Formalin-fixed, paraffin embedded tissue or cytology fine needle aspirate smears; 2000 tumor cells minimum requirement, or ≥20% tumor cells from tissue sections

Formalin-fixed, paraffin embedded tissue block, or ten unstained 4 micron-thick sections on non-plus slides and one H&E stained section.

Specimens that have been decalcified will not be accepted.

10-14 days upon receipt in laboratory

Fusion or mutation not detected

The panel targets gene rearrangements of the NTRK1, NTRK2 and NTRK3. NTRK gene rearrangements represent the fusion between NTRK1, NTRK2, or NTRK3 with various partner genes that result in constitutive kinase activity.

NTRK gene rearrangements are found at high frequencies in rare cancer types including secretory carcinoma of the breast and salivary gland, congenital or infantile fibrosarcoma and at lower frequencies (commonly  <1%) in a range of other tumor types.

The FDA granted approval for use of larotrectinib for adult and pediatric patients with solid tumors that have NTRK gene rearrangements that are either metastatic or non-resectable, who have no satisfactory alternative treatments or whose cancer has progressed following treatment (based on data from the LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431) clinical trials).

Total nucleic acid including RNA is isolated from tumor specimens. Reverse transcription, anchored multiplexed PCR for targeted next- generation sequencing is performed.

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