Over one-third of Caucasians and over 40% of patients of African and Asian ancestry harbor gain-of-function and loss-of-function 2C19 variants. These variants are linked to a higher risk of adverse events with certain drugs. The xTAG® CYP2C19 Kit v3 solution offers the ability to identify CYP2C19*2 and CYP2C19*3 variants, which together account for approximately 99% of Asian and 87% of Caucasians poor metabolizers.1
Products for diagnostic use are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.
Intended Use (US-IVD/CA-IVD): xTAG CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anti-coagulated whole blood samples. xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3, and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.
xTAG CYP2C19 Kit v3 is indicated for use with the Luminex® 100/200™ instrument or MAGPIX® with xPONENT™ software systems.
xTAG CYP2C19 Kit v3 is not indicated for stand-alone diagnostic purposes. The information provided from this test may supplement decision making and should only be used in conjunction with routine monitoring by a physician. Because of the variability in the knowledge of clinical utility with specific drugs that are metabolized by CYP2C19, clinicians should use professional judgment in the interpretation of results from this test. Results from this type of assay should not be used in predicting a patient’s response to drugs for which the drug metabolizing enzyme activity of that allele, or the drug metabolic pathway, has not been clearly established.