinical outcome"2022-09-062023-09-06
MammaPrint+BluePrint欣扶你乳癌肿瘤基因双效检测获得2013圣加伦S't Gallen Consensus国际乳癌专家会议共识乳癌专家：未来两年内早期乳癌治疗一致共识。圣加仑St.Gallen肿瘤学会议是全球专家研讨有关早期乳癌临床治疗的专业会议，全球共有95个国家3,700个成员参加，其中有来自21个国家51个国际的乳癌专家成员来拟定对治疗的建议。在2013年3月在瑞士圣加伦举行第13届国际乳癌专家会议，经过讨论后以投票的方式形成专家对乳癌手术，贺尔蒙治疗，放射性治疗，化学治疗，分子诊断亚型等多个方面的具体问题达成未来两年内早期乳癌治疗一致共识。关於圣加仑St.Gallen肿瘤学会议about the foundation St.Gallen Oncology Conferences (SONK)St.Gallen Oncology Conferences (SONK) is a private charitable and tax-exempted educational foundation according to Swiss law, registered and supervised by the Department of Interiors of the Swiss Canton (State) of St.Gallen in Eastern Switzerland.St.Gallen Oncology Conferences (SONK) consists of two different programs:The international conference part in English language, organizes since 1978 repeatedly international breast cancer conferences (Primary Therapy of Early Breast Cancer) including the highly respected, now biannually, international breast cancer treatment consensus recommendations since 1978/82 as well as repeated international conferences on “Clinical Cancer Prevention” since 1998 and also international symposia about other topics.The coordination secretariat of the Deutschsprachig-Europäische Schule für Onkologie (deso), an educational program for oncologists and oncology nurses in German.St.Gallen Oncology ConferencesSt.Gallen Oncology Conferences SONK is organising international conferences. The events deal withbreast cancergastrointestal cancerclinical cancer prevention and geneticscancer patients care issues (nursing oncology, supportive care, psycho-oncology).The congresses have built up a high impact in the international medical world over the past 20 years. Especially the consensus meeting about early breast cancer therapies influences treatments globally.Presentations and abstracts of the meetings are published world wide in renowned medical journals.The first breast cancer conference organised by St.Gallen Oncology Conferences was held 1978. SONK has been legally founded 1996 as a charitable foundation in order to provide a stable organisational framework for the events. The foundations' aim is to promote knowledge and exchange of experiences within the medical community in order to increase a high quality of treatment for cancer patients worldwide. Initiator of SONK is Prof. Hans-Jörg Senn MD, who has created and built up the organisation.http://www.ybe.com.tw/hot_94744.html获得2013圣加伦S't Gallen Consensus国际乳癌专家会议共识 │ 乳癌专家：未来两年内早期乳癌治疗一致共识。2022-09-062023-09-06
MammaPrint+BluePrint欣扶你乳癌肿瘤基因双效检测列入ASCO美国临床肿瘤学会《临床实践指南》ASCO(American Society of Clinical Oncology)美国临床肿瘤学会於2017年7月10日，在《临床实践指南》发表了题为“Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer”使用生物标志对早期浸润性乳癌妇女的全身性辅助治疗决策指引，再次肯定了MINDACT试验的临床应用价值，您可经由下列ASCO网站连结一睹最新聚焦亮点：ASCO(American Society of Clinical Oncology)美国临床肿瘤学会发表：https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9746JCO(Journal of clinical oncology)临床肿瘤学杂志亦同步发表：http://ascopubs.org/doi/full/10.1200/JCO.2017.74.0472ASCO推荐ER/PgR–positive, HER2-negative, node-negative, or one to three positive nodes临床高危险群病患，使用MammaPrint可进行化疗必要性之决定。其中针对one to three positive nodes病患群，可谓是MINDACT带来的患者福音，也是唯一ASCO推荐之高水准MammaPrint基因组测试。http://www.ybe.com.tw/hot_239541.html列入ASCO《临床实践指南》│ ASCO临床实践指南发表了题为“Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer”使用生物标志对早期浸润性乳癌妇女的全身性辅助治疗决策指引2022-09-062023-09-06
获得美国NIH国家卫生研究院肯定临床试验I-SPY 2：筛选乳癌患者进入乳癌新药研发临床试验的唯一乳癌肿瘤基因分析的检测工具。美国FDA和美国国家卫生研究院(National Institutes of Health,NIH)倾力赞助的乳癌新药研发之临床试验I-SPY 2，致力於加速乳癌新药「个人化治疗」的开发平台，以MammaPrint+BluePrint 欣扶你乳癌肿瘤基因双效检测做为筛选乳癌患者进入乳癌新药研发临床试验的唯一乳癌肿瘤基因分析的检测工具。 I-SPY 2:Investigation of Serial Studies to Predict Your Therapeutic Response with lmaging and Moleculalysishttp://www.ybe.com.tw/hot_86139.html获得美国NIH国家卫生研究院肯定 │ 临床试验I-SPY 2：筛选乳癌患者进入乳癌新药研发临床试验的唯一乳癌肿瘤基因分析的检测工具。2022-09-062023-09-06
