TEST DIRECTORY

COMMENT

This test is intended to detect AKT1 gene, PIK3CA gene, and PTEN gene mutations and determine the suitability of breast cancer drugs, using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens of cancer patients.
The percentage of tumor cells recommended for testing is 40％ or more (20％ at minimum).
Please see the Specimen Preparation Guide and the points below when submitting unstained specimen slides.
Please avoid duplicate requests with other items. This testing method increases the effects of contamination, so please be careful when handling the specimen.
Avoid freezing.

●When submitting unstained specimen slides
・Immediately immerse the collected tissue in a 10% neutral buffered formalin solution and fix it (we recommend fixation time of 6 to 48 hours). When submitting, please prepare 10 serial sections at a thickness of 5 μm or 5 serial sections at a thickness of 10 μm from FFPE tissue blocks.
・A minimum tumor cell percentage of 20% is required to detect mutations. However, a minimum tumor cell percentage of 40% is recommended to detect the CNV Homozygous deletion in the PTEN gene.
・Unstained specimen slides should be histopathologically evaluated to ensure that the required percentage of tumor cells (tumor cells as a percentage of total cells in the specimen) is present. For specimens with a tumor cell percentage below 20%, mark the tumor cell area on the back of each glass slide to be submitted using an oil-based pen or a similar marking tool so that the estimated tumor cell percentage after macrodissection reaches 20% or more. Avoid using a diamond-tipped pen. Please take note, if the slide is submitted without marking, macrodissection will not be possible, which may affect the results such as false negatives. In addition, please submit unstained specimen slides in an object case (Z10) and store them at room temperature.

*We cannot process requests for macrodissection for unstained specimen slides as described below:
　・Specimens without tumor area markings on the back of the unstained slide
　・Macrodissection guidance based on HE-stained example slides* with markings
　　*Please note that, in principle, HE-stained example slides cannot be returned once submitted.
　・Specimens with a tumor cell percentage below 20% and unable to undergo macrodissection
　　Example 1: Specimens with a marked area smaller than approximately 4 mm x 4 mm
　　Example 2: Specimens with a total marked area larger than 4 mm × 4 mm, with minute, patchy individual markings that make separation difficult, etc.
・Unstained specimen slides have fragmented nucleic acids due to formalin fixation of the tissue, so analysis may not be possible depending on the type and composition of the fixative, fixation time, and storage condition of the specimen after fixation. If possible, please submit samples taken within the past three years. In particular, please be aware that biopsy materials are often small in amount, and the tissue pieces on paraffin sections may be small or may not contain tumor cells.
・Prepare sections of approximately 4 mm × 4 mm or larger.
・For small tumor tissues such as biopsy materials, please submit multiple serial sections mounted on each glass slide to ensure a sufficient number of tumor cells.
・Avoid including specimens from different sites, such as primary and metastatic lesions, in the same tumor tissue specimen. We recommend sectioning from the same block as much as possible.

診療報酬

遺伝子関連・染色体検査判断料100点※2

supplementary information

2025/12/16→大原

2025/10/29

2025/10/29

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2025/12/16