ALK Gene Fusions and ROS1Gene

ALK Gene Fusions and ROS1Gene Fusions Detection Kit

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ALK Gene Fusions and ROS1Gene Fusions Detection Kit

    For qualitative detection of 26ALKgene fusionsand 14 ROS1gene fusions


    ALKgene fusionsand ROS1 gene fusions define unique molecularsubsetsof non–small-cell lung cancer (NSCLC).EML4,KIF5B,TFG,KLC1etc., are identified as fusion partnersof ALK;SLC34A2,CD74,SDC4,EZRetc.,are identified as fusion partnersof ROS1.These fusions lead to constitutive kinase activity and activation of downstream pathways, leading to carcinogenesis.It has been reported that the presence of theALKgene fusions and ROS1gene fusionsarecorrelated with the efficacy of TKI therapy.


    Detection of ALK and ROS1 fusions in patients with advanced NSCLC indicates eligibility for treatment with ALK inhibitor crizotinib.


    The AmoyDx®ALK Gene Fusions and ROS1 Gene Fusions Detection Kitis an in vitronucleicacidamplification test intended for qualitative detection of 26 ALK gene fusions and 14 ROS1 gene fusions.


    Intended Use

    CFDA approved for clinical use in China and CE marked for IVD use in Europe. 


    Technological Principles

    The kit is based on three major processes:

    (1) Specimen preparation to isolate total RNA from NSCLC FFPE samples;

    (2) Reverse transcription of the target RNA to generate complementary DNA (cDNA);

    (3) Simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.

    26 ALK and 14 ROS1 fusions detected by the panel:

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ALK fusions and ROS1 fusions Detection Kit





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