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瞭解 MammaPrint+BluePrint 欣扶妳乳癌腫瘤基因雙效檢測
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國際許可及認證資格
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通過歐盟CE認證 │ 經歐盟CE許可認證:可使用病理切片(FFPE)做乳癌基因檢測分析。4
明達實業股份有限公司 23450 新北市永和區福和路389號9樓
NCCN更新治療指引,將MammaPrint納入乳癌檢測1級美國國家癌症資訊網(NCCN)和美國臨床腫瘤醫學會(ASCO)針對lymph-node positive患者,更新的NCCN治療指引中推薦的唯一基因組乳癌檢測工具美國國家癌症資訊網(NCCN)更新治療指引,將MammaPrint納入乳癌檢測1級NCCN推薦Agendia的MammaPrint為高水平的乳癌檢測,對於早期乳癌患者ER+,lymph-node negative和lymph-node positive(LN+1-3)MammaPrint現在是美國國家癌症資訊網(NCCN)和美國臨床腫瘤醫學會(ASCO)針對lymph-node positive患者,更新的NCCN治療指引中推薦的唯一基因組乳癌檢測工具。Agendia的公司今天宣布,美國國家癌症資訊網(NCCN)更新了其臨床實踐治療指引為包括MammaPrint 70-基因乳癌復發風險測試,有助於確定乳癌在lymph-node negative或positive(LN + 1-3)的ER+乳癌患者中復發的可能性。通過這些更新,MammaPrint獲得了基因組測試的最廣泛指導,具並且是同類測試中唯一具有1級的lymph-node negative和lymph-node positive疾病證據的檢測。NCCN美國國家癌症資訊網(National Comprehensive Cancer Network)治療指引是公認的癌症治療臨床標準,是由領先的癌症中心的臨床醫生和研究人員提供的。NCCN根據現有證據修訂推薦的實踐治療指引,最終目標是改善患者護理和結果。MammaPrint納入NCCN治療指引是基於具有里程碑意義的臨床試驗MINDACT的數據,這是一項隨機,前瞻性的III期試驗,評估了MammaPrint試驗的臨床效用。該研究於2016年發表在“ New England Journal of Medicine”上,發現近50%的患者最初根據臨床和病理因素確定其癌症復發風險高,因此而接受化療的患者實際上是低風險的。MammaPrint分析了與乳癌復發相關的70個最關鍵的基因,將每個乳癌患者分類為診斷後早期10年內發生轉移的“低風險”或“高風險”。您可以訪問www.nccn.org查看NCCN更新的治療指引。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.html NCCN更新治療指引,將MammaPrint納入乳癌檢測1級 │ 美國國家癌症資訊網(NCCN)和美國臨床腫瘤醫學會(ASCO)針對lymph-node positive患者,更新的NCCN治療指引中推薦的唯一基因組乳癌檢測工具 2021-04-28 2022-04-28
明達實業股份有限公司 23450 新北市永和區福和路389號9樓 http://www.ybe.com.tw/hot_293657.html
明達實業股份有限公司 23450 新北市永和區福和路389號9樓 http://www.ybe.com.tw/hot_293657.html
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MammaPrint+BluePrint欣扶妳乳癌腫瘤基因雙效檢測
Agendia獲得MammaPrint乳癌復發檢測和BluePrint分子亞型檢測的CE標誌

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MammaPrint + BluePrint Kit現已獲得CE認證,使公司能夠在歐洲將該設備商業化。

Agendia EMEA商務副總裁Marjolaine Baldo博士說:
“獲得MammaPrint和BluePrint Kit的CE標誌是一個重要的里程碑。歐洲著名的癌症中心將首次使用現有的NGS儀器在自己的實驗室中運行MammaPrint和BluePrint。因此,患者將能夠更好地獲得這些重要測試以及為她們個人化乳癌管理帶來的顯著益處。“為我們團隊、合作夥伴和共同驗證中心的努力得到激勵,對於奉獻精神和專業知識感到自豪,他們需要分工協力的解決方案,不知疲倦地開發、驗證並將這一重要設備推向市場。我們期待與領先的乳癌中心合作,為他們提供這些工具,使他們能夠在內部設立並提供乳癌復發風險測試。

MammaPrint分析了70個與乳癌復發最相關的基因,以提供低或高風險的癌症復發結果,而BluePrint分析80個基因,將患者的乳癌分子亞型分析。這種新設備結合了MammaPrint和BluePrint,可以幫助醫生為患者提供個人化的治療管理決策,通過識別患有早期乳癌的女性,她們在五年內基因組處於低或高風險的遠處轉移。
MammaPrint和BluePrint Kit是Agendia現有的MammaPrint和BluePrint測試的基於RNA測序的版本,目前在通過CLIA和CAP認證位在加利福尼亞州歐文和荷蘭阿姆斯特丹的Agendia實驗室集中進行。該試劑盒是與Agilent Technologies合作開發的,使用他們的SureSelect靶向富集系統和Bluebee,後者為臨床醫生提供安全便捷的數據處理解決方案。

Agendia首席醫療官William Audeh博士說:
“具有里程碑意義的MINDACT試驗證明了MammaPrint測試的臨床應用。結果顯示,根據臨床病理因素,46%的患者根據臨床病理因素確定復發風險高,因此是輔助化療的典型候選人,MammaPrint將其重新歸類為低風險,表明他們是不太可能從化療中受益。
“乳癌是女性中最常見的癌症,在歐洲影響八分之一,每年有近500,000例新病例,確定以前選擇用於化療的女性的生活質量和成本效益可能沒有顯著的益處從它是相當可觀的。

(要了解有關MammaPrint BluePrint乳腺癌復發和分子亞型試劑盒的更多信息,請訪問:www.agendia.com/diagnostic-products(僅限歐洲))


Agendia receives CE mark for MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit
IRVINE, 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.”2,3

To 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 2017

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