TEST DIRECTORY

COMMENT

The purpose of this study is to analyze BRAF V600E mutation, EGFR L858R mutation, EGFR exon 19 deletion mutation, ALK fusion gene, and ROS1 fusion gene in genomic DNA extracted from cancer tissue to determine the indications for the drugs listed in the attached table for patients with non-small cell lung cancer.
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 with 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 also request the nucleic acid extraction item (item code No.: M951 4).
●About submission conditions
Unstained specimen slides should be histopathologically evaluated to ensure that tumor cells are present in a proportion greater than that required for testing. If the tumor cell percentage is not met, 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 immobilization time is 6-48 hours). When submitting, please prepare serial sections of the specified thickness from formalin-fixed, paraffin-embedded (FFPE) blocks made within the last three years if possible. Please be careful to avoid contamination by changing the microtome blade for each specimen during thin sectioning. Additionally, Please note that since nucleic acids are fragmented by formalin fixation of tissues, analysis may not be possible depending on the type and composition of the fixation solution, fixation time, and storage conditions of the specimens after fixation.
●About biopsy specimens
Please note that biopsy specimens are often minute amounts of specimen, and the tissue itself may be almost lost or may be a piece of tissue that contains no tumor cells.
Please submit at least 10 slides. Specimens with a low number of nucleated cells may not be tested because the required amount of nucleic acid cannot be obtained.
If the biopsy specimen is small (the area of the tissue section is 4mm² or less [2mm x 2mm or less]), please submit 15 or more specimens.

supplementary information

2020/12/23→大原

2020/06/13

2020/06/13

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2020/12/23