ZyGEM Corp. Ltd., has introduced its new microbial fingerprinting diagnostic technology that is expected to dramatically reduce the complexity and time needed to identify unknown infectious agents in mixed population samples. The approach is designed to run on the company’s new MicroLab platform and has the potential to accurately identify up to 30 types of microbes simultaneously from a single sample in less than an hour. The ZyGEM system combines ZyGEM’s proprietary DNA extraction and microbial detection technologies with PCR amplification in a single automated reaction that occurs in its integrated ZyGEM/MicroLab microfluidic device. This device miniaturizes the entire DNA testing process within a single closed system, which significantly reduces the amount of sample and reagents needed while virtually eliminating the chance for handling error or contamination. ZyGEM researchers have developed a catalog of “fingerprints,” or DNA markers, for a broad range of microorganisms. Special software developed for the system uses these fingerprints to identify and discriminate between the microorganisms in mixed microbial populations.
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA