Prioritizing genomic applications for action by level of evidence: a horizon-scanning method

Abstract

As evidence accumulates on the use of genomic tests and other health-related applications of genomic technologies, decision makers may increasingly seek support in identifying which applications have sufficiently robust evidence to suggest they might be considered for action. As an interim working process to provide such support, we developed a horizon-scanning method that assigns genomic applications to tiers defined by availability of synthesized evidence. We illustrate an application of the method to pharmacogenomics tests.

Figure 1

Method for classification of genomic applications by levels of evidence for implementation. The list is read from top to bottom to determine whether a genomic test meets any of the criteria for each of the three color-coded categories or tiers. The listing of criteria should be viewed as “OR” statements, so only one criterion needs to be met for categorization. CMS, Centers for Medicare & Medicaid Services; FDA, US Food and Drug Administration.