TEST DIRECTORY

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Laboratory：Akiruno

○Thyroid Cancer Oncomine DxTT Multi-2 Gene CDx(46)FFPE

CODE：00W54 9

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • Thyroid Cancer Oncomine DxTT Multi-2 Gene CDx(46)FFPE
    Unstained specimen slide
    5 to 10 sheets
    thickness 5μm
    Z10 Room temperature
     6-11 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 RET fusion gene, RET gene mutation, and BRAF gene V600E mutation in genomic DNA and RNA extracted from cancer tissues, and to assist in determining the indications for the drugs listed separately for thyroid cancer and medullary thyroid cancer. In addition, information on the analysis of 46 genes that have not yet been approved by the pharmaceutical affairs bodies will also be reported for research purposes only. The percentage of tumor cells required for testing is 30% or more. See notes on submitting unstained specimen slides below.
Avoid duplicate requests in one sample. Since contamination has a greater effect on this test method, handle specimens with care when collecting them.
When requesting this test, ensure to also request the nucleic acid extraction item (item code: M9514)
●About submittion of unstained specimen slides
- Immerse the collected tissues in 10% neutral buffered formalin solution and fix them immediately (fixation time of 6~48 hours is recommended). For submission, prepare 5-μm-thick serial sections from formalin-fixed, paraffin-embedded tissue blocks.
- Unstained specimen slides should be histopathologically evaluated to confirm that the percentage of tumor cells (tumor cells as a percentage of total cells in the specimen) is at least the required percentage for the examination. If the required percentage is not met, mark the tumor cell area from the reverse side of the unstained specimen slide; otherwise, macrodissection will not be possible, which may result in a false negative or other negative results.
Since nucleic acids in unstained specimen slides are fragmented by formalin fixation of tissues, analysis may not be possible depending on the type and composition of fixation solution, fixation time, and storage conditions of the specimens after fixation. Submit samples collected within the past 3 years if possible, especially biopsy specimens, which are often in minute quantities and may contain only a small amount of tissue on paraffin sections, or may not contain tumor cells.

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