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Tumor Mutation Burden
Test Code12354
CPT Codes
81479<br>** This test is not available for New York or Rhode Island patient testing **
Preferred Specimen
Submit 5-10 slides (10-micron sections) for resection or surgical specimens with H&E slide in slide holder or
Submit 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder
Submit 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder
Minimum Volume
5 slides of 10-micron sections for resection or surgical specimens • 10 slides of 10-micron sections for core needle biopsie
Other Acceptable Specimens
Formalin-fixed paraffin-embedded tissue accompanied by a circled H&E slide
Instructions
Do not freeze. Do not reject.
Specimen to be tested should contain a minimum of 20% tumor nuclei (with 30% preferred for optimal TMB estimation).
All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection, if warranted, is performed by the lab.
Tissue: Indicate the area to be examined. Submit in sterile biohazard plastic bag at room temperature or on ice pack in the summer.
Specimen to be tested should contain a minimum of 20% tumor nuclei (with 30% preferred for optimal TMB estimation).
All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection, if warranted, is performed by the lab.
Tissue: Indicate the area to be examined. Submit in sterile biohazard plastic bag at room temperature or on ice pack in the summer.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Refrigerated: Acceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report Available: 10-14 days
Clinical Significance
The Tumor Mutation Burden (TMB) assay is intended to be used as an aid in predicting response to immuno-oncology therapies among patients with advanced solid tumor malignancies. Higher somatic TMB has been associated with improved survival in patients receiving immune checkpoint inhibitor therapy across a wide variety of cancer types. The FDA has approved Pembrolizumab therapy as treatment for patients with metastatic solid tumors using TMB as a biomarker. Clinical trials may be available for patients with high TMB in certain solid tumors.
