TEST DIRECTORY

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Laboratory：Akiruno

○Lung Cancer Oncomine DxTT Multi 7 Gene CDxFFPE

CODE：00W79 2

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • Lung Cancer Oncomine DxTT Multi 7 Gene CDxFFPE
    Unstained specimen slide
    5 to 10 sheets
    thickness 5μm
    Z10 Room temperature
     6-9 Next Generation Sequencing (NGS)

    A method that uses a next-generation sequencer to simultaneously determine the base sequences of a huge number of DNA fragments.

COMMENT


The purpose of this test is to analyze BRAF gene V600E mutation, EGFR gene mutation, HER2 (ERBB2) gene mutation, ALK fusion gene, ROS1 fusion gene, RET fusion gene, and METex 14 skipping mutation with genomic DNA and RNA extracted from cancer tissue, and to assist in determining whether drugs listed in the separate table are suitable for non-small cell lung cancer patients.
The percentage of tumor cells required for the test is 30% or more. Please see below for points to note when submitting unstained specimen slides.
Please avoid making duplicate requests with other items. Note that this test method is more susceptible to contamination, so please be careful when collecting samples.
When requesting this test, please also request the nucleic acid extraction item (item code No.0M951 3).
*When submitting unstained specimen slides
-Immediately immerse the collected tissue in 10% neutral buffered formalin solution and fix it (fixation time of approximately 6 to 48 hours is recommended). When submitting, please prepare serial sections at a thickness of 5 μm from the formalin-fixed paraffin-embedded tissue block.
- Please confirm that the unstained specimen slides have been histopathologically evaluated and are present at least the tumor cell percentage (tumor cells as a percentage of total cells in the specimen) required for the test. If the required ratio is not met, please mark the tumor cell area from the back of the unstained specimen slide. Please note that submitting the slide without marking will not allow macrodissection, which may affect the judgment result, such as false negatives. In addition, submit unstained specimen slides in an object case (Z10) and store them at room temperature.
- Unstained specimen slides may become impossible to analyze depending on the type and composition of the fixative, fixation time, and storage conditions of the specimens after fixation, because the nucleic acids are fragmented by formalin fixation of the tissue. If possible, please submit samples taken within three years. Note that biopsy materials in particular often contain very small amounts of specimen, and the tissue fragments on the paraffin sections may be very small or may not contain tumor cells.
*About biopsy specimens
-Please submit 10 or more slides.
-For samples with a low number of nucleic cells, the necessary amount of nucleic acid may not be obtained, making testing impossible. For small biopsy specimens (tissue slice area 4㎟or less [2mm x 2mm or less]), please submit 15 or more slides.

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