TY - JOUR T1 - Utility of a Genomic-based, Personalized Medicine Test in Patients Presenting With Symptoms Suggesting Coronary Artery Disease JF - The Journal of the American Board of Family Medicine JO - J Am Board Fam Med SP - 258 LP - 267 DO - 10.3122/jabfm.2014.02.130155 VL - 27 IS - 2 AU - Lee Herman AU - James Froelich AU - Dino Kanelos AU - Robert St. Amant AU - May Yau AU - Brian Rhees AU - Mark Monane AU - John McPherson Y1 - 2014/03/01 UR - http://www.jabfm.org/content/27/2/258.abstract N2 - 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. ER -