Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test: results from a prospective registry study.

Novel approaches for assessing patients with chest pain and related symptoms may improve outpatient care. The REGISTRY I study measured the impact of a personalized gene expression score (GES) on subsequent cardiac referral decisions by primary care providers. Of the 342 stable, nonacute patients evaluated, the mean age was 55 years, 53% were female, and mean (SD) GES was 16 (±10) (range = 1-40). Low GES (≤15), indicating a low current likelihood of obstructive coronary artery disease (CAD), was observed in 49% of patients. After clinical covariate adjustment, each 10-point GES decrease was associated with a 14-fold decreased odds of cardiac referral (P < .0001). Low GES patients had 94% reduced odds of referral relative to elevated GES patients (P < .0001), with follow-up supporting a favorable safety profile. This genomic-based test demonstrated clinical utility by guiding decision making during assessment of symptomatic patients with suspected obstructive CAD.