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Tumor Mutation Burden : 1016910
Test CodeMDFCPTMB : 1016910
Alias/See Also
TMB, Tumor Mutation Burden, TML, Tumor Mutation Load, Immunotherapy, Immuno-oncology, Keytruda, Pembrolizumab. Immune checkpoint inhibitor
CPT Codes
81479
Instructions
Tissue.
Transport Container
Submit paraffin embedded tissue block accompanied by a circled H&E slide indicating the area to be examined: submit in sterile biohazard plastic bag.
or
Slides: submit 5-10 slides (10-micron sections) for resection or surgical specimens or 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder at ambient temperature.
Specimen to be tested should contain a minimum of 20 percent tumor nuclei (with 30 percent preferred for optimal TMB estimation). Decalcified specimens are not acceptable.
Transport Temperature
Paraffin embedded Tissue: Ambient or on ice pack in summer; Slides: Ambient.
Specimen Stability
Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen.
Methodology
Next Generation Sequencing (NGS)
Setup Schedule
Sunday - Saturday
Report Available
10-14 days
Limitations
Laboratory test results should always be considered in the context of clinical observations. 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.
Reference Range
An interpretive report will be provided.
TMB score is estimated by dividing the number of detected somatic missense and nonsense mutations and coding indels by the number of exonic bases with > 60 x coverage and expressed as the number of mutations per megabase (mut/Mb). Estimated TMB scores are further adjusted to a standardized TMB score by alignment to commercially available reference standards.
Standardized TMB scores are categorized as follows: TMB Low (< 10 mut/Mb) and TMB High (≥ 10 mut/Mb).
TMB score is estimated by dividing the number of detected somatic missense and nonsense mutations and coding indels by the number of exonic bases with > 60 x coverage and expressed as the number of mutations per megabase (mut/Mb). Estimated TMB scores are further adjusted to a standardized TMB score by alignment to commercially available reference standards.
Standardized TMB scores are categorized as follows: TMB Low (< 10 mut/Mb) and TMB High (≥ 10 mut/Mb).
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 unresectable or metastatic solid tumors with TMB greater than or equal to 10 Muts/Mb that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Performing Laboratory
med fusion
