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HelpTest ID: MCLNR MayoComplete Lung Rearrangements, Rapid Test, 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 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 36 mm(2)
-Minimum amount of tumor area: tissue 18 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
Preferred:
Specimen Type: Tissue block and cell block
Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block or cell block with acceptable amount of tumor tissue.
Acceptable
Specimen Type: Tissue slides
Slides: 1 Stained and 5 unstained
Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 5 unstained, nonbaked slides wit 5-micron thick sections of the tumor tissue.
Note: The total amount of required tumor nuclei can be obtained by scraping up to 5 slides from the same block.
Additional Information: Unused unstained slides will not be returned.
Specimen Type: Cytology slides (direct smears)
Slides: 1 to 3 Slides for smears
Collection Instructions: Submit 1 to 3 slides unstained or stained with Diff Quik or Pap and coverslipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 nucleated cells.
Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.
Additional Information: Cytology slides used in testing will have everything scraped and not be returned.
Useful For
Identifying lung tumors that may respond to targeted therapies by simultaneously assessing multiple genes involved in rearrangements resulting in fusion transcripts
Diagnosing and managing patients with lung cancer
Genetics Test Information
This test identifies specific gene fusions (rearrangements) involving the ALK, ROS1, and RET genes, MET exon 14 skipping, and expression imbalance for ALK, ROS1, RET, NTRK1, NTRK2, and NTRK3 genes. See Targeted Genes and Methodology Details for MayoComplete Lung Rearrangements for details regarding the targeted gene regions evaluated by this test.
Expression imbalance assays have the benefit that provide an indication of the presence of a fusion not covered by the specific fusion panel.
This test is performed to evaluate gene fusions (rearrangements) within solid tumor, in particular lung cancer, specimens.
Additional Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| SLIRV | Slide Review in MG | No | Yes |
Testing Algorithm
When this test is ordered, slide review will always be performed at an additional charge.
Method Name
Polymerase Chain Reaction (PCR)
Reporting Name
MayoComplete Lung RearrangementsSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| 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, 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 inhibitor therapy.
Lung cancers harboring ALK rearrangements are resistant to epidermal growth factor receptor tyrosine kinase inhibitors but may be highly sensitive to ALK inhibitors, like Xalkori (crizotinib). The drug Xalkori works by blocking certain kinases, including those produced by the abnormal ALK gene. Clinical studies have demonstrated that Xalkori treatment of patients with tumors exhibiting ALK rearrangements can halt tumor progression or result in tumor regression.
RET rearrangements occur in approximately 2.5% to 10% of sporadic papillary thyroid cancer(1) and 1% to 3% of non-small cell lung cancer. The most prevalent fusions are KIF5B exon 15 - RET exon 12 and KIF5B exon 16 - RET exon 12, which represent over 75% of RET fusions.
ROS1 (c-ros oncogene 1), originally described in glioblastomas, has been identified as a potential relevant therapeutic target in lung adenocarcinoma. Crizotinib has shown in vitro activity and early evidence of clinical activity in ROS1-rearranged tumors.
Many cases of METex14 alterations are found in lung adenocarcinomas, these events have a much higher incidence in pulmonary sarcomatoid carcinomas. Approximately 20% to 30% of sarcomatoid carcinomas harbor METex14 alterations.
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. Vaishnavi A, Capelletti M, Le AT, et al: Oncogenic and drug-sensitive NTRK1 rearrangements in lung cancer.Nat Med. 2013 Nov;19(11):1469-1472
2. US Food and Drug Administration (FDA): Table of Pharmacogenomic Biomarkers in Drug Labeling. FDA; Updated August 11, 2022, Accessed February 3, 2023. Available at www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling
3. Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368(25):2385-94. doi: 10.1056/NEJMoa1214886
4. Sehgal K, Patell R, Rangachari D, Costa DB. Targeting ROS1 rearrangements in non-small cell lung cancer with crizotinib and other kinase inhibitors. Transl Cancer Res. 2018;7(Suppl 7):S779-S86. doi: 10.21037/tcr.2018.08.11
5. Drilon A, Oxnard GR, Tan DSW, Loong HHF, Johnson M, Gainor J, et al. Efficacy of Selpercatinib in RET fusion-positive non-small-cell lung cancer. N Engl J Med. 2020;383(9):813-24. doi: 10.1056/NEJMoa2005653
6. 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
7. Frampton GM, Ali SM, Rosenzweig M, Chmielecki J, Lu X, Bauer TM, et al. Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer Discov. 2015;5(8):850-9. doi: 10.1158/2159-8290.CD-15-0285
Day(s) Performed
Monday through Friday
Report Available
4 to 8 daysTest 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
81449
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| MCLNR | MayoComplete Lung Rearrangements | 73977-1 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 618280 | Result | 82939-0 |
| 618281 | Interpretation | 69047-9 |
| 618282 | Additional Information | 48767-8 |
| 618283 | Specimen | 31208-2 |
| 618284 | Tissue ID | 80398-1 |
| 618285 | Method | 85069-3 |
| 618286 | Disclaimer | 62364-5 |
| 618287 | Released By | 18771-6 |
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