Ordering Guidance

For the preferred test to assess for somatic hotspot mutations in the TERT, IDH1, and IDH2 genes, order IDTRT / IDH1, IDH2 and TERT Mutation Analysis, Next-Generation Sequencing, Tumor.

If this test is ordered with IDHT / IDH1 and IDH2 Mutations Analyses, Next-Generation Sequencing, Tumor, this test will be canceled and ordered as IDTRT.

Necessary Information

A pathology report (final or preliminary), at minimum containing the following information, must accompany specimen for testing to be performed:

1. Patient name

2. Block number-must be on all blocks, slides, and paperwork (can be handwritten on the paperwork)

3. Tissue collection date

4. Source of the tissue

Specimen Required

This assay requires at least 5% nuclei of tumor cells/cells of interest.

-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue144 mm(2)

-These amounts are cumulative over up to 10 unstained slides and must have adequate percent nuclei of tumor cells/cells of interest.

-Tissue fixation: 10% neutral buffered formalin, not decalcified

-Cytology fixatives: Cytology smears fixed in alcohol and thin preps fixed with CytoLyt.

Preferred: Submit 3, if available, or 2 of the following specimens.

Acceptable: Submit at least one of the following specimens.

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.

Specimen Type: Tissue slide

Slides: 1 Hematoxylin and eosin-stained and 10 unstained

Collection Instructions:

Submit the followings slides:

1 Slide stained with hematoxylin and eosin

AND

10 Unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.

Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block.

Additional Information: Unused unstained slides will not be returned.

Specimen Type: Cytology slide (direct smears or ThinPrep)

Slides: 1 to 3 Slides

Collection Instructions: Submit 1 to 3 slides stained and coverslipped with a total of 5000 nucleated cells (preferred) or at least 3000 nucleated cells (minimum).

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.

Additional Information: Cytology slides will not be returned. An image of the slides will be stored per regulatory requirements.