TEST DIRECTORY

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Laboratory：Akiruno

○Lung Cancer Oncomine DxTT Multi 7 Gene CDx (46) FFPE

CODE：00W82 8

  • 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 CDx (46) FFPE
    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 mutations, EGFR gene mutations, HER2(ERBB2) gene mutations, ALK fusion genes,ROS1 fusion genes,RETfusion genes, and METex 14 skipping mutations in genomic DNA and RNA extracted from cancer tissues, and to assist in determining whether drugs listed in the separate table are suitable for non-small cell lung cancer patients. In addition, for research purposes only, we will also report the results of analysis of 46 genes that have not been approved by the Pharmaceutical Affairs.
The required percentage of tumor cells for the tests is 30% or more. Please note the following of the General Testing Guide for important points when submitting unstained specimen slides.
Please avoid duplicate requests with other items. Since the effect of contamination is greater with this testing method, please handle samples with great care when collecting them.
When requesting this test, be sure to 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.-Unstained specimen slides must be histopathologically evaluated and confirmed that they contain the necessary percentage of tumor cells for the test (the percentage of tumor cells among all cells in the specimen). If the necessary percentage is not met, please mark the tumor cell area on the back of the unstained specimen slide. Please note that submitting unstained specimen slides without marking them may result in false negatives and other adverse effects on the results as macrodissection will not be possible. In addition, please submit unstained specimen slides in an object case (Z10) and store them at room temperature.
-Unstained specimen slides may not be analyzed depending on the type and composition of the fixative, fixation time, and storage conditions of the specimens after fixation, because nucleic acids are fragmented by formalin fixation of the tissue. If possible, please submit samples taken within the past 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 nucleated cells, the necessary amount of nucleic acid may not be obtained, making testing impossible. For small biopsy specimens (tissue section area of 4㎟ [2mm x 2mm or less]), please submit 15 or more slides.

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