At least 20% tumor is required for this assay. The amount of tissue needed is dependent on a variety of preanalytical factors (eg, cellularity, ischemic time, fixation). In general, the minimum specimen adequacy for this test is approximately a 6 mm 2 area of tissue (can be over multiple slides from one tissue block) or 5,000 total cells (5,000 total nucleated cells if using cytology slides).

A pathology report must accompany specimen in order for testing to be performed. Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or 1 slide stained with hematoxylin and eosin and 8 unstained, non-baked slides with 5-microns thick sections of the tumor tissue

Formalin-fixed, parrafin-embedded  (FFPE) tissue block

Unused portion of block will be returned

 One (1) slide stained with hematoxylin and eosin and ten (10) unstained, non-baked slides with 5-micron thick sections of the tumor tissue with at least 6 mm² area of tissue (can be over multiple slides) and 20% tumor nuclei, 1 stained and cover-slipped cytology slide with at least 5,000 total nucleated cells and at least 20% tumor cells.

Ambient (preferred)

Frozen

Refrigerated

PCR-Based Next Generation Sequencing

An interpretive report will be provided

Medical necessity