Utility of a genomic-based,personalized medicine test in patients presenting with symptoms suggesting coronary artery disease

Purpose: better methods are needed to assess patients presenting with symptoms suggestive of obstructive coronary artery disease (cad). we hypothesized that the use of a gene expression score (ges) would lead to a change in the diagnostic evaluation. methods: the primary care providers use of a gene expression test in coronary artery disease diagnosis (impact-pcp) trial (clinical trial identifier nct01594411,clinicaltrials.gov) was a prospective study of stable,nonacute,nondiabetic patients presenting with chest pain and related symptoms at 4 primary care practices. all patients underwent ges testing,with clinicians documenting their planned diagnostic strategy both before and after ges. the ges was derived from a peripheral blood draw measuring expression of 23 genes and has been shown to have a 96% negative predictive value for excluding the diagnosis of obstructive cad. results: of the 251 study patients,140 were women (56%); the participants had a mean age of 56 years (standard deviation,13.0) and a mean body mass index of 30 mg/kg2 (standard deviation,6.7). the mean ges was 16 (range,1-38),and 127 patients (51%) had a low ges ([ltqeu]15). a change in the diagnostic testing pattern before and after ges testing was noted in 145 of 251 patients (58% observed vs. 10% predefined expected change; p < .001). conclusions: incorporation of the ges into the diagnostic workup showed clinical utility above and beyond conventional clinical factors by optimizing the patient's diagnostic evaluation.