MayoComplete Lung Cancer-Targeted Gene Panel with Rearrangement, Tumor
Use
This test is primarily used for the diagnosis and management of lung cancer, assisting in identifying somatic mutations and gene fusions within specific genes such as ALK, BRAF, EGFR, and others. It evaluates microsatellite instability and can guide the use of targeted therapies by identifying mutations or fusions that respond to specific inhibitors. The test aids in prognostic assessment and potentially determines eligibility for clinical trials, especially for mutations not currently targeted by FDA-approved therapies.
Special Instructions
A pathology report containing patient details and tissue collection information must accompany the specimen. Slide review always occurs at an additional charge, and insufficient specimens may result in test cancellation. Preferred specimens are formalin-fixed, paraffin-embedded tissue blocks or slides, with specific requirements for tumor cell percentage and slide preparation.
Limitations
The test does not assess for germline alterations and may not detect multi-exon deletions, duplications, or larger genomic copy number variants. Analytical sensitivity is limited; some variants may be missed if present below detection thresholds. The assay's effectiveness can be compromised by low tumor content or improper tissue treatment, such as decalcification. DNA variants of uncertain significance may be identified, requiring further interpretive context.
New York Approved
Methodology
NGS (Targeted)
Biomarkers
LOINC Codes
- 101378-8
- 82939-0
- 69047-9
- 48767-8
- 31208-2
- 80398-1
- 85069-3
- 62364-5
- 18771-6
Result Turnaround Time
12-20 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Formalin-fixed, paraffin-embedded tissue block
Collection Instructions
Submit a formalin-fixed, paraffin-embedded tissue block with an acceptable amount of tumor tissue. Required tumor nuclei can be obtained from up to 20 slides.
Causes for Rejection
All specimens will be evaluated for test suitability.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Ambient (preferred) |