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By performing Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS) and IHC analysis, Caris Life Sciences’ comprehensive profiling addresses the recommendations from ASCO’s Provisional Clinical Opinion.*
Somatic Genomic Testing in Patients with Metastatic or Advanced Cancer: ASCO Provisional Clinical Opinion
Journal of Clinical Oncology, February 2022
Precision oncology is a rapidly emerging discipline with dozens of biomarker-associated drug approvals each year and many clinical trials leveraging next-generation sequencing (NGS) for patient eligibility. The American Society of Clinical Oncology (ASCO) convened an expert panel to provide recommendations on genomic sequencing to guide treatment selection in metastatic or advanced cancer. The ASCO panel’s 2022 published recommendations are summarized herein.
PCO 1.1: General Genomic Testing Guidance
Genomic testing should be performed for patients with metastatic or advanced cancer if there are genomic biomarker-linked approved therapies or contraindications.
PCO 1.2.1 – 1.2.2: Multigene Panels
Multigene genomic testing is preferred over single-gene testing if there are one or more genomic biomarker-linked approved therapies.
PCO 1.3: Quality Standard Requirements
If the genomic sequencing results are used to inform clinical care, such testing must be performed in an appropriately certified laboratory.
PCO 2.1 – 2.2: Immunotherapy
When evaluating patients for immunotherapy, dMMR, MSI, and TMB may be evaluated with genomic testing. With TMB, testing should be performed with either large multigene panels with validated TMB testing or whole exome analysis.
PCO 3.1 – 3.3: Fusions and Exon Skipping
Fusion testing should be performed for disease-specific therapies, or NTRK fusion testing for broader TRK-inhibitor therapy. Genomic testing for MET exon 14 skipping in NSCLC patients should also be performed.
Multigene panel testing should be considered to determine candidacy for tumor-agnostic therapies (tests such as TMB-H, dMMR, MSI or NTRK fusions) and for clinical trial matching.
Caris Comprehensive Profiling Meets ASCO Recommendations
By performing Whole Exome Sequencing, Whole Transcriptome Sequencing and IHC analysis, Caris Life Sciences’ comprehensive profiling addresses the recommendations from ASCO’s Provisional Clinical Opinion.
(Mutations, Indels & Copy Number Alterations)
(Fusions & Variant Transcripts)
Genomic testing should be performed for patients with metastatic or advanced solid tumors with adequate performance status.
Caris performs genomic testing, plus IHCs if requested, for all patients.
For patients with metastatic or advanced solid tumors, genomic testing using multigene genomic sequencing is preferred whenever patients are eligible for a genomic biomarker–linked therapy that a regulatory agency has approved.
Caris provides the most comprehensive multi-gene genomic testing with every order.
DNA: Whole Exome Sequencing (22,000 genes)
RNA: Whole Transcriptome Sequencing (22,000 genes)
Multigene panel–based genomic testing should be used whenever more than one genomic biomarker is linked to a regulatory agency–approved therapy.
If the genomic sequencing results are used to inform clinical care, such testing must be performed in an appropriately certified laboratory.
Caris meets quality standards, including CLIA, CAP, ISO and NY DOH.
Clinical decision making should incorporate (1) the known or predicted impact of a specific genomic alteration on protein expression or function and (2) clinical data on the efficacy of targeting that genomic alteration with a particular agent.
Caris reports include details of the biomarkers reported and biomarkertherapy clinical data.
Mismatch repair deficiency status (dMMR) should be evaluated on patients with metastatic or advanced solid tumors who are candidates for immunotherapy. There are multiple approaches, including using large multigene panel-based testing to assess microsatellite instability (MSI). Consider the prevalence of dMMR and/or MSI-H status in individual tumor types when making this decision.
Caris tests for both MMR through IHC testing and MSI through Whole Exome Sequencing.
Mismatch Repair (MMR) proteins: MLH1, MSH2, MSH6, PMS2
Microsatellite Instability (MSI): Whole Exome Sequencing (22,000 genes)
When TMB may influence the decision to use immunotherapy, testing should be performed with either large multigene panels with validated TMB testing or whole-exome analysis.
Caris evaluates Tumor Mutational Burden (TMB) via Whole Exome Sequencing for every order.
In patients with metastatic or advanced solid tumors, fusion testing should be performed if there are fusion-targeted therapies with regulatory approval for that specific disease.
Caris tests for fusions, including NTRK fusions, with Whole Transcriptome Sequencing (RNA) for every order.
“RNA-based approaches avoid the challenges of sequencing through introns required by DNA methods and are superior, in general, for detecting expressed fusions.”
NTRK fusion testing should be performed in patients with metastatic or advanced solid tumors who may be candidates for TRK-inhibitor therapy, considering the prevalence of NTRK fusions in individual tumor type.
Testing for other fusions is recommended in patients with metastatic or advanced solid tumors if no oncogenic driver alterations are identified on large panel DNA sequencing.
Testing for MET exon 14 skipping should be performed for patients with all types of non–small-cell lung cancer.
Caris tests for MET exon 14 skipping via Whole Transcriptome Sequencing (RNA) for all solid tumors, including NSCLC patients.
Genomic testing should be considered to determine candidacy for tumoragnostic therapies in patients with metastatic or advanced solid tumors without approved genomic biomarker–linked therapies.
Caris tests for biomarkers linked to tumor-agnostic FDA approvals, such as pembrolizumab for dMMR, MSI-H, and TMB-H solid tumors; and larotrectinib and entrectinib for NTRK fusion positive tumors.
For tumors with actionable genomic alterations without approved genomic biomarker–linked targeted therapies, patient participation in clinical trials is encouraged after considering the expected efficacy of available standard-of-care options.
Caris includes clinical trial opportunities with every order.
Clinical Trials Solutions™ (Right in Time)
Off-label and off-study use of genomic biomarker–linked therapies approved in other diseases is not recommended when a clinical trial is available or without clinical evidence of meaningful efficacy.
Chakravarty D, Johnson A, Sklar J, Lindeman NI, Moore K, Ganesan S, Lovly CM, Perlmutter J, Gray SW, Hwang J, Lieu C, André F, Azad N, Borad M, Tafe L, Messersmith H, Robson M, Meric-Bernstam F. Somatic Genomic Testing in Patients With Metastatic or Advanced Cancer: ASCO Provisional Clinical Opinion. J Clin Oncol. 2022 Feb 17:JCO2102767. doi: 10.1200/JCO.21.02767. Epub ahead of print. PMID: 35175857.
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