Illumina, Inc. (ILMN), Tuesday announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications. This single test interrogates over 500 genes to profile a patient's solid tumor, helping to increase the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment.

Illumina公司（ILMN）周二宣布，美国食品和药物管理局（FDA）批准其体外诊断（IVD）TruSight肿瘤学（TSO）综合测试及其前两个伴随诊断（CDx）适应症。这项单一测试询问了500多个基因，以分析患者的实体瘤，有助于增加识别免疫肿瘤学生物标志物或临床上可行的生物标志物的可能性，从而实现靶向治疗选择或临床试验注册。

TSO Comprehensive is FDA approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer's VITRAKVI (larotrectinib)..

TSO综合是FDA批准的CDx，用于鉴定神经营养性酪氨酸受体激酶（NTRK）基因融合阳性的成年和儿科实体瘤患者，这些患者可能受益于拜耳的VITRAKVI（拉罗替尼）治疗。。

The test is also approved to identify adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) that may benefit from treatment with Lilly's RETEVMO (selpercatinib).'FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community,' said Everett Cunningham, chief commercial officer of Illumina.

该测试还被批准用于鉴定转染（RET）融合阳性非小细胞肺癌（NSCLC）期间局部晚期或转移性重排的成年患者，这些患者可能受益于礼来的RETEVMO（selpercatinib）治疗Illumina首席商务官埃弗雷特·坎宁安（EverettCunningham）说，FDA批准TruSight Oncology Comprehensive及其配套诊断标志着我们的肿瘤学客户和社区期待已久的里程碑。

'We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients.'

“我们致力于与拜耳（Bayer）和礼来（Lilly）等行业领导者合作，推进癌症诊断，并帮助更多患者扩大精准肿瘤学的应用范围。