Great news! Two products of KBM biology have won national class III IVD registration certificate

good news! good news! good news!

On January 8, 2020, Hangzhou KBM Life sciences Co.,Ltd was approved by the National Medical Products Administration for two registration certificates for in vitro diagnostic reagents.

1. Human ACE genotyping test kit (fluorescence-PCR method)

The human ACE genotyping test kit (fluorescence-PCR method), the registration certificate number is National Machinery Note 20203400008. This product is used to qualitatively detect human ACE (I/D 289 alu +/-) gene polymorphism in vitro from genomic DNA extracted from human peripheral blood samples.

The renin-angiotensin system plays an important role in the regulation of blood pressure, blood flow and internal environment. Among them, angiotensin II is one of the most powerful vasoconstrictors known so far, and angiotensin II is the It is derived from the decomposition of angiotensin I by ACE. Therefore, ACE is a key enzyme of the renin-angiotensin system.

The enzymatic activity of ACE is directly related to the drug effect, and its activity is directly related to the insertion and deletion of the Alu fragment on the gene. Therefore, ACE can also be divided into deletion heterozygotes (D/D), indel heterozygotes (D/I), and insertion homozygotes (I/I). Angiotensin-converting enzyme inhibitor drugs have different effects on different types of ACE mutations. In other words, the difference in the types of ACE mutations is directly related to the types of drugs used by patients. Angiotensin-converting enzyme inhibitor drugs commonly used clinically include benazepril, fosinopril, enalapril, imidapril and so on.

2. Human AGTR1 and CYP2C9*3 Genotyping Test Kit (Fluorescence-PCR Method)

Human AGTR1 and CYP2C9*3 genotyping test kit (fluorescence-PCR method), the registration certificate number is National Machinery Note 20203400010. This product is used to qualitatively detect human AGTR1 (1166 A>C) and CYP2C9*3 (1075 A>C) gene polymorphisms in genomic DNA extracted from human peripheral blood samples.

Exogenous or endogenous active substances need to bind to specific parts of the body to produce biological effects. Such biological macromolecules that can specifically recognize biologically active substances and bind to them to trigger physiological reactions or pharmacological effects are receptors. Most drugs require receptors to mediate their pharmacological effects. Angiotensin II is an important receptor, and more than 90% of its effects are mediated through angiotensin II type 1 receptor (AGTR1).

Drugs have different pharmacological effects between individuals with different genotypes of AGTR1. For hypertensive patients, A1166C and C1166C individuals are treated with angiotensin II receptor blockers, and their pharmacological effects are better than those of A1166A individuals. obvious. Angiotensin II receptor blockers used clinically include Losartan, Irbesartan, Telmisartan, etc.

Cytochrome P450 (CYP450) is a large family composed of a variety of enzymes. It is mainly distributed in the liver. It participates in the biological transformation of many endogenous and exogenous substances in the organism. It regulates the interaction between the body and the external environment and maintains the body. Play an important role in internal environment stability. In the CYP450 family, CYP2C9 is an important member and an important enzyme involved in drug metabolism. About 12% of clinical drugs are metabolized by CYP2C9.

CYP2C9 is the metabolic enzyme gene of angiotensin II receptor blockers. Mutations in this gene will cause the substrate activity of this metabolic enzyme to change. Angiotensin II receptor blocking drugs, such as Losartan, are commonly used antihypertensive drugs in clinical practice. These drugs undergo oxidative metabolism of CYP2C9 in the liver to convert to EXP3174 with antihypertensive pharmacological activity. In individuals with CYP2C9 A1075C, the conversion rate of losartan to EXP3174 with pharmacological activity is only 1/3 of that of individuals with CYP2C9 A1075A. However, the conversion rate of CYP2C9 C1075C individuals metabolizing losartan to EXP3174 with pharmacological activity is only 1/10 of that of CYP2C9 A1075A individuals. In other words, CYP2C9 A1075C and CYP2C9 C1075C individuals have a weaker clearance of angiotensin II receptor blockers than CYP2C9 A1075A, and the side effects of the drugs are increased. Therefore, the dose should be appropriately reduced when patients use the drugs. Angiotensin II receptor blockers commonly used clinically include Losartan, Irbesartan, Telmisartan, etc.

（ACE Genotyping Test Kit Registration Certificate）

（AGTR1 and CYP2C9*3 Genotyping Test Kit Registration Certificate）

Hangzhou KBM Life sciences Co.,Ltd was established in September 2012. With precision drug genetic testing as its strategic direction, it is a high-end biomedical product manufacturer dedicated to precision medicine, genetic testing, and biological scientific research services. As a national high-tech enterprise, the company has established a series of genetic testing methods, has independent intellectual property rights, and has researched and developed a full range of molecular diagnostic products for individualized drugs for cardiovascular and cerebrovascular diseases. At the same time, the company has built a first-class R&D center and GMP standard industrialization workshop, passed the ISO13485:2016 international standard quality system certification, and 7 products including the human ACE genotyping test kit have passed the European Union (CE) certification.

Hangzhou KBM Life sciences Co.,Ltd Biology takes innovation and R&D as its mission. It has applied for more than 30 patents and obtained 17 patent authorizations. There are more than 50 R&D, quality, registration and other teams, many of whom have work experience in well-known companies in the industry. The company's products will gradually enter various large and medium-sized hospitals and third-party laboratories across the country. It is planned to establish a position in the industry and strive to develop into a leader in the field of precision medicine in the field of cardiovascular and cerebrovascular!