Roche  announced  that the  FDA granted Breakthrough Device Designation for the Ventana TROP2 (EPR20043) RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.

罗氏宣布，FDA授予Ventana TROP2（EPR20043）RxDx设备突破性器械认定。这是首个获得突破性器械认定的计算病理学伴随诊断（CDx）设备。

“This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology,” said Matt Sause, CEO of Roche Diagnostics. “This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalised treatment.”.

“这项FDA突破性设备认定再次表明了我们致力于提供能够实现更精确诊断的创新技术，”罗氏诊断公司首席执行官马特·索斯表示。“该解决方案利用我们在伴随诊断开发方面的行业领先专业知识，使用人工智能进行更深入的样本分析，有助于实现真正的个性化治疗。”

'This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.

“这一FDA突破性设备认定强调了我们的计算病理学平台在为癌症患者提供更个性化的治疗决策方面的潜力，”阿斯利康肿瘤血液学研发执行副总裁苏珊·加尔布雷思表示。

The FDA granting Breakthrough Device Designation has the potential to make a TROP2 CDx AI-driven system available sooner, which could aid in identifying patients with NSCLC most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca’s Datroway  (datopotamab deruxtecan-dlnk).

FDA授予突破性设备指定有可能使TROP2 CDx AI驱动系统更早可用，这可能有助于识别最有可能从第一三共和阿斯利康的Datroway（datopotamab deruxtecan-dlnk）治疗中受益的非小细胞肺癌患者。

The Ventana TROP2 (EPR20043) RxDx Device is a computational pathology device,

Ventana TROP2（EPR20043）RxDx 设备是一种计算病理学设备，

consisting of the TROP2 algorithm, navify Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200, DP 600) and the Ventana TROP2 (EPR20043) RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The Ventana TROP2 (EPR20043) RxDx Device analyses whole slide images of non-small cell lung cancer (NSCLC) tissue stained with TROP2 to compute a quantitative TROP2 score.

包括TROP2算法、navify数字病理图像管理系统、罗氏数字病理扫描仪（DP 200、DP 600），以及与OptiView DAB检测试剂盒配合使用的Ventana TROP2（EPR20043）RxDx检测，用于在BenchMark ULTRA IHC/ISH染色仪器上进行染色。Ventana TROP2（EPR20043）RxDx设备分析用TROP2染色的非小细胞肺癌（NSCLC）组织的全切片图像，计算定量的TROP2评分。

The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring (QCS), which enables a level of diagnostic precision not possible with traditional manual scoring methods..

该算法结合了阿斯利康专有的计算病理学平台——定量连续评分（QCS），这一平台实现了传统手动评分方法无法达到的诊断精确度。

The VentanaTROP2 (EPR20043) RxDx Device is indicated as an aid in identifying patients with previously treated

Ventana TROP2（EPR20043）RxDx 设备用于帮助识别先前接受过治疗的患者。

advanced or metastatic non-squamous NSCLC

先进的或转移性的非鳞状非小细胞肺癌

without actionable genomic alteration (AGA) most likely to benefit from treatment with Daiichi Sanko and AstraZeneca’s  Datroway (datopotamab deruxtecan-dlnk). A qualified pathologist is responsible for reviewing staining and image quality, as well as ensuring adequate tumor detection sensitivity and precision, in conjunction with histological examination, relevant clinical information, and proper controls..

没有可操作的基因组改变（AGA），最有可能从第一三共与阿斯利康的Datroway（datopotamab deruxtecan-dlnk）治疗中受益。一名合格的病理学家负责审查染色和图像质量，并确保足够的肿瘤检测灵敏度和精确度，同时结合组织学检查、相关临床信息以及适当的对照。

Following the pathologist assessment, the nDP TROP2 algorithm independently detects tumor cells and generates associated measures of TROP2 IHC staining intensity in both membrane and cytoplasm to compute the Normalised Membrane Ratio (NMR) score. The algorithm then classifies the TROP2 status as positive or negative based upon the pre-defined NMR cutoff..

遵循病理学家的评估后，nDP TROP2 算法独立检测肿瘤细胞，并生成与膜和细胞质中 TROP2 免疫组化染色强度相关的测量值，以计算标准化膜比率 (NMR) 分数。然后，该算法根据预定义的 NMR 阈值将 TROP2 状态分类为阳性或阴性。

Condition:

条件：

Non Small Cell Lung Cancer

非小细胞肺癌

Type:

类型：

drug

药物