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GTR Home > Tests > NGS Oncology Melanoma Profile (Tissue Only)

Overview

Test order codeHelp: 72070

Test name

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NGS Oncology Melanoma Profile (Tissue Only) (NGS Oncology Melanoma)

Purpose of the test

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This is a clinical test intended for Help: Predictive

Condition

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Click Indication tab for more information.

How to order

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Preferred: Formalin-Fixed Paraffin Embedded Tissue (FFPE) block; Other accept: 10 unstained slides, 9 micron thick x 0.63 cubic mm; Spec stability: Ambient: Paraffin Embedded Tissue: 7 Days, Paraffin Block: 5 Years
Order URL Help: https://dlslab.com/services/precision-medicine-program/

Specimen source

8 unstained slides, 8 micron thick x 0.63 cubic mm
Paraffin block

Methodology

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Molecular Genetics
CSequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
  • NextSeq 550
  • TruSight Oncology 500

Summary of what is tested

Click Methodology tab for more information.

Clinical utility

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Guidance for selecting a drug therapy and/or dose

Clinical validity

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NGS comprehensive tumor profiling for melanoma performed by Diagnostic Laboratory Services is a next-generation sequencing assay able to identify known single nucleotide polymorphisms, copy number alterations, transcript fusion mutations, and microsatellite instability to determine matched FDA approved; NCCN guided therapy. Over the past 10 to 15 years, targeted agents have been a fundamental part of therapeutic decision-making. There has been a remarkable improvement in the overall survival of patients where there is a molecular target identified. In 2019, the impact trial was published in the Journal of hematology and oncology. Their look at 3487 patients who underwent tumor profiling showed statistically significant differences in response rate, progression-free survival, and overall survival in months at 3- years and 10- years. Approximately 300,000 patients underwent tumor profiling. At least one treatable molecular variant was found in 1307 patients, who eventually received an associated matched therapy. Objective response rates when there was a match were 16.4% versus 5.4% (p-value <0.0001). Median progression-free survival for matched and unmatched patients was 4.0 and 2.8 months (p-value <0.0001). Overall survival showed differences in matched and unmatched patients, 9.3 versus 7.3 months, with a 3- year survival rate of 15% in matched patients and 7% in unmatched patients. At 10 years, this survival rate was 6% versus 1% ( p-value <0.0001). In multivariate analysis, there was a shorter overall survival in patients with non-matched therapies (p-value <0.001).

Citations
  • Long-term overall survival and prognostic score predicting survival: the IMPACT study in precision medicine. - PubMed ID: 31888672
  • Molecular Landscape and Actionable Alterations in a Genomically Guided Cancer Clinical Trial: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH). - PubMed ID: 33048619

Test services

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  • Clinical Testing/Confirmation of Mutations Identified Previously, Order code: 72070, comments

Suggested reading

Practice guidelines

  • NICE, 2022
    UK NICE Guideline NG14, Melanoma: assessment and management, 2022

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