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Test ID: NTRK NTRK Gene Fusion Panel, Tumor


Ordering Guidance


Multiple oncology (cancer) gene panels are available. For more information see Hematology, Oncology, and Hereditary Test Selection Guide.



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: tissue 144 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 this document, the sizes are given as 4 mm x 4 mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3 mm x 1 mm x 10 slides: approximate/equivalent to 36 mm(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 fusions involving targeted regions of the NTRK1, NTRK2, and NTRK3 genes resulting in fusion transcripts.

 

This test is not useful for hematologic malignancies.

Genetics Test Information

This test uses next-generation sequencing to identify rearrangements (fusions) involving targeted regions of the NTRK1, NTRK2, and NTRK3 genes.

 

The assay was designed to detect the most common NTRK gene fusions and novel gene fusion partners in the targeted gene regions. For more information see NTRK RNA Targeted Gene Fusions.

 

Of note, this test is performed to evaluate rearrangements (fusions) within solid tumor samples. This test is not intended for use for hematological 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 US Food and Drug Administration 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, and NTRK3 genes (ie, NTRK gene fusions) are 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 therapies.

 

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

 

See Method Description for details regarding the targeted gene regions evaluated by this test.

Reference Values

An interpretive report will be provided.

Interpretation

The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.

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;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;15(12):731-747. doi:10.1038/s41571-018-0113-0

Day(s) Performed

Varies

Report Available

14 to 21 days

Test Classification

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

CPT Code Information

81194

88381

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

Forms

If not ordering electronically, complete, print, and send a Oncology Test Request (T729) with the specimen.

Mayo Clinic Laboratories | Genetics and Genomics Additional Information:

mcl-moltechtestmenu; mcl-oncology