TEST DIRECTORY

COMMENT

The purpose of this study is to analyze BRAF gene V600E mutations, EGFR gene mutation, HER2 (ERBB2) gene mutations, 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 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 when submitting 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 5μm thickness from formalin-fixed, paraffin-embedded blocks. Please submit the unstained slides after confirming that they contain 30% or more of tumor cells by HE stain. If the tumor cell percentage is less than 30%, mark the tumor area from the back of the unstained specimen slide. Please be aware that if the specimens are submitted without marking, it may affect the results, such as a false negative result. In addition, marked unstained specimen slides should be stored at room temperature and submitted in an object case (Z10).
・ Unstained specimen slides may not be analyzed depending on the type and composition of the fixative solution, fixation time, and storage conditions of the specimen after fixation, because nucleic acids are fragmented by formalin fixation of the tissue. Please submit samples taken within the last 3 years whenever possible. Please note that biopsy materials, in particu

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