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TEST:
LungCure™ CDx

Type:
Other Approval
Related tests:

Details

Evidence
LungCure™ CDx can be used in in vitro detections of genetic variations of EGFR, ALK, ROS1, KRAS, MET, ERBB2, BRAF, PIK3CA and RET genes associated with non-small cell lung cancer (NSCLC) patients, three of which (EGFR, ALK and ROS1) are approved under the NMPA standards for companion diagnostics (CDx), and provide comprehensive guidance on NSCLC targeted therapy. LungCure™ CDx has significantly improved the detection capability of rare variant types. It is the first NGS-based reagent kit approved in China which has the ability to detect MET amplification and MET exon 14 skipping. LungCure™ CDx significantly improves the detection performance and detection range of rare genetic variations, such as MET amplification, MET exon 14 skipping, ALK rearrangement, ROS1 rearrangement, RET rearrangement, etc., benefiting more patients clinically.
Cancer:
Non Small Cell Lung Cancer
Gene:
ALK (Anaplastic lymphoma kinase), BRAF (B-raf proto-oncogene), EGFR (Epidermal growth factor receptor), HER-2 (Human epidermal growth factor receptor 2), KRAS (KRAS proto-oncogene GTPase), MET (MET proto-oncogene, receptor tyrosine kinase)
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Drug:
sunvozertinib (DZD9008)
Method:
Next-Generation Sequencing (NGS)