According to Annual Report for National Adverse Drug Reactions Monitoring (2018), the National Adverse Drug Reaction Monitoring Network received 1.499 million copies of the Adverse Drug Reaction/Event Reporting Form [1]. The National ADR Monitoring Network cumulatively received 13.68 million copies of the Adverse Drug Reaction/Event Reporting Form between 1999 and 2018[2]. The annual amount of increase in medical expenses due to ADRs was up to RMB 4 billion in China, the number of inpatients due to ADRs accounted for 5% of the total number of inpatients, and the number of direct deaths reached 200,000[3].
Pharmacogenomics
Pharmacogenomics is a discipline that studies the impacts of congenital or acquired genetic variations a patient carries on drug action through associating gene expressions or single nucleotide polymorphism (SNP) with drug ADEM （absorption, distribution, metabolism, excretion）and drug targets (receptors) [4].
Pharmacogenomics’ guidance on individualized medication
Pharmacogenomics uses genomics information to interpret differences in drug action on individuals, and guides new drug development and realizes individualized medication on this basis.
Pharmacogenomics’ guidance on individualized medication is mainly reflected by:
1) Prediction of (targets’) drug sensitivity – prediction of efficacy
2) Prediction of (metabolism enzymes’ and transporters’) metabolic rate of drug – prediction of dosage
3) Prediction of adverse drug reactions – avoidance of ADRs of drugs
Gene polymorphism determines differences in drug effects on individuals
Single nucleotide polymorphism (SNP) refers to changes in the DNA sequence due to changes in single nucleotide of A, T, C and G. 90% of human variations are caused by SNP, and drug related differences among individuals shall be analyzed from the perspective of SNP as well.
Drug related genes studied by Pharmacogenomics can be divided into four categories:
1) Enzyme involved in drug metabolism process;
2) Drug-receptor (target proteins);
3) Drug transport related channel (transport proteins);
4) Proteins involved in signal transduction.
Common pharmacogenetic testing platforms
Technical Guidelines on Genetic Testing Technologies Based on DMEs and Drug Action Targets (Trial) summarized strengths and weaknesses of certain existing pharmacogenetic testing platforms. The editor believes that pharmacogenetic tests shall choose the most suitable testing platform under existing conditions. Firstly, it shall pursue sensitivity and specificity of detection reagent, and make sure results are accurate and reliable; secondly, it shall take into consideration of the platform’s detection throughput and degree of automation; at last, reagent cost and human cost shall be also taken into consideration.
MMCA® – automatic, convenient and accurate pharmacogenetic testing platform
Multicolor Melting Curve Analysis technique – MMCA® is the unique innovative single tube multi-target fluorescence PCR test technique of Zeesan. It has received patents in China, US and four EU countries (UK, France, Germany and Netherlands).
Feature 1 – Higher throught
✔Single tube detection of up to 72 targets
✔Significant strength in the detection of multiple drug resistance genes and medication guidance genes
Feature 2 – Lower cost
✔Easy automation, which can save human cost
✔Lyophilized reagents, saving transportation and storage costs
Feature 3 – Better identification of specificity at SNP sites
✔LOD: 0.1ng/μL
✔MMCA can accurately identify SNP and better identify specificity by fluorescence and temperature dual-labeling
Zeesan’s complete set of pharmacogenetic testing solutions
1-2, Annual Report on Monitoring of National Adverse Drug Reactions (2018)
3, China Medicine, 2014, 9 (11), Research Progress of Individualized Medication
4, Application of pharmacogenomics in clinical medication, 1673-7806（2019）01-046-06