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Laboratory：Hachioji

○Oncomine Dx Target Test 46-gene analysis for multi-research (FFPE)（Suspended beyond orders placed 08-10-2023）

CODE：0E53 1

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • INACTIVE
    Oncomine Dx Target Test 46-gene analysis for multi-research (FFPE)（Suspended beyond orders placed 08-10-2023）
    Unstained specimen slide
    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.
other material

COMMENT


It is intended to analyze the BRAF V600E mutation, EGFR gene mutation, ALK fusion gene, ROS1 fusion gene, and RET fusion gene 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 carcinoma.
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 of 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 simultaneously request the item "Nucleic acid extraction (item code No.: M951 4)."
●About Submission Conditions
Unstained specimen slides must have been histopathologically evaluated to ensure that tumor cells are present in a percentage greater than that required for testing. If the tumor cell percentage is not satisfied, 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 fixation time is 6-48 hours.) When submitting, please prepare serial sections of the designated thickness from formalin-fixed, paraffin-embedded (FFPE) blocks prepared within the last three years to the extent possible. Please be careful to avoid contamination by changing the microtome blade for each specimen during thin sectioning, for example. Additionally, Please note in advance that since nucleic acids are fragmented by formalin fixation of tissues, analysis may not be possible depending on the type and composition of the fixative, fixation time, and preservation conditions of the specimen after fixation.
●About Biopsy Specimens
Please note in advance that since biopsy specimens are often minute amounts, the tissue itself may be almost lost or may be a piece that contains no tumor cells.

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