PD-1/PD-L1 inhibitors have been widely used in the routine treatment of solid tumors, and PD-L1 detection plays a very important role in predicting the efficacy of immune checkpoint inhibitors.
The PD-L1 companion diagnostic kit developed by MEDx had clinical comparative studies on more than 1,000 samples of non-small cell lung cancer patients in four large-scale authoritative clinical research centers in China. The results showed that the positive coincidence rate between PD-L1 (E1L3N) of MEDx and PD-L1 detection kit (28-8) was 96.58%, and the negative coincidence rate was 98.31%, total coincidence rate was 97.77%. MEDx’s PD-L1 IHC kit showed excellent performance.
The PD-L1 Kit of MEDx has been approved as a companion diagnostic reagent for non-small cell lung cancer. Combined with the needs of clinical practical applications, MEDx has actively extended verification of more indications, and the results show excellent performance. The consistency comparison between MEDx’s PD-L1 and FDA approved imported reagent (22C3, Dako) in the three cancer types showed that the total coincidence rate was 97.6% for head and neck squamous cell carcinoma, 95.3% for gastric cancer, and 95.3% for gastric cancer. The total coincidence rate for squamous cell carcinoma was 95.0% .
The approved compatible instrument of MEDx’s PD-L1 is Leica Bond. In order to expand the scope of application, the staining of MEDx’s on the Ventana (Roche) BMK automatic immunohistochemical staining machine platform is consistent with that on the Leica BOND automatic immunohistochemical staining machine The total coincidence rate was 94.59%, indicating that this product has strong applicability and can be flexibly applied to a variety of detection platforms to meet more scientific research needs.
In order to cooperate with clinical application and improve the efficiency and accuracy of interpretation, MEDx is developing artificial intelligence (AI) interpretation software and an integrated machine system based on PD-L1 kit. AI software can assist pathological interpretation, which can greatly reduce the time and subjective error of the pathologist.
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