SAN DIEGO, March 16, 2022 /3BL Media/ -- Illumina, Inc. (NASDAQ:ILMN) announced the launch of TruSight™ Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. With its global launch first taking place in Europe, the in vitro diagnostic (IVD) kit will help inform precision medicine decisions for cancer patients across the continent.

这款新的体外诊断（IVD）综合基因组分析（CGP）套件涵盖了与欧洲医学肿瘤学指南，药物标签和临床试验相关的广泛突变以及当前和新兴的生物标志物，从每个患者的活检。传统测试，例如单个生物标志物测试和目标热点面板，它们分析的目标数量有限，这增加了缺少关键信息的机会。

Illumina肿瘤学总经理Kevin Keegan说：“这种开创性且准确的诊断套件可提供信息临床医生可以根据临床指南或临床试验，根据其肿瘤概况来帮助其患者与可用疗法相匹配。”“在Illumina，我们为将类似的创新带入市场而感到自豪，并处于解锁基因组以获得人类利益的最前沿。”

TSO综合（EU）通过评估DNA和RNA以及复杂的基因组特征，例如微卫星不稳定性（MSI）和肿瘤突变负担（TMB），评估了近30种实体瘤类型的517个癌症基因的生物标志物。这种全面的评估消除了从多个活检程序进行单独的顺序基因测试的需求。样本到临床报告的生成四到五天的快速周转时间与某些情况下的几周相比，临床医生可以就其癌症患者的个性化医学或临床试验入学做出决定。

"The most pressing challenge we face in profiling biomarkers from tumor samples is the ability to keep up with the pace of new biomarkers linked to new therapies and clinical trials," says Rhian White, Consultant Clinical Scientist at the All Wales Medical Genomics Services, Cardiff, UK. "We need a testing platform that can assess all these biomarkers, while at the same time preserving limited biopsy specimen. Comprehensive genomic profiling has proven to be this platform."

TSO综合（EU）是基于DNA和RNA含量的CGP标记的第一CE（Européenne），它已达到欧洲重要的质量和功效标准。CE-MARK是卫生当局偿还诊断测试的先决条件，在某些欧洲国家，在实验室可以使用新的测试方法之前，需要在某些欧洲国家进行诊断测试。作为经过验证的CE标记的IVD和套筒解决方案，TSO综合（EU）的引入提供了一个简化的过程，可通过任何病理实验室内部使用，因此可以对患者护理进行更近的时间进行测试。

“临床医生越来越多地将患者癌症的遗传学与他们的疗法相匹配，” Illumina首席医学官Phil Febbo解释说。“当医疗中心内部对癌症进行全面的基因组分析时，多学科团队包括一个分子病理学家，他对活检样本和生成的数据有更多控制，并且可以增加他们能够提供的知情病例的数量。证据表明，发生这种情况时发生。在疾病之旅中，更多的患者可以使用CGP和精密医学。”

Illumina通过与制药公司的合作伙伴关系的伴侣诊断（CDX）索赔越来越多，在监管批准后，随着时间的推移，随着时间的推移，它将添加到TSO综合（EU）中。这些CDX溶液将有助于释放突破性的靶向疗法和免疫疗法，从而改变癌症患者的生活。随着Illumina继续扩大与行业领导者的肿瘤学合作伙伴关系的广泛组合，该公司旨在推进癌症诊断和精密医学。

关于TSO Comprehensive
TRUSIGHT™肿瘤学综合是一种体外诊断测试，使用靶向下一代测序使用拟孔的核酸从福尔马林固定的，石蜡嵌入（FFPE）肿瘤组织样品中从癌症患者使用固体恶性肿瘤患者中提取的核酸来检测517个基因中的变异。Illumina^®NextSeq™ 550Dx instrument。该测试可用于检测单核苷酸变体，多核苷酸变体，DNA的插入，缺失和基因扩增，以及来自RNA的基因融合和剪接变体。该测试还报告了肿瘤突变负担（TMB）评分和微卫星不稳定性（MSI）状态。

The test is intended to provide tumor profiling information for use by qualified healthcare professionals in accordance with professional guidelines and is not conclusive or prescriptive for labeled use of any specific therapeutic product. To learn more about TruSight Oncology comprehensive, click here:www.illumina.com/tsocelrehens？scid = 2022-270pr5798

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