EGFR, ALK/ROS1 Mutations Detection Kits

EGFR, ALK/ROS1 Mutations Detection Kits

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EGFR, ALK/ROS1 Mutations Detection Kits

    Amoy Diagnostics now offers a Lung Cancer Therapeutic Target Identification Solution to identify key drug targets for non-small cell lung cancer treatment.

        Assay Highlights:

    1.   Sensitive real-time PCR assay provides results in less than 2 hours.

    2.   Detection of multiple therapeutic targets from one Real-time PCR assay.

    3.   Simultaneous detection of 29 EGFR gene mutations, 26 ALK gene fusions and 14 ROS1gene fusions from one sample prep (following simultaneous DNA/RNA purification).

    4.   Economizes sample use.

    5.   Designed to work with FFPE tissue, as well as fine-needle aspiration and pleural effusion samples.

        Clinical Significance:

    For patients with non-small cell lung cancer(NSCLC)

    1.   Activating EGFR mutations, including exon 19 deletions and the L858R point mutation, predict response to tyrosine kinase inhibitor therapy, such as Gefitinib (Iressa-AstraZeneca) and Erlotinib (Tarceva-Roche).

    2.   EGFR T790M and exon 20 insertion mutations predict drug resistance.

    3.   Patients with ALK and ROS1 fusions likely to respond to treatment with crizotinib.

    4.   EGFR , ALK and ROS1 wild-type patients are suggested to be treated by chemotherapy.

        Technological Principles:

    1.  The AmoyDx® EGFR kit employs proprietary real-time PCR technology to detect 29 mutations in the EGFR gene. Target DNA is amplified with mutation-specific PCR primers, and the mutant amplicons are detected with a novel fluorescent probe.

         29 EGFR Gene Mutations detected with the kit:


    2. The AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection of 26 ALK gene fusions and 14 ROS1 gene fusions in human NSCLC formalin-fixed paraffin-embedded (FFPE) tissue samples.

    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 ALK and ROS1 gene fusions with specific primers and fluorescent probes.

    26 ALK gene fusions detected with the kit:


    14 ROS1 gene fusions detected with the kit:     


        Intended Use:

    CE marked for IVD use in Europe.

        Compatible PCR instruments:

    Stratagene Mx3000P™, ABI 7500, LightCycler®480 II.

        For more information, please contact

    Want to search for EGFR/ALK/ROS1 Mutations Detection Kit, welcome to visit our official website and wish the pleasant cooperation! If you have any other questions, please just send us an email, we are happy to be on service of you and give you more details.

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