[NMPA News] Zeesan MeltPro®HLA-B*58:01 gene detection kit successfully receives certification


November 12, 2021, Zeesan Biotech’s HLA-B*58:01 gene detection kit (fluorescence PCR melting curve analysis) successfully received certification from NMPA (GXZZ 20213400934) after HLA-B*15:02 gene detection kit. Based on multicolor melting curve analysis (MMCA®), the kit is used for in vitro qualitative detection of HLA-B*58:01 gene, which can guide discreet use of allopurinol by population carries HLA-B*58:01 gene and avoid severe dermal toxicity reaction.



HLA-B*58:01 gene


HLA-B*58:01 is a HLA allele, and patients carrying HLA-B*58:01 allele are more frequently found among indigenous people of Africa, Asia (such as the Han Nationality, Korea and Thailand) and Hawaii [1]. In certain regions of China, positive rate of HLA-B*58:01 is up to 22% [2].



Guidance of HLA-B*58:01 for clinical medication


FDA-approved allopurinol labeling advice: detection of HLA-B*58:01 shall be conducted among population with genetic risks, and the statement of HLA-B*58:01 positive patients are not recommended to use allopurinol unless benefits overweigh risks shall be made.


CPIC takes HLA-B*58; 01 as Class 1A pharmacogenomic marker for prediction of dermal toxicity of allopurinol.


The “Summary of Technical Guidelines for Genetic Testing of Drug Metabolizing Enzymes and Drug Action Targets (for Trial)” released by the National Health Commission  in 2015 clearly states that allopurinol should be used with caution in those carrying the HLA-B*58;01 allele.


*CPIC – Clinical Pharmacogenetics Implementation Consortium



Zeesan Biotech MeltPro®HLA-B*58:01 Gene Detection Kit


Feature 1 – Single-tube reaction reagent based on melting curve technique

  • Reduction in sample adding times
  • 96-well PCR system can realize 94 samples/batch


Feature 2 – Powder reagent boasts of convenient transport, storage and operation

  • It can be transported under normal temperature (<37 ℃) and stored in refrigerator (<8 ℃)
  • It doesn’t need liquid preparation operation, and sample can be added directly after opening the cap, which makes it easier to operate


Feature 3 – Applicable to the two application scenarios of batch testing and POCT

  • Batch testing by MeltPro system

Testing time: 3.5h; sample type: EDTA anticoagulant

  • POCT by SANITY system

Testing time: 2h; sample type: saliva



 Zeesan Biotech’s complete set of drug related gene detection solutions


No. Product name Test site and clinical significance Product status


MeltPro®ALDH2Test(fluorescence PCR melting curve analysis) Patients with angina pectoris who carry ALDH2*2 allele shall switch to other emergency medicines to avoid ineffective sublingual administration of nitroglycerin.It can be not only used for treatment and prevention of coronary heart disease and angina pectoris, but also used for reduction of blood pressure or treatment of congestive heart failure




MeltPro®CYP2C19 Test(fluorescence PCR melting curve analysis) 1. Clopidogrel, which’s used for improvement of coronary heart disease and angina pectoris2. Mephenytoin, which’s used for treatment of epileptic seizure

3. Omeprazole, which’s used for treatment of gastric ulcer, duodenal ulcer, stress ulcer, reflux esophagitis and Zollinger-Ellison syndrome (gastrinoma)

4. Tranquillizer, which’s used for treatment of insomnia and epilepsy




MeltPro®CYP2C19 & VKORC1 Test(fluorescence PCR melting curve analysis) 1. Substitute CYP2C9 and VKORC1 genotypes into Warfarin (thrombus and myocardial infarction) dosage calculation formula to calculate initial dosage;2. Reduce dosage of Celecoxib for individuals carrying CYP2C9*3; (Celecoxib capsule is mostly used for mitigation of osteoarthritis, rheumatoid arthritis in adults, acute pain in adults as well as symptoms and signs of ankylosing spondylitis in clinical applications)

3. Properly increase dosage of Losartan (hypotensor) for hypotension patients carrying CYP2C9*3 allele.




MeltPro®HLA-B*15:02Test(fluorescence PCR melting curve analysis) People carry HLA-B*1502 allele shall be discreet in use of Carbamazepine and PhenytoinCarbamazepine is used against epilepsy, neuropathic pain, anxiety and depression




MeltPro®MTHFR Test(fluorescence PCR melting curve analysis) MTHFR C677T, detection of folate metabolismPreventive medication to women in pregnancy and lactation period; prevention of stroke of hypertension patients




MeltPro®HLA-B*58:01 Test(fluorescence PCR melting curve analysis) People carry HLA-B*5801 allele shall be discreet in use of allopurinolAllopurinol has the efficacies of reduction in production of uric acid through inhibition of xanthine oxidase




MeltPro®NAT2 Test(fluorescence PCR melting curve analysis) Patients with slow metabolism type genotype of NAT1 and NAT2 can easily have cumulative poisoning upon repeated medication of isoniazid, which can give rise to peripheral neuritisIsoniazide is an important antituberculous drug used at themoment, which has highly selective antibacterial activity against mycobacterium tuberculosis and affects synthesis of its cell wall

Under application for registration

[1] Pharmaceutical Knowledge Base https://www.pharmgkb.org/

[2] Analysis on HLA-B*58:01 gene frequency among population in southern Fujian



  • captcha