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HER2 Mutation Detection Kit

HER2 Mutation Detection Kit

  • Item No :ADx-HE01-R
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HER2 Mutation Detection Kit

    Qualitative detection of Detection of five mutations in HER2 gene

     

    HER2 mutations in exons 19~20, have been identified in approximately 2~4%of non–small-cell lung cancers (NSCLC). HER2 mutations appear to be found more commonly in never smokers with adenocarcinoma histology. The most common mutation is an in-frame insertion in exon 20. These insertions cause activation of downstream HER2-pathway components such as AKT and MEK. Drugs targeting HER2 include afatinib, traztuzumab, lapatinib, pertuzumab, neratinib and T-DMI. A recent study by Mazieres[1] highlighted the importance of screening for HER2 mutations in NSCLC and suggests that HER2-positive patients may be responsive to HER2-targeted therapy.

     

    Reference:

    1.       Buttitta F, et al., Mutational analysis of the HER2 gene in lung tumors from Caucasian patients: mutations are mainly present in adenocarcinomas with bronchioloalveolar features.Int J Cancer 2006

    2.       JulienMazie, et al., Lung Cancer That Harbors a HER2 Mutation: Epidemiologic Characteristics andTherapeutic Perspectives. Journal of clinical oncology 2013

     

    Intended Use

    The AmoyDx®HER2 Mutation Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection of 13 HER2 somatic mutations in human NSCLC formalin-fixed paraffin-embedded (FFPE) tissue, fresh tissue or pleural effusion samples.

    This kit is intended for research use only.

     

    Technological Principles

     

    The kit uses novel, proprietary primers and probes in a real-time PCR assay to detect 13 HER2 mutations in human genomic DNA. The mutant HER2 gene is amplified by the specific primers, and detected by the fluorescent probes.

     

    13 HER2 mutations detected by the kit:

     

    Name

    Mutation

    Base Change

    Cosmic ID

    HER2-M1

    A775_G776insYVMA

    2325_2326 ins12 (TACGTGATGGCT)

    12558

    HER2-M2

    A775_G776insYVMA

    2324_2325 ins12 (ATACGTGATGGC)

    20959

    HER2-M3

    G776>VC

    2326_2327 ins3 (TGT)

    12553

    HER2-M4

    P780_Y781insGSP

    2339_2340 ins9 (GGGCTCCCC)

    303948

    HER2-M5

    M774_A775insAYVM

    2322_2323 ins12 (GCATACGTGATG)

    21599

    HER2-M6

    P780_Y781insGSP

    2339_2340 ins9 (GGGCTCCCC)

    12555

    HER2-M7

    P780_Y781insGSP

    2340_2341 ins9 (GGCTCCCCA)

    12556

    HER2-M8

    G776>VC

    2326_2327 ins3 (TTT)

    12552

    HER2-M9

    G776R

    2326G>C

    /

    HER2-M10

    P780_Y781insGSP

    2339_2340 ins9 (CGGCTCCCC)

    /

    HER2-M11

    G776C

    2326G>T

    303938

    HER2-M12

    V777L

    2329G>T

    14062

    HER2-M13

    L755P

    2263_2264 TT>CC

    683


  • Contact Now

 To order, please contact Sales@amoydx.com.

Product Name

Type

Size (test/kit)

 Storage

 Ref. No.

AmoyDx® HER2 Mutation Detection Kit

Bulk

12

-20±5

ADx-HE01-R

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