【Great news】Zeesan’s MeltPro® HLA-B*15:02 Test Is Approved By NMPA

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On September 18, 2021, Zeesan’s MeltPro® HLA-B*15:02 Test received GXZZ 20213400740 certificate from NMPA. The multicolor melting curve analysis-based (MMCA®) test kit is used for determination of whether a patient carries HLA-B*15:02 gene through in vitro qualitative test, and population carrying HLA-B*15:02 gene shall use Carbamazepine with caution to avoid serious toxic reaction of skin.

What is HLA-B*1502

As an expression of major histocompatibility complex, human leukocyte antigen (HLA) is mainly responsible for cell recognition and induction of immune responses in immune system as well as modulation of the immune response. As an allele of HLA, HLA-B*15:02 almost only exists in Asians. China, Thailand, Malaysia, Indonesia, Philippines, and Taiwan Region are expected to have 10-15% and even more patients carrying the allele of HLA-B*15:02¹.

Guidance on clinical medicaiton of patients carrying HLA-B*1502 gene

According to PharmGKB, the international pharmacogenetics and pharmacogenomics database: to patients carrying the allele of HLA-B*15:02, carbamazepine, oxcarbazepine, phenytoin and other drugs have clinical evidence for the highest Grade 1A toxicity.

FDA warns clinicians to pay attention to recommendations in package insert of carbamazepine, patients who may carry the allele of HLA-B*15:02 shall have screening for the allele of HLA-B*15:02 before receiving carbamazepine therapy, and patients have positive screening results are not suitable to use carbamazepine unless benefits significantly overweigh risks².

As early as 2015, National Health Commission also explicitly pointed out in Summary of Technical Guidelines (Trial) for Target Gene Test of Drug Metabolism Enzyme and Drug Action that patients carrying the allele of HLA-B*15:02 shall use carbamazepine and phenytoin with caution³.

PharmGkb – an international pharmacogenetics database sponsored by National Institute of Health (NIH), which’s the most comprehensive and useful database in study of pharmacogenomics at the moment.

Zeesan’s HLA-B*15:02 gene assay kit

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MMCA-based single-tube reaction reagent

◆ Reduction in sample adding times

◆ 96-well PCR instrument can achieve 94 samples / batch

Lyophilized reagent easy to transport, store and operate

◆ It can be transported under normal temperatures (<37 ℃) and in refrigerator (<8 ℃)

◆No solution preparation, sample can be added directly after opening the lid, which is easier to operate

Suitable for two application scenarios of batch test and point of care test

◆ MeltPro® system for batch test

◆ Sanity® system for point of care test

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Sampling——20-minute extraction——3-hour test——Result analysis/ Report cycle of 3.5 hours

Sampling——Sample in, result out/ Report cycle of 1.5-2.0 hours

 

Other star products from Zeesan’s personalized medication pipeline

In addition MeltPro® HLA-B*15:02 Test, Zeesan also provides MeltPro® ALDH2 Test for guidance on use of glonoine, MeltPro® CYP2C19 Test for guidance on use of Clopidogrel, MeltPro® MTHFR&MTRR Test for guidance on personalized folic acid supplementation, MeltPro® HLA-B*58:01 Test for guidance on use of Allopurinol, MeltPro® CYP2C9 & VKORC1 Test for guidance on use of Warfarin and MeltPro® NAT2 Test for guidance on use of isoniazide, which can meet diversified clinical personalized medication needs.

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1,2 , US Warns that Patients Carrying aAllele of HLA-B*1502 May Have Serious Skin Reactions – (medlive.cn)

3. Prac J OrganTransplant ( Electronic Version ), September 2015 , Vol.3 , No.5


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