Recently, the "Chinese Expert Consensus on Clinical Testing standards of PD-L1 Expression Clinical Detection in Non-Small Cell Lung Cancer (2023 Edition)" was officially released in the Chinese Journal of Pathology. It aims to provide better guidance for the standardized use of PD-L1 detection in the clinical diagnosis and treatment process of non-small cell lung cancer (NSCLC). In this updated consensus, the AmoyDx® PD-L1 (E1L3N) assay (NMPA approval number 20223400313) was prioritized as companion diagnostics for Pembrolizumab.
Based on the 2020 version, the latest consensus brings the following updates for the PD-L1 antibody with clone number E1L3N:
● The clone number E1L3N is a priority recommendation as a companion diagnostic for late-stage first-line treatment with Pabolizumab, as well as a recommendation for treatment with Nivolumab.
● High consistency of three antibodies with clone numbers 22C3, SP263, E1L3N.
About AmoyDx® PD-L1(E1L3N) assay:
The AmoyDx® PD-L1 (E1L3N) assay obtained approval from the China NMPA in March 2022 as a companion diagnostic for pembrolizumab. It is the first domestic reagent approved for immunotherapy companion diagnostics in China. The assay is highly consistent with the results of the 22C3 monoclonal antibody assay, and its innovative, ready-to-use design enables rapid clinical detection. Meanwhile, its compatibility with multiple testing platforms such as Leica, Ventana, DAKO, facilitates the widespread adoption of PD-L1 testing in hospitals, ultimately benefiting a majority of tumor patients.
Based on the 2020 version, the latest consensus brings the following updates for the PD-L1 antibody with clone number E1L3N:
● The clone number E1L3N is a priority recommendation as a companion diagnostic for late-stage first-line treatment with Pabolizumab, as well as a recommendation for treatment with Nivolumab.
● High consistency of three antibodies with clone numbers 22C3, SP263, E1L3N.
About AmoyDx® PD-L1(E1L3N) assay:
The AmoyDx® PD-L1 (E1L3N) assay obtained approval from the China NMPA in March 2022 as a companion diagnostic for pembrolizumab. It is the first domestic reagent approved for immunotherapy companion diagnostics in China. The assay is highly consistent with the results of the 22C3 monoclonal antibody assay, and its innovative, ready-to-use design enables rapid clinical detection. Meanwhile, its compatibility with multiple testing platforms such as Leica, Ventana, DAKO, facilitates the widespread adoption of PD-L1 testing in hospitals, ultimately benefiting a majority of tumor patients.
AmoyDx has successfully held the 2023 Distributors Annual Meeting at the headquarter in Xiamen, China, on January 22-23, 2024
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