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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Tumor Mutation Burden
Test Code12354
CPT Codes
81479<br><strong>This test is not available for New York or Rhode Island patient testing.</strong>
Preferred Specimen
5-10 slides (10-micron sections) for resection or surgical specimens with H&E slide in slide holder, or 10-20 slides (10-micron sections) for core needle biopsies
Other Acceptable Specimens
Paraffin-embedded tissue block accompanied by a circled H&E slide indicating the area to be examined
Instructions
Do not freeze. Do not reject. Submit in sterile biohazard plastic bag at room temperature or on ice pack in summer. Specimen to be tested should contain a minimum of 10 percent tumor nuclei.
All specimens must be accompanied with Pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.
All specimens must be accompanied with Pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.
Transport Container
Sterile biohazard bag
Transport Temperature
Room temperature or refrigerated (cold packs)
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 performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Setup Schedule
Set up: Daily; Report available: 11-15 days
Reference Range
See Laboratory Report
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.
