The NovoFocus™ NSCLC CDx Test is a next-generation sequencing (NGS)-based diagnostic test that simultaneously analyzes tumor samples for multiple genomic mutations associated with several NMPA (formerly CFDA)-approved targeted therapies for non-small cell lung cancer (NSCLC).
The NovoFocus™ NSCLC CDx Test was developed based on the Thermo Fisher Ion Proton™ sequencing platform (approved by NMPA as “DA8600” in January 2017 for the diagnosis of cancer and inherited diseases). The reagent kits for sample processing and library construction, as well as the data analysis and result reporting software system, were developed by Novogene, to provide customers with an all-in-one diagnostic service.
- NMPA (formerly CFDA) approved product: Human EGFR, KRAS, BRAF, PIK3CA, ALK and ROS1 genomic mutation test kit (semiconductor sequencing method)
- Accurate detection and analysis: Analyzing 2789 clinical samples from 5 clinical institutes of high consistency with qPCR and Sanger sequencing method
- Validated companion diagnostics: Concordance with validated reference detection method of targeted therapies
- Complete and flexible system: Complete NGS system of instruments and reagents based on DA8600 sequencing platform, together with data analysis and result reporting
Companion Diagnostics Validation
Our product was compared with validated companion diagnostics and showed high consistency with these reference tests.
Retrospective Analysis of Drug Efficiency
The detection outcomes of Gefitinib, Osimertinib and Crizotinib sensitive mutations during the retrospective analysis of clinical samples were consistent with the ones before treatments. In addition, the expected ORR of the three targeted therapies were achieved accordingly.