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 20% tumor nuclei.

The amount of tissue needed is dependent on a variety of preanalytical factors (eg, cellularity, ischemic time, fixation).

The FFPE input required is equivalent to a 4 to 5 micron slide thickness with a total tumor surface area of 100 mm(2). This can be created by combining material from multiple slides from one tissue block.

Preferred:

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block.

Acceptable:

Specimen Type: Tissue slide

Slides: 1 stained and 10 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.