MammaPrint+BluePrint欣扶你乳癌肿瘤基因双效检测Agendia获得MammaPrint乳癌复发检测和BluePrint分子亚型检测的CE标志MammaPrint + BluePrint Kit现已获得CE认证，使公司能够在欧洲将该设备商业化。Agendia EMEA商务副总裁Marjolaine Baldo博士说：“获得MammaPrint和BluePrint Kit的CE标志是一个重要的里程碑。欧洲著名的癌症中心将首次使用现有的NGS仪器在自己的实验室中运行MammaPrint和BluePrint。因此，患者将能够更好地获得这些重要测试以及为她们个人化乳癌管理带来的显著益处。“为我们团队、合作伙伴和共同验证中心的努力得到激励，对於奉献精神和专业知识感到自豪，他们需要分工协力的解决方案，不知疲倦地开发、验证并将这一重要设备推向市场。我们期待与领先的乳癌中心合作，为他们提供这些工具，使他们能够在内部设立并提供乳癌复发风险测试。MammaPrint分析了70个与乳癌复发最相关的基因，以提供低或高风险的癌症复发结果，而BluePrint分析80个基因，将患者的乳癌分子亚型分析。这种新设备结合了MammaPrint和BluePrint，可以帮助医生为患者提供个人化的治疗管理决策，通过识别患有早期乳癌的女性，她们在五年内基因组处於低或高风险的远处转移。MammaPrint和BluePrint Kit是Agendia现有的MammaPrint和BluePrint测试的基於RNA测序的版本，目前在通过CLIA和CAP认证位在加利福尼亚州欧文和荷兰阿姆斯特丹的Agendia实验室集中进行。该试剂盒是与Agilent Technologies合作开发的，使用他们的SureSelect靶向富集系统和Bluebee，后者为临床医生提供安全便捷的数据处理解决方案。Agendia首席医疗官William Audeh博士说：“具有里程碑意义的MINDACT试验证明了MammaPrint测试的临床应用。结果显示，根据临床病理因素，46％的患者根据临床病理因素确定复发风险高，因此是辅助化疗的典型候选人，MammaPrint将其重新归类为低风险，表明他们是不太可能从化疗中受益。“乳癌是女性中最常见的癌症，在欧洲影响八分之一，每年有近500,000例新病例，确定以前选择用於化疗的女性的生活质量和成本效益可能没有显著的益处从它是相当可观的。(要了解有关MammaPrint BluePrint乳腺癌复发和分子亚型试剂盒的更多信息，请访问：www.agendia.com/diagnostic-products（仅限欧洲）)Agendia receives CE mark for MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping KitIRVINE, CA, AMSTERDAM, NETHERLANDS – 21 March 2018 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that its next-generation sequencing (NGS)-based MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit is now CE marked, enabling the Company to commercialize the device in Europe.Dr. Marjolaine Baldo, Commercial Vice President, EMEA at Agendia said:“Obtaining the CE mark for the MammaPrint BluePrint Kit is a huge milestone. For the first time, prestigious cancer centers across Europe will be able to run MammaPrint and BluePrint in their own labs, using their existing NGS instruments. As a result, patients will have better access to these vital tests and the significant benefits that they bring in personalizing breast cancer management.“We are proud of the drive, dedication and expertise of our team, partners and co-validation centers who, in recognizing the need for a decentralized solution, have worked tirelessly to develop, validate and deliver this important device to the market. We look forward to collaborating with leading breast cancer centers to provide them with these tools, enabling them to offer breast cancer risk-of-recurrence testing in-house.”MammaPrint analyzes 70 genes most associated with breast cancer recurrence to provide a 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. This new device, which combines both MammaPrint and BluePrint, can aid physicians in personalizing treatment management decisions for their patients by identifying women with early-stage breast cancer who are at a genomic Low or High Risk for distant metastasis within five years.The MammaPrint BluePrint Kit is an RNA-sequencing based version of Agendia’s existing MammaPrint and BluePrint tests, which are currently performed centrally at the Company’s CLIA-certified and CAP-accredited laboratories in Irvine, CA and Amsterdam, the Netherlands. The Kit was developed in partnership with Agilent Technologies using their SureSelect target enrichment system and with Bluebee, who provided the secure and convenient data processing solution for clinicians.Dr. William Audeh, Chief Medical Officer at Agendia, said:“The clinical utility of the MammaPrint test has been demonstrated by the landmark MINDACT trial. It showed, with the highest level of clinical evidence, that 46% of patients identified as high risk for recurrence according to clinical-pathological factors and who would therefore be typical candidates for adjuvant chemotherapy were reclassified as Low Risk by MammaPrint, indicating that they were unlikely to benefit from chemotherapy.“With breast cancer being the most common cancer in women, affecting one in eight in Europe and with almost 500,000 new cases a year, the quality-of-life and cost benefits of identifying women previously selected for chemotherapy that may not have significant benefit from it is considerable.”2,3To learn more about the MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, visit: www.agendia.com/diagnostic-products (Europe only)1 Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.2 Curado MP, et al. Cancer Incidence in Five Continents, Vol. IX, IARC Scientific Publications No. 160. IARCPress: Lyon: 2007.3 Ferlay J, et al.e. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed 04 August 2017http://www.ybe.com.tw/hot_86930.html通过欧盟CE认证 │ 经欧盟CE许可认证：可使用病理切片(FFPE)做乳癌基因检测分析。2022-09-062023-09-06
