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Test ID NTRK NTRK Gene Fusion Panel, Tumor


Advisory Information


 



Necessary Information


Pathology report (final or preliminary) at minimum containing the following information must accompany specimen in order 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 10% tumor nuclei.

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

-Minimum amount of tumor area: tissue 36 mm(2).

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

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

-For specimen preparation guidance, see Tissue Requirement for Solid Tumor Next-Generation Sequencing in Special Instructions. In this document, the sizes are given as 4mm x 4mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3mm x 1mm x 10 slides: approximate/equivalent to 36mm(2).

 

Preferred:

Specimen Type: Tissue block

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

 

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.

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


Useful For

Identifying solid tumors that may respond to targeted therapies by simultaneously assessing for rearrangements involving targeted regions of the NTRK1, NTRK2, and NTRK3 genes resulting in fusion transcripts

 

This test is not useful for hematologic malignancies.

Additional Tests

Test ID Reporting Name Available Separately Always Performed
SLIRV Slide Review in MG No, (Bill Only) Yes

Testing Algorithm

When this test is ordered, slide review will always be performed at an additional charge.

Method Name

Polymerase Chain Reaction (PCR)-Based Next-Generation Sequencing (NGS)

Reporting Name

NTRK Gene Fusion Panel

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Frozen 
  Refrigerated 

Clinical Information

Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the FDA for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.

 

Fusions involving the NTRK1, NTRK2, or NTRK3 genes (ie, NTRK gene fusions) form through intra- and interchromosomal rearrangements. NTRK gene fusions lead to activation of downstream MAPK, PIK, and STAT3 signaling pathways and act as oncogenic drivers of multiple types of pediatric and adult solid tumors. In solid tumors, the presence of an NTRK gene fusion is a biomarker for response to tropomyosin receptor kinase (TRK) inhibitor therapy.

 

This test assesses for fusions involving the NTRK1, NTRK2, and NTRK3 genes. The results of this test can be useful in guiding treatment of individuals with advanced solid tumors.

 

See the NTRK RNA Targeted Gene Fusions table in Special Instructions for details regarding the targeted gene regions evaluated by this test.

Reference Values

An interpretive report will be provided.

Interpretation

An interpretive report will be provided.

Clinical Reference

1. Drilon A, Laetsch TW, Kummar S: Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med 2018 Feb 22;378(8):731-739 doi: 10.1056/NEJMoa1714448

2. Cocco E, Scaltriti M, Drilon A: NTRK fusion-positive cancers and TRK inhibitor therapy. Nat Rev Clin Oncol 2018 Dec;15(12):731-747 doi: 10.1038/s41571-018-0113-0

Day(s) and Time(s) Performed

Monday through Friday; Varies

Analytic Time

14 days

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81479

81401 (NTRK3/ETV6 fusion if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
NTRK NTRK Gene Fusion Panel 93813-4

 

Result ID Test Result Name Result LOINC Value
606761 Result Summary 50397-9
606762 Result 81286-7
606763 Interpretation 69047-9
606764 Additional Information 48767-8
606765 Specimen 31208-2
606766 Source 31208-2
606767 Tissue ID 80398-1
606768 Released By 18771-6