Clinical Utility Evaluations

Clinical Utility Evaluations are comprehensive health technology assessments for complex genetic disorders and syndromes, which evaluate the impact of genetic testing on patient outcomes, diagnostic thinking, clinical decision making, and family members. These reports include the Hayes Clinical Utility Score, an overall rating of the strength and direction of the body of evidence for clinical utility of genetic testing for a specific indication.

Clinical Utility Evaluations provide evidence-based support for the development of coverage policy, utilization management, and evidence-based clinical practices. Used in conjunction with our Laboratory Insights database, these reports provide the critical evidence context to make decisions around multi-gene panel tests. Reports are reviewed annually up to 5 years post publication to determine if there is new literature or evidence that would impact a change in rating and warrant an updated report.

MTHFR Genetic Testing for Severe MTHFR Enzyme Deficiency

This report evaluates the clinical utility of methylenetetrahydrofolate reductase (MTHFR) genotyping in pediatric or adult patients to detect rare variants associated with severe MTHFR enzyme deficiency for the purpose of informing treatment or family-planning decisions.

Pharmacogenomic Testing of Selected Mental Health Conditions

This report evaluates the clinical utility of pharmacogenomic testing to inform the selection or dose of medications for individuals diagnosed with depression, bipolar disorder, schizophrenia spectrum or other psychotic disorder, or anxiety disorder to improve clinical outcomes.