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Diagnosis
Provisional Clinical Opinions (PCOs)
Section 1: Multigene Panel-Based Genomic Sequencing with
Disease-Specific Approved Markers
PCO 1.1
➤ Genomic testing should be performed for patients with metastatic
or advanced solid tumors with adequate performance status in the
following two clinical scenarios:
• When there are genomic biomarker-linked therapies approved by regulatory
agencies for their cancer.
• When considering a treatment for which there are specific genomic biomarker-
based contraindications or exclusions. (Strong recommendation)
PCO 1.2.1
➤ 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. (Moderate recommendation)
PCO 1.2.1
➤ Multigene panel-based genomic testing should be used whenever
more than one genomic biomarker is linked to a regulatory agency-
approved therapy. (Strong recommendation)
PCO 1.3
➤ If the genomic sequencing results are used to inform clinical care,
such testing must be performed in an appropriately certified
laboratory. (Strong recommendation)
PCO 1.4
➤ 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. (Strong recommendation)
