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Laboratory：Akiruno

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

CODE：00P24 9

  • 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 5μm
    Z10 Room temperature
     4-7 PCR (real-time PCR), RT-PCR (real-time PCR)

COMMENT


The purpose of this test is to analyze genomic DNA and RNA extracted from cancer tissue for BRAF V600E mutations,EGFR gene mutations, ALK fusion genes, ROS1 fusion genes, METgene exon 14 skipping mutations, KRAS G12C gene mutations, and RET fusion genes, and to determine whether or not drugs listed in the separate table are suitable for non-small cell lung cancer patients.
The required percentage of tumor cells for testing is 20% or more (recommended 30% or more). Please see below for points to note when submitting unstained specimen slides.
Please avoid making duplicate requests with other items. This test method is more susceptible to contamination, so please handle specimens with care.
When requesting this test, be sure to also request the nucleic acid extraction item (item code No: M9514).
*When submitting unstained specimen slides
-Immediately immerse the collected tissue in 10% neutral buffer formalin solution and fix it (fixation time is 6 to 10 minutes). (We recommend leaving the slide for approximately 48 hours.) When submitting the slide, please prepare serial sections at a thickness of 5 μm from the formalin-fixed paraffin-embedded tissue block.
-Unstained slides must be histopathologically evaluated and confirmed that they contain the required percentage of tumor cells for the test (the percentage of tumor cells among all cells in the specimen). If the required percentage is not met, please mark the tumor cell area from the back of the unstained slide. Please note if the slide is submitted without marking, macrodissection will not be possible, resulting in false negative results and it may affect the results.
- Please submit FFPE tissue prepared within 3 to 12 months.
- Since nucleic acids of unstained specimen slides are fragmented due to formalin fixation of tissue, analysis may be impossible depending on the type and composition of fixative, fixation time, and storage condition of specimen after fixation. Please note that biopsy materials in particular often contain very small amounts of specimens, and there may be cases where the tissue fragments on the paraffin sections are very small or may not contain tumor cells.

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