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An NMPA approved NGS-based CDx kit solution.
Detects genetic variations (SNV, InDel, CNV, and Fusion).
Detects genetic variations (SNV, InDel, CNV, and Fusion).
Taken part in more than 10 CTA studies and 4 CDx development projects.
Key Features and Benefits

● NMPA-approved NGS-based CDx kit, covering 9 lung cancer-associated genes to guide therapy selection.


● Inclusion of PIK3CA gene coverage on top of the recommended 8 genes by the guidelines.

● The detection of rare mutations.

● 30ng of DNA input from puncture biopsies.




Performance Validations
Biomarker Panels



EGFR
MET
ERBB2
KRAS
BRAF
PIK3CA
ALK
ROS1
RET



Non-small cell lung cancer (NSCLC)
EGFR、ALK、ROS1、RET、MET、ERBB2、BRAF、KRAS
Colorectal cancer (CRC)
BRAF、KRAS
Specifications
Certification
CE-IVD
Tests/Kit
48
Alteration detected
SNV, InDel, CNV and Fusion
Sample type
FFPE tissue
Sequencing Type
PE300
Sequencer
Illumina MiSeqDx
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Biomarker Discovery & Translational Research
Clinical Trial Design & Patient Recruitment
Global Capabilities for Clinical Studies
CDx Development & Commercialization
Genomic Data Solutions
ctDNA Monitoring Portfolio
Other
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