In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents XXII

3.5 Pharmacogenomics Molecular Diagnostic Reagent

Systemic lupus erythematosus (SLE) is the most common systemic autoimmune disease in China, with an incidence of 30.13–70.41/100000 population. The kidney is the most commonly involved organ in SLE, and 40% ~ 60% of SLE patients have lupus nephritis (LN). In China, nearly half of SLE patients are complicated with lupus nephritis. There is increasing evidence showing that tacrolimus (also known as FK506) has good efficacy and safety in lupus nephritis.

In 2015, the Clinical Pharmacogenomics Implementation Consortium published guidelines on the CYP3A5 genotype and tacrolimus dose for patients with CYP3A5*1/CYP3A5*1, CYP3A5*1/CYP3A5*3, CYP3A5*1/CYP3A5*6, and CYP3A5*1/CYP3A5*7 genotype; it is recommended to use 1.5–2 times of the standard dose as the initial dose. The main alleles in the Asian population are CYP3A5*1 (25.8%) and CYP3A5*3 (74.2%). Therefore, the Outline of Technical Guidelines for Gene Detection of Drug Metabolism Enzymes and Drug Action Targets (Trial) also recommends reducing the dose of tacrolimus in CYP3A5*3/*3 genotype patients to avoid adverse reactions.

Although there is a slight difference in methodology, both CYP3A5 (A6986G) Gene Detection Kit (Registration No.: G.X.Z.Z. 20,193,400,286) developed by Shanghai BaiO Technology Co., Ltd. and Human CYP3A5 Genotyping Detection Kit (Fluorescence-PCR Method) (Registration No.: G.X.Z.Z. 20,203,400,784) developed by Hangzhou KBM Life sciences Co., Ltd. will play a role in the precise drug use of tacrolimus in the treatment of lupus nephritis.

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