Biomarker Testing

一、Business Area




二、Business Details

1.Cardiovascular disease risk - TMAO testing
TMAO (trimethylamine N-oxide) is a metabolite of intestinal flora and an independent risk assessment factor for cardiovascular disease. It is closely related to chronic cardiovascular disease, diabetes, kidney injury, obesity, aging and memory impairment. The blood TMAO level can be utilized in the fields of health risk assessment, disease early warning, auxiliary diagnosis, individualized treatment and health care of general sub-health and high-risk groups.
Testing technology
Duxact has independently developed TMAO and its precursor testing technology, and has conducted in-depth cooperation with scientific research units such as Xiangya Hospital, The Third Xiangya Hospital, Renmin Hospital of Wuhan University, First Hospital of Changsha, General Hospital of Eastern Theater Command, etc., tested thousands of samples, and established a TMAO baseline for Chinese healthy populations. Duxact is the only company in Central and South China that has TMAO commercial testing capabilities. It has the first patent for TMAO testing technology in China, and has applied for dozens of TMAO related patents. Duxact also assists its clients to successfully obtain 2 National Natural Science Foundation of China and 1 local funded project.

2.Prediction of adverse drug reactions - Polygonum multiflorum susceptibility gene testing for liver injury
Changes in the coding gene sequence of drug metabolizing enzymes and drug targets can affect drug efficacy and safety, leading to individual differences. Pharmacogenomics research is helpful for clinical precision medicine and improves the efficiency of innovative drug research and development.
Testing technology
Based on the pharmacogenomics research platform, the Polygonum multiflorum susceptibility gene HLA-B*35:01 for liver injury was discovered for the first time. Related results were published in the international liver disease top journal Hepatology (impact factor 14.971), and 2 related patents have been applied, and 1 has been authorized. Also, Duxact has independently developed algorithms, with the help of AI technology (DHGP typing platform), and successfully established an HLA testing method, which realizes artificial intelligence analysis and automatic reporting of testing data to obtain testing results accurately and rapidly.
The system can not only rapidly and accurately test HLA-B*35:01, but also realize the testing of 7 major HLA gene loci. It can be used for prediction of 64 serious adverse drug reactions, diagnosis of genetic diseases, and organ transplantation matching testing.

3.Auxiliary diagnosis of rare diseases - genetic testing for rare diseases

Genetic testing for rare diseases
Rare diseases often have similar clinical features to other diseases. General examinations are difficult to determine the cause, and can lead to misdiagnosis and missed diagnosis and thus delay good treatment. Since rare diseases are mostly genetic diseases, they are caused by genetic defects. Therefore, genetic testing has become an important method for the diagnosis and prevention of rare diseases. It can provide an important reference for the clinical diagnosis of the disease, improve the diagnosis rate, shorten the diagnosis time, and reduce the diagnosis cost.

Testing Technology
Advantages of Sanger sequencing technology:

High accuracy 
Being capable of testing unknown mutations 
Being capable of testing long fragment insertion/deletion mutations
Testable diseases
Disease name  Tested target gene
Congenital adrenal dysplasia
Gaucher disease
Hepatolenticular degeneration
N-acetylglutamate synthase deficiency
Prader-Willi syndrome
Spinal muscular atrophy

4.Pathogenic microorganism detection - multiple detection of nucleic acids of 13 respiratory pathogens
Importance of diagnosis of viral etiology 
Type of detected pathogens 

Timely and effective antiviral treatment 
Prognosis assessment and management 
Avoid unnecessary antibiotic application and abuse 
Infection control
Detection process

Sample acceptance  Multiplex PCR capillary electrophoresis analysis

5.Auxiliary diagnosis of diabetes - glycated hemoglobin (mass spectrometry)
Glycated hemoglobin (GHb) is a main product of non-enzymatic reaction between hemoglobin in red blood cells and sugars (mainly glucose) in serum. GHb is present in the blood of patients with diabetes and hyperglycemia, and is closely related to blood glucose level. The plasma concentration of GHb is relatively stable in a short period of time, and is not affected by factors such as fasting or taking hypoglycemic drugs before the testing. It is a good indicator of the average blood glucose level in the past 4-8 weeks.

Importance of monitoring GHb
1.Auxiliary diagnosis of diabetes.
2.It is a diabetes progress monitoring indicator, and can be used to adjust treatment regime and identify potential risks.
3.Early diagnosis indicator for mild, type 2 and invisible diabetes.
4.Assess the risk of chronic complications of diabetes.
5.Prevent the occurrence and development of giant fetuses, malformed fetuses, stillbirths and acute and chronic complications in pregnant women with diabetes.

New glycated hemoglobin quantitative mass spectrometry system
The traditional detection of GHb is mainly immunoturbidimetric assay, enzymatic assay, latex agglutination assay, etc., which has the disadvantages of low sensitivity is low, obvious matrix interference, interference by variants. Clinical mass spectrometry represented by QuanTOF MS technology can overcome the shortcomings of traditional methods, and the detection results are more accurate.

6.Individualized administration for cardiovascular diseases - warfarin, clopidogrel

(1)Guide for individualized medication of warfarin
Warfarin is a first-line drug for the prevention and treatment of thromboembolic diseases, but its drug response varies greatly among individuals. The difference in stable doses of warfarin between individuals can reach more than 20 times, and the treatment window is narrow, and the dose is difficult to control, especially in the initial stage of anticoagulation treatment with warfarin, it is easy to cause serious bleeding complications. A large number of studies have shown that the pharmacokinetic process of warfarin is closely related to the genotypes of CYP2C9 and VKORC1. In 2010, the FDA added a starting dose selection table in the instructions for warfarin, suggesting that CYP2C9 and VKORC1 genetic testing should be performed before medication.
Other applicable fields of CYP2C19 genotyping test 
Non-steroidal anti-inflammatory drugs
Antidiabetic drugs

(2)Guide for individualized medication of clopidogrel
Clopidogrel is currently a widely used antiplatelet agglutinant for the treatment of cardiovascular diseases such as acute coronary syndrome and atherosclerosis. Clopidogrel is a prodrug, which can only exert its efficacy after being metabolized by liver cytochrome P450 enzymes (mainly CYP2C19 enzyme) into active products. Different individuals have different responses to clopidogrel. About 40% of Asian patients may develop clopidogrel resistance. The main reason is that CYP2C19 gene mutations lead to weak metabolism.
Other applicable fields of CYP2C19 genotyping test
Amitriptyline, etc.
Antiepileptic drugs:
Phenytoin, etc.
Anti-tumor drugs: