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Laboratory：Akiruno

○AmoyDx Lung Cancer Multi-panel IVD (12-24 months)（Suspended beyond orders placed 05-31-2023）

CODE：00E83 5

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • INACTIVE
    AmoyDx Lung Cancer Multi-panel IVD (12-24 months)（Suspended beyond orders placed 05-31-2023）
    Unstained specimen slide
    Z10 Room temperature
     4-7 PCR (real-time PCR) and 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, and MET gene exon 14 skipping mutation 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 conditions
Unstained specimen slides should be histopathologically evaluated to ensure that tumor cells are present in a proportion greater than that required for testing. If the tumor cell percentage is not met, mark the tumor cell area from the back of the unstained specimen slide. Please be aware that if the specimens are submitted without   marking, macrodissection cannot be performed, which may affect the results, such as a false negative result.
●About 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). Please submit FFPE tissue created within the past 12-24 months. When submitting, please prepare serial sections of the specified thickness. Please be careful to avoid contamination by changing the microtome blade for each specimen during thin sectioning. Additionally, Please note that since nucleic acids are fragmented by formalin fixation of tissues, analysis may not be possible depending on the type and composition of the fixation solution, fixation time, and storage conditions of the sp

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