HapOnco^® LungCDx EGFR/ALK NGS Testing Kit (Reversible termination sequencing technology) is used for in vitro qualitative detection of EGFR L858R and T790M mutations, EGFR exon 19 deletions and EML4-ALK fusion in formalin-fixed paraffin-embedded (FFPE) tissue specimens from non-small cell lung cancer (NSCLC) patients. The EGFR exon 19 deletions and L858R mutation are used for companion diagnostic testing of icotinib and gefitinib. The T790M mutation serves as a companion diagnostic test for osimertinib, while the ALK fusion mutation is used for companion diagnostic testing of crizotinib.

Drugs	Mutated Genes
Osimertinib	EGFR T790M
Icotinib/Gefitinib	EGFR L858R mutation & EGFR exon 19 deletions
Crizotinib	ALK Fusion

This assay kit is based on high-throughput sequencing platform, combining probe-based target capture and high-throughput sequencing technologies to detect the EGFR and ALK genes. DNA is extracted from tissue sections and fragmented. Specific adapter sequences are ligated to both ends of DNA fragments via enzymatic reaction. PCR amplification is performed to construct libraries and probe capture is used to enrich DNA fragments containing EGFR and ALK. Subsequently, high-throughput sequencing is conducted. The DNA library has specific adapter at both ends that can complementarily pair with sequencing chip. Fluorescent signals are released after each base pairing during sequencing, and the software identifies and processes these signals to generate DNA sequences. Finally, professional bioinformatics analysis software is used to analyze the gene sequences and detect mutations in the sample DNA, achieving high sensitivity and specificity in mutation detection.