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An NMPA approved NGS-based CDx kit solution.
Detects genetic variations (SNV, InDel, CNV, and Fusion).
Supports CDx applications for Erlotinib, Osimertinib, Crizotinib, Sunvozertinib in NSCLC.
Taken part in more than 50 CTA studies and 10 CDx programs.
Key Features and Benefits

● Officially approved by the NMPA (March 2022), covering 9 key lung cancer-related genes to support precision therapy decisions.


● The first NMPA-approved IVD for MET amplification, delivering reliable detection with added capability to identify MET exon 14 skipping.

● Accurately identifies complex multi-partner fusions, improving detection of rare and clinically meaningful alterations.

● Requires only 30 ng of DNA, ideal for limited tissue samples and small 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
NMPA-IVD
Tests/Kit
48
Alteration detected
SNV, InDel, CNV and Fusion
Sample type
FFPE tissue
Recommended DNA input
30-200ng
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
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