BRCA1 and BRCA2 Gene Mutation Detection Kit

BRCA1 and BRCA2 Gene Mutation Detection Kit
The AmoyDx^® BRCA1 and BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing), is intended for qualitative detection of BRCA1 and BRCA2 gene mutations (including all coding exons, exon-intron boundaries) in extracted DNA from human blood samples, fresh tissue or neutral formalin-fixed paraffin-embedded (FFPE) tissue samples. The kit is intended to be used to assess BRCA1 and BRCA2 gene status in ovarian cancer and breast cancer patients.

Technological Principles
The test kit is based on Halo-shape ANnealing and Defer-Ligation Enrichment system (HANDLE system) technology which is an improved Molecular Inversion Probe (MIP) technology to capture the target gene region. The unique molecular identifier (UID) is introduced to both ends of each DNA fragment, and traces back to the original template for error correction. The library construction time of HANDLE system is 5 hours with 1 hour hands-on time.
The probe contains an extension arm and a ligation arm which are complementary to the target gene region. First, the extension arm and ligation arm are anchored to the target gene region, and the DNA is extended from the extension arm to the ligation arm by the function of DNA polymerase. Next, the nicks are connected with the ligase to generate the circular products. The remaining linear probes, single-strand and double-strand nucleic acid are digested using exonuclease. Finally, the universal PCR amplification is performed to enrich the target libraries.