TEST DIRECTORY

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Laboratory：Akiruno

○FGFR Gene Analysis (Urothelial cancer)

CODE：00X96 2(旧 0X96 8)

  • TEST NAME SPECIMEN
    REQUIREMENT
    （ｍL）     CONTAINER CAP COLOR STORE
    TEMPERATURE
    (STABILITY)     TURNAROUND
    TIME (DAY)     METHODOLOGY REFERENCE RANGE
    (UNIT)
  • FGFR Gene Analysis (Urothelial cancer)
    Unstained specimen slide
    5 to 10 sheets
    thickness 5μm
    Z10 Room temperature
     4-11 RT-PCR (Real Time PCR)

    Real-time PCR
    A type of nucleic acid amplification method based on the basic principle of PCR, which uses oligonucleotides that emit fluorescence upon decomposition to quantify target nucleic acids in real time by checking the fluorescent signal at each PCR cycle. A measurement method that enables.

COMMENT


This is to assist in the determination of the indication of Erdafitinib for the treatment of “adult patients with FGFR3 mutation or fusion gene, with progression after cancer chemotherapy, with unresectable urothelial carcinoma”.
We analyze FGFR3 gene mutations and fusion genes in pathological specimens. We cannot accept requests for materials other than pathological specimens.
The required percentage of tumor cells in the tissue on the slide must be 80% or more. Samples with less than 80% tumor cells may result in a false negative.
In the case of biopsy specimens or small specimens, the tumor area may be extremely small. In such cases, please increase the number of specimens you submit.
Please see below for important points to note when submitting unstained specimen slides.
Please avoid duplicate requests with other items.

●Submission conditions
Confirm that the unstained specimen slide has undergone histopathological evaluation and contains the required percentage of tumor cells (the percentage of tumor cells among all cells in the specimen). If the required percentage is not met, mark the tumor cell area on the reverse side of the unstained specimen slide. Please note that if the sample is submitted without marking, macrodissection may not be possible and the results may be affected, such as false negatives.
●About unstained specimen slides
Immediately immerse the collected tissue in a 10% neutral buffered formalin solution to fix it (Recommended fixation time is 6 to 48 hours; biopsy specimens should be fixed for approximately 3 to 6 hours). When submitting samples, please prepare serial sections of the specified thickness from formalin-fixed, paraffin-embedded (FFPE) blocks created within the last three years whenever possible. Please take great care to prevent contamination during sectioning, such as by changing the microtome blade for each sample. Also, please note that as nucleic acids are fragmented due to formalin fixation of tissues, analysis may not be possible depending on the type and composition of the fixative, fixation time, and storage condition of the specimen after fixation.
●About biopsy specimens
Biopsy specimens often contain only a small amount of specimen, and there is a possibility that most of the tissue itself has disappeared or that the tissue has become a piece of tissue that does not contain tumor cells. Please be aware of this in advance.

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