TEST DIRECTORY

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Laboratory：Hachioji

○AmoyDx lung cancer multi-panel 7-gene (3-12 months)

CODE：0P24 6

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • AmoyDx lung cancer multi-panel 7-gene (3-12 months)
    Unstained specimen slide
    7 to 10 sheets
    thickness 5?m
    Z10 Room temperature
     4-7 PCR (real-time PCR), RT-PCR (real-time PCR)

COMMENT


The purpose of this study is to analyze BRAF V600E mutations, EGFR gene mutation, ALK fusion gene, ROS1 fusion gene, MET gene exon 14 skipping mutation, KRAS G12C gene mutation, and RET fusion gene in genomic DNA and RNA extracted from cancer tissues to determine the indications for the drugs listed in the attached table for patients with non-small cell lung cancer.
The percentage of tumor cells required for testing is 20% or more (recommended 30% or more). Please see below for notes on submitting unstained specimen slides.
Please avoid duplicate requests with other items. Since this test method is more susceptible to contamination, please handle the specimens with care when collecting them.
When requesting this test, please be sure to also request the nucleic acid extraction item (item code No.: M951 4).
●About submission of Unstained Specimen Slides
・The collected tissue should be immediately immersed in a 10% neutral buffered formalin solution for fixation (Recommended immobilization time is 6-48 hours). When submitting, please prepare serial sections of the 5μm thickness from formalin-fixed, paraffin-embedded (FFPE) blocks.If the tumor cell percentage is less than 20%, mark the tumor area from the back of the unstained specimen slide. Please be aware that if the specimens are submitted without marking, it may affect the results, such as a false negative result. In addition, marked unstained specimen slides should be stored at room temperature and submitted in an object case (Z10).
・Please submit FFPE tissue created within the past 3-12 months.
・Unstained specimen slides may not be analyzed depending on the type and composition of the fixative solution, fixation time, and storage conditions of the specimen after fixation, because nucleic acids are fragmented by formalin fixation of the tissue. Please note that biopsy specimens, in particular, are often minute quantities, and the tissue fragments themselves on paraffin sections may be small or may not contain any tumor cells.

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