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 Kit
“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 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
“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