TEST DIRECTORY

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Laboratory：Akiruno

○Oncomine Dx Target Test Multi-research 46 Gene Analysis (FFPE)（Suspended beyond orders placed 12-28-2021）

CODE：0R613 3

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • INACTIVE
    Oncomine Dx Target Test Multi-research 46 Gene Analysis (FFPE)（Suspended beyond orders placed 12-28-2021）
    Unstained specimen slide
    15 pieces
    Z10 Room temperature
     7-11 Next Generation Sequencing (NGS)

COMMENT


The purpose of this study is to analyze BRAF V600E mutation, EGFR L858R mutation, EGFR exon 19 deletion mutation, ALK fusion gene, and ROS1 fusion gene in genomic DNA extracted from cancer tissue 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 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). When submitting, please prepare serial sections of the specified thickness from formalin-fixed, paraffin-embedded (FFPE) blocks made within the last three years if possible. 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 specimens after fixation.
●About biopsy

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