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FDA批准Illumina的TruSight肿瘤生物标志物测试
2024-08-28 05:12
- The FDA has approved Illumina’s (NASDAQ:ILMN) TruSight Oncology Comprehensive biomarker test and two companion diagnostic indications.
- TruSight was approved as a companion diagnostic to identify adults and children with solid tumors who are positive for NTRK gene fusions and may benefit from Bayer’s drug Vitrakvi, also known as larotrectinib.
- The diagnostic was also approved to identify adults with advanced or metastatic RET fusion-positive non-small cell lung cancer who may benefit from Eli Lilly’s (LLY) Retevmo, or selpercatinib.
- The company will begin shipping TruSight Oncology Comprehensive to customers later this year, Illumina added in a statement.
- A CE-marked version of the product has been available in Europe since 2022.
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