Warfarin Assay

INFINITI Warfarin Assay (IVD)

  • The INFINITI Warfarin Assay is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).
  • The INFINITI Warfarin Assay is indicated for use to identify individuals at risk for sensitivity to Warfarin.
  • The INFINITI Warfarin Assay utilizes the Warfarin Assay Intellipac, Warfarin Assay Amp Mix and Warfarin Assay BioFlimChip Microarray.
  • The INFINITI Warfarin Assay is automated by the INFINITI Analyzer.

Analytes Detected: 

  • CYP450 2C9: *2, *3
  • Clinical Relevance: *2, *3 are the commonly identified 2C9 variants shown to decrease enzymatic activity.
  • VKORC1: 3673 (-1639G>A)
  • Clinical Relevance: 3673 = (-1639G>A) is the commonly identified VKORC1 variant and could be predictive of an individual’s response to Warfarin.


  • Multiplexed determination of 3 genetic variants.
  • Rapid turnaround time enhances workflow efficiency.
  • Load & Go automated on the INFINITI/INFINITI PLUS Analyzer.
  • Replicate determinations on a single BioFilmChip Microarray ensures quality results.

Sample Type and Volume: 

  • Uses 0.2 – 2.0 mL of peripheral whole blood in EDTA (purple top) tube.
  • Requires 50 ng DNA / reaction

Clinical Relevance: 

  • Warfarin is the most widely prescribed oral anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors.
  • Warfarin is used to treat various disorders, including venous thrombosis, atrial fibrillation, pulmonary embolism, acute myocardial infarction and following heart valve replacement.
  • In the US, more than 3,000,000 new prescriptions are being written every year, and the total number of warfarin prescriptions has increased by 45 percent between 1999 and 2004.1
  • There is greater than a ten-fold interpatient variability in the response to Warfarin.1

Clinical Utility: 

  • Warfarin exposes patients to increased risk of hemorrhage.
  • Annual incidence of associated major-bleeding complications has ranged from 1.0% to 5.0%.1
  • Annual incidence of fatal hemorrhages has been reported as 0.5% to 1.1%. 1
  • Major bleeding occurred during the first 90 days of treatment in 50% of patients.1 
  • Adverse effects of warfarin treatment account for 15 percent of all severe adverse effects.1


  1. Fanikos, John, et. al. Major bleeding complications in a specialized anticoagulation service. American Journal of Cardiology. 2005; 96: 595-98.

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