The CYP2C9 and VKORC1 Gene MCA Real-time PCR Kit (fluorescent PCR melting curve method) independently developed by Hybribio has officially obtained the registration certificate of Class III medical device (Registration Certificate No.: GXZZ 20243400054) issued by the National Medical Products Administration (NMPA).

The reagent is intended for dosing guidance of warfarin drug. Warfarin is the most widely used oral anticoagulant in clinical practice, and is widely used in the treatment of chronic atrial fibrillation (AF), valvular disease, prosthetic valve replacement and intracavitary thrombosis after prosthetic heart valve replacement, venous thrombosis and pulmonary embolism. The clinical efficacy and adverse effects of warfarin vary widely between races and individuals. Thus, the dosage is difficult to control, especially at the initial stage of anticoagulant therapy with warfarin, which is very likely to lead to severe bleeding complications.

Recent studies have found that genetic factors are the main reason for individual differences in warfarin dosage, and that polymorphisms in the VK0RC1 gene related to warfarin's mechanism of action and the CYP2C9 gene related to warfarin's metabolism are closely related to its anticoagulant efficacy.

Warfarin is mainly metabolized by cytochrome 2C9 (CYP2C9), and vitamin K epoxide reductase (VKORC1) is the target of warfarin action. Pharmacogenomic studies have shown that there are many genetic polymorphisms in the VKORC1 and CYP2C9 genes that affect warfarin metabolism and play a key role in individual differences in warfarin dose. The warfarin dose required to achieve the same anticoagulant effect in patients with different types of metabolism of the two genes can vary up to 20-fold between individuals.

The Chinese Expert Consensus on Warfarin Anticoagulation Therapy released in 2013 suggests that genetic testing can be used to determine the initial dose selection, and that the patient's body surface area, liver and kidney function, and comorbidities should also be taken into account, and that genetic testing can be used for warfarin dose adjustment if available.

The CYP2C9 and VKORC1 Gene MCA Real-time PCR Kit independently developed by Hybribio Biotech cover the CYP2C9 and VKORC1 gene polymorphism analysis sites recommended by the Chinese Expert Consensus on Warfarin Anticoagulation Therapy, and based on the fluorescent PCR melting curve technology, they can qualitatively detect the CYP2C9 gene, CYP2C9c.1075 A＞C, CYP2C9c.430 C＞T locus and VKORC1 c.-1639 G＞A locus in human venous whole blood samples, so as to assist doctors in the scientific administration of warfarin, predict the tolerated dose of warfarin in patients, reduce the risk of hemorrhage and thrombosis, and shorten the time for patients to reach the stable value of the drug.

Hybribio, as a leading enterprise in molecular diagnosis, has developed a series of reagents covering HPV testing, reproductive tract health, birth defects, respiratory infectious disease, cancer methylation and other products. The CYP2C9 and VKORC1 Gene MCA Real-time PCR Kit diversify Hybribio's product lines of pharmacogenomics.

CYP2C9 and VKORC1 Gene MCA Real-time PCR Kit

(Fluorescent PCR melting curve method)

Product Feature

(1) High sensitivity and specificity

Adopting fluorescent PCR melting curve technology, the analytical sensitivity is up to 5ng/µL and the analytical specificity is 100%;

(2) Single-tube amplification & High throughput

One single tube can detect 3 SNP sites of 2 genes (CYP2C9*2, CYP2C9*3, VKORC1-1639), and can detect 96 human samples in the same run;

(3) High automation

Compatible to common fluorescent PCR, it can achieve real-time monitoring and automatic reading; With Hybribio automated extraction instrument, one experiment only takes 2.5 hours.

(4) Open platform

Hybribio's pharmacogenetic products include warfarin, clopidogrel, statin, folic acid, nitroglycerin, all using the same testing platform and testing procedures;

(5) Anti-contamination

Amplification and detection are performed in a closed system, which improve the level of anti-contamination.

(6) Compatible instrument

It is compatible to fluorescent PCR instruments that can perform melting curve analysis.

(7) Target population

Patients who are taking warfarin or will be taking warfarin and need long-term anticoagulation, including patients with venous thrombosis, thromboprophylaxis for patients with heart valve disease, patients with pulmonary embolism, patients with thromboembolic disease, thromboprophylaxis for patients with atrial fibrillation, etc.