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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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通過美國FDA(食品藥物管理局)MammaPrint獲得五項認證 │ 美國食品藥物管理局FDA在2007年批准MammaPrint欣扶妳乳癌腫瘤基因雙效檢測,使用在乳癌患者的確診病例手術後的檢體做檢測,來預測乳癌是否會在5或10年內復發。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
通過美國FDA(食品藥物管理局)MammaPrint獲得五項認證
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美國食品藥物管理局FDA在2007年批准MammaPrint欣扶妳乳癌腫瘤基因檢測,使用在乳癌患者的確診病例手術後的檢體做檢測,來預測乳癌是否會在5或10年內復發。

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(認證編號:K101454、K080252、K070675、K081092、K141142)

1. 用乳癌腫瘤基因表現來評估乳癌復發與遠端轉移風險的體外診斷檢測
2. 美國加州與荷蘭阿姆斯特丹兩大實驗室品質管制,基因晶片合併DNA及RNA品質鑑定符合基因檢測標準
3. 高密度微陣列掃描技術
4. 新鮮檢體RNARetain保存技術
5. 突破過去的檢測年齡限制,檢測年齡最高可達87歲
6. FFPE(福爾馬林固定石蠟包埋檢體)可應用於MammaPrint分析70個基因乳癌復發風險檢測

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