Engineering Research Centre of Molecular Diagnostics, Ministry of Education (ERCMD) founded in 2009 is committed to translating the flourishing research achievements in this school into advanced clinical applications. Such a role makes ERCMD hold a unique position as a research and development unit. Instead of exploring basic mechanisms, our center focuses on developing applicable techniques and visible products, which will have to integrate multiple disciplines like biology, chemistry, physics, medicine, engineering and informatics and soon. In this context, we are especially interested in establishing collaboration with scientists from different areas, doctors from various departments, and industry or investors that have potential interests in MDx.
ERCMD is now composed of the following four units:
1)Biomarker and Targets Development for MDx
To develop and validate novel markers that can be used to diagnose diseases, to predict prognosis and to monitor therapeutic outcome. For instance, we have validated 21 genes for breast cancer prognosis, 5 methylated genes for diagnosis of colon cancer. Now work is going on the validation of a number of SNPs in their use for determination of drug response or dosage. Future work is oriented for biomarker development using those high throughput screening tools like next generation sequencing.
2)Research reagent and diagnostic kits development for MDx
This unit is good at kit development after a new method has been established for certain diseases. We have developed many novel and user friendly methods for clinical diagnosis of infectious diseases, inherited diseases, and several types of cancers. Many of these methods have been formulated into clinical diagnostic kit. This process is challenging when considering the quality control, industrialization technology and regulation barrier. However, ERCMD has a lot of experience in accomplishing such a goal. More than 10 kits are in the different stage of SFDA approval and more are being spin out to become approved kits for future clinical use.
3) Material and device development for MDx
Many basic materials such as DNA polymerases, labeled probes, positive controls, etc., are needed in MDx. Despite their commercial availability, the quality is far from satisfaction according to the MDx level. Moreover, some special techniques, often the late ones, require special feature that cannot be found in the existing materials. The same situation is encountered in some devices for MDx. Therefore, we are working hard to improve existing materials and even design new devices for different applications. So far, we have successfully synthesized special primers for allele-specific amplification, new hot-start Taq DNA polymerase, and thermostable MMLV, etc. New devices such as the integrated MDx system are now under development.
4) Clinical service laboratory for MDx.
In order to directly apply our expertise in MDx to people, a clinical service laboratory is under construction in collaboration with doctors in local area. Such a laboratory will offer molecular diagnostics service using our own approved kits as well as well-recognized techniques developed elsewhere.