Vizient PrecisionCHD™

0020714

PKCHD

Ordering Recommendation

For the detection and management of coronary heart disease. Rx only.

Methodology

An integrated epigenetic-genetic test to aid in diagnosing and managing coronary heart disease was developed using data from subjects from the Framingham Heart Study and validated using data from subjects from the Intermountain Healthcare INSPIRE registry and University of Iowa Hospitals and Clinics.

Performed

Monday-Friday

Reported

Within 7-10 business days of receiving the blood sample

Geographic Restrictions

This test is not eligible to be performed in patients from New York

Specimen Required

Patient Preparation:

Collect: 2 mL blood sample (vacutainer) or 500uL (microtainer)

Specimen Preparation: 2mL BD K2EDTA vacutainer or 500uL BD K2EDTA microtainer and lancet

Storage/Transport Temperature: Room temperature

Unacceptable Conditions: Specimen must be shipped the same day of collection. Delayed shipment of the specimen may result in the specimen being rejected.

Remarks: Specimen collection information and a test requisition form must be provided

Interpretive Data

A positive coronary heart disease detection result represents that signal associated with coronary heart disease was detected in the analysis of the patient’s 10 single nucleotide polymorphisms (SNPs) and 6 DNA methylation biomarkers. A positive coronary heart disease signal is not a diagnosis of coronary heart disease and should only be used in combination with a comprehensive medical evaluation by a trained clinician. Additional diagnostic evaluation for coronary heart disease should be performed as per clinical guidelines. A negative coronary heart disease detection result represents that signal associated with coronary heart disease was not detected in the analysis of the patient’s 10 single nucleotide polymorphisms (SNPs) and 6 DNA methylation biomarkers. A negative coronary heart disease signal does not imply the absence of a coronary heart disease diagnosis and should be used only in combination with a comprehensive medical evaluation by a trained clinician. Additional diagnostic evaluation for coronary heart disease should be performed as per clinical guidelines. PrecisionCHD™ is a Laboratory Developed Test (LDT).