The 15th National Conference of laboratory medicine of the Chinese Medical Association (2019 National Conference of laboratory medicine for short) sponsored by the Chinese Medical Association and the laboratory branch of the Chinese Medical Association has come to a perfect end. The conference will cover the latest research results and development trends in various fields of clinical testing and laboratory management.

At this grand meeting of laboratory medicine, the world's first glycomics product, G-test oligosaccharide chain liver cancer early screening test, made its first public 'appearance'. We can see its 'magnificent' together.

Early diagnosis of liver cancer

China is a big country of hepatitis B and liver cancer, with a high incidence rate and high mortality.

China is a high incidence rate of hepatitis B, about 90 million of hepatitis B virus carriers, including 20 million cases of chronic hepatitis B, 466 thousand cases of hepatocellular carcinoma, 422 thousand cases died of HCC, and fourth of all cancers, third of deaths.

It is difficult to find in the early stage and becomes an important restricting factor in the prevention and treatment of liver cancer

Because liver cancer has no early symptoms, PET-CT and other imaging examinations, as well as the detection of tumor markers (such as AFP) have a high rate of early missed diagnosis, so it is very difficult to diagnose early cancer

The most effective way to prevent and treat liver cancer: early detection, early diagnosis and early treatment

The treatment of advanced liver cancer is very limited, with blood metastasis and tumor thrombus formation, the survival rate is very low. Therefore, we advocate early detection, early diagnosis and early treatment of liver cancer. High sensitivity detection methods are also urgently needed in clinical practice

• glycomics is a new subject after genomics and proteomics. It mainly studies the composition and function of sugar chains and is widely used in the research of new biomarkers. The cell surface is covered with various forms of sugar chains, which can help us identify cell types and states

• function of sugar chain

Intercellular recognition (cancer cell recognition)

Immune function (antibody production)

Defense function (virus, bacteria)

Signal transduction (hormone)

• changes in the number and structure of sugar chains are closely related to the occurrence and development of various diseases

Changes in the number of sugar chains

Changes of sugar chain structure

      • the process of liver cancer

• clinical significance of G-test

Performance index (1100 multicenter clinical studies):

Sensitivity 83.61% (301 / 360)

Specificity 87.84% (650 / 740)

To distinguish liver disease and liver related diseases based on glycochain map from 'histology' to improve accuracy

Screening and detection of early stage liver cancer in high risk population of chronic hepatitis B, liver fibrosis and cirrhosis

According to a large number of clinical research data, the detection rate of AFP negative liver cancer can be increased by about 85%

G-test detection principle

The enzyme was used to separate the sugar chain and protein, and the N-sugar chain was labeled with fluorescence. The mixture of different molecular weight was separated by capillary electrophoresis to form a glycomics map. The final detection results were obtained by big data and algorithm analysis

G-test technology platform

Only 2ul serum was used to obtain the G-test map of human blood

        Collection of serum samples

        Subpackage of serum samples (≥ 20ul)

Note: serum samples (red or yellow cap blood vessels), ≥ 20 μ L; hemolytic serum cannot be used

• clinical data and Literature

Comparison of G-test and AFP (346 liver cancer samples)

G-test sensitivity is 84.10%

According to the guideline of liver cancer diagnosis AFP > 400, the sensitivity of AFP was 26.30%

Analysis of detection results of early liver cancer by G-test and AFP

The detection rate of G-test was 81.12%, while AFP was only 10.91%

• two year follow-up study of patients with liver diseases approved by the state key research project

Leading unit: Beijing Friendship Hospital

Of the 16 patients with positive G-test, 12 were positive at the beginning of 0 week follow-up. The early warning of liver cancer screening was 2 years ahead of schedule

G-test oligosaccharide chain detection kit (FCE) belongs to the third category of products with the highest risk and the most stringent supervision. The product has been reviewed by the State Drug Administration (nmpa) and is recognized as 'innovative medical device product'