AC Pharmaceuticals Core Technology in Emerging Molecular Diagnostics
Molecular Diagnostics in recent years developed DNA and RNA-based diagnostic analysis is a branch of clinical medicine. In recent years, molecular diagnostic medicine has started from the traditional molecular diagnostics, pathogen detection that began to develop new molecular diagnostic medicine. Emerging molecular diagnostic medicine mainly in the molecular (genetic) level detection in the human body Genetic Characteristics of the different, the target gene in the drug testing, prenatal and postnatal diagnosis of disease, cancer and other diseases of Ji Yin diagnosis is widely used Fangmian prospects.
Molecular diagnostic medicine as related to the development of molecular technology. The concept of molecular diagnosis of early eighties of last century has been widely known, but the real clinical widely used in the last 5 years is only just beginning. The main benefit from the implementation of the human genome project, people's understanding of various diseases, especially cancer awareness has been a revolutionary change. From the genetic level detection of diseases, development and potential treatment target sites as biomedical hot, so there is illness in the saying genotyping. For different genetic changes, are divided into different tumor subtypes, the different treatment measures taken to secure the best treatment time, protects the efficacy, which is now cancer researchers. Different genes of drugs like Gleevec, Herceptin, a variety of human monoclonal antibodies, require a genetic level of the disease clear result, to get the real effect of the clinical treatment of these drugs in clinical huge success, it also promotes related research and monitoring of development. Hematology Oncology progress and success of treatment, primarily due to chromosome analysis and FISH testing help. Today, PCR, ELISA, immunohistochemistry, gene sequencing, FISH has become an important clinical molecular diagnostics development. Many experts believe that chip technology will also be gradually simplified into clinical application.
Emerging molecular diagnostic medicine is mainly used in the molecular (genetic) level detection of different genetic characteristics, such as cancer drug target gene detection (Personalized Medicine), predict the risk of tumor recurrence, prenatal diagnosis of associated diseases, cancer and other diseases of genetic diagnosis. A wide range of emerging applications of molecular diagnostics. One important aspect of the application is to detect cancer drug target gene (Personalized Medicine).
Cancer drug target gene detection (Companion Diagnostics) is based tumor targeted drug therapy developed from, is the rapid development of molecular diagnostics, a wider field of application. Cancer chemotherapy for a long period of time, for the control and treatment of cancer contributed. However, However, due to the selective chemotherapy of small, toxic side effects, its use had been greatly hindered. Targeted therapy of tumors developed in recent years new technologies of drug treatment. The principle is based on the body's molecular mechanism of tumor development, the use of targeted small molecule drugs or protein blocked one of the one part, thereby to control and cured. Typical targeted drugs include Roche / Genentech's Avastin and Herceptin; Eli Lilly / ImClone's Erbitux. Avastin mainly by blocking vascular endothelial growth factor (VEGF) to achieve the blocking blood supply to tumor cells, thereby limiting tumor growth and spread. Avastin is already approved for colon cancer, lung cancer, breast cancer and kidney cancer treatment. The mechanism of Herceptin by blocking the HER2 gene in tumor cells to achieve the purpose of inhibiting tumor cell growth. And Eli Lilly's Erbitux is within tumor cells by blocking epidermal growth factor (EGF) to achieve the purpose of inhibiting tumor cell growth.
Detection of cancer drug target gene is mainly detected through analysis of individual patient that a specific gene in vivo, in order to provide the basis for targeted drug applications. A good example is Novartis for chronic myeloid leukemia therapy GLEEVEC. Gleevec has only to patients for BCR / ABL gene rearrangement in chronic myeloid leukemia is better. Adult chronic myelogenous leukemia most of the changes in the genes (BCR / ABL), but not all. Only a minority of children with leukemia have this genetic shift, could use the drug. Gastrointestinal cancer (a small 5-10%) can also be use of this drug. There are above Herceptin, only HER2 gene overexpression in vivo of patients effectively. KRAS gene in vivo positive Erbitux patients better. This type of genetic testing is mainly the body by detecting a particular gene, so as to achieve the individual drugs (Personalized Medicine).
Targeted drug alone or in combination with chemotherapy drugs is the future direction of development of cancer drugs.From the development perspective, similar drugs will be targeted more and more. The selection of these drugs, efficacy monitoring shall be appropriate testing to help, so for the molecular detection of target genes will have a big development. Relative to the treatment drugs, the development of diagnostic reagents with low cost, short cycle characteristics. The two have similar profit margins. Valuation in the market, the franchise valuations molecular diagnostics company and the exclusive treatment of drugs in the valuation of biotechnology companies as good as or even higher. The diagnostic reagent companies that invest in low cost and fast convergence.
Other important emerging applications of molecular diagnostics, including cancer gene diagnosis and prognosis, recurrence risk prediction, in vitro fertilization and prenatal diagnosis of associated diseases and so on.
In situ hybridization (FISH) technology, is a change in the molecular genetics test cell technology. The fluorescent pigment labeled probe technology, and patient samples were hybridized chromosomes, and then observed under a fluorescence microscope changes. FISH technology itself is relatively simple, reproducible, stable, and has high sensitivity and specificity. Compared with traditional methods, FISH technology is the genetic testing, compared with the morphological detection of abnormal cells can be found earlier, a significant reduction in the rate of misdiagnosis; but the technology is a fast non-invasive detection techniques. In PCR, ELISA technique, compared, FISH technology is difficult, demanding machine, on reading the technical requirements of film and technical personnel is much higher. In particular, chromosome analysis and solid tumor biopsy reading, technical requirements are very high. Overseas, the rapid development of reproductive medicine, but also contributed greatly to the development and application of FISH. Advanced maternal age (35 years), doctors have recommended amniotic fluid karyotype analysis and FISH testing, all in vitro fertilization IVF, uterus implantation prior to FISH testing to prevent the existence of a genetic anomaly. The development of domestic manufacturers in this regard very few hospitals can carry out FISH are rarely detected. Development of larger space.
Although China's diagnostic reagent market on a large number of competitors, But in terms of FISH technology-based emerging field of molecular diagnostics, only the United States, Abbott Lab, and domestic Chinese medical technology company has its own product. This is for our good opportunities for development. Clinical diagnostics market in China is the size of about 30 billion to 4 billion yuan, with an average annual growth rate of about 20%. The market is big. China's current molecular diagnostic medicine mainly concentrated in traditional areas of molecular diagnostics, namely, infectious disease pathogens. China's emerging molecular diagnostic medicine is still in the infancy stage, has broad prospects for development.
AC medicine to master the emerging molecular diagnostic medicine, FISH and other core technologies. We expect these technologies in China's pharmaceutical industry, is committed to developing a new type of independent property rights in China diagnostic reagents and products for the Chinese people's health and contribute to the modernization of Chinese medicine.
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