title: 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.
abstract: 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.
authors.affiliation: New York University School of Medicine, New York, NY Joseph.Ladapo@nyumc.org.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Ladapo
authors.affiliation: Comprehensive Health Insights, A Humana Company, Louisville, KY.
authors.forename: Heather
authors.initials: H
authors.lastname: Lyons
authors.affiliation: CardioDx, Inc, Palo Alto, CA.
authors.forename: May
authors.initials: M
authors.lastname: Yau
authors.affiliation: Comprehensive Physician Associates, Youngstown, OH.
authors.forename: Paul
authors.initials: P
authors.lastname: Rich
authors.affiliation: Maringouin Medical Center, Maringouin, LA.
authors.forename: Dedra
authors.initials: D
authors.lastname: Newton
authors.affiliation: Triangle Primary Care Associates, Wake Forest, NC.
authors.forename: Kofi
authors.initials: K
authors.lastname: Bruce-Mensah
authors.affiliation: CardioDx, Inc, Palo Alto, CA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Johnson
authors.affiliation: Comprehensive Health Insights, A Humana Company, Louisville, KY.
authors.forename: Yunping
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Comprehensive Health Insights, A Humana Company, Louisville, KY.
authors.forename: Stephen
authors.initials: S
authors.lastname: Stemkowski
authors.affiliation: CardioDx, Inc, Palo Alto, CA.
authors.forename: Mark
authors.initials: M
authors.lastname: Monane
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002637:Chest Pain / Q000175:diagnosis* / Q000235:genetics*; D005820:Genetic Testing; D023281:Genomics; D006801:Humans; D008875:Middle Aged; D057285:Precision Medicine; D011320:Primary Health Care; D011446:Prospective Studies
keywords: coronary artery disease; gene expression score; medical decision making; personalized medicine; registry