CYP2C19 Assay


  • The INFINITI CYP2C19 Assay is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). 
  • The INFINITI CYP2C19 Assay is indicated for use as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP450 2C19 gene product.
  • The INFINITI CYP2C19 Assay is not indicated to be used to predict drug response or non-response.
  • The INFINITI CYP2C19 is available in Single and QUAD formats.
  • The INFINITI CYP2C19 Assay utilizes the CYP2C19 Intellipac™, CYP2C19 Amp Mix and CYP2C19 BioFlimChip™ Microarray.
  • The INFINITI CYP2C19 Assay is automated by the INFINITI Analyzer.

Analytes Detected: 

  • CYP450 2C19: *2, *3, *17


  • 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: 

  • Genetic polymorphisms in CYP2C19 are common and can affect therapeutic response to drugs; ranging from poor metabolizers to ultra-rapid metabolizers.1
  • The most common poor metabolizer phenotypes have been identified as CYP2C19*2 and CYP2C19*3.1
  • CYP2C19*17 is the one phenotype that has an opposite effect. CYP2C19*17 has been reported to be associated with ultra-rapid CYP2C19 activity.2,3

Clinical Utility: 

  • CYP2C19 is involved in the metabolism and elimination of many commonly prescribed drugs including antidepressants, anti-epileptics, barbiturates, and proton inhibitors.1
  • Detecting genetic variations in drug-metabolizing enzymes is useful for identifying individuals who may experience adverse drug reactions with conventional doses of certain medications.2
  • Adjustment of therapeutic strategy could be beneficial based upon knowledge of these differences in metabolism.3


  1. Desta Z et al Clinical Significance of the cytochrome P450 2C19 polymorphism. Clin Pharmacokinet 2002; 41:913-58
  2. Sim SC et al A common novel CYP2C19 gene variant causes ultra-rapid drug metabolism relevant for the drug response to proton pump inhibitors and anti-depressents. Clin Pharmacol Ther. 2006; 79:103-113
  3. Rudberg l et al Impact of the ultrarapid CYP2C19*17 allele on serum concentration of escitalopram in psychiatric patients. Clin Pharmacol Ther. 2008 Feb;83(2):322-7

To obtain the IFU for this application, please Click Here.

For more product information please Contact Us.