Multiplexed Clinical Analysis
Many microfluidic technologies are designed with the idea of one device for one application. This can be a problem, according to Vincent Gau, Ph.D., president of Genefluidics. “To assay something else, you would need another type of system. Our approach is different. We developed a universal microfluidic cartridge that can measure DNAs, RNAs, proteins, and small molecules.”
The key to the device is a two-component cartridge system in which the top portion stores reagents, waste, and sample, while the bottom portion houses microfluidic channels, valves, and vents as well as the integrated sensor array. The raw sample is loaded into the top portion and the assembled cartridge is inserted into the instrument that processes and analyzes the sample. Electrochemical detection methods allow ultra-high nontarget amplified sensitivity.
Dr. Gau notes that the gold standard for most types of DNA/RNA analyses is PCR amplification of a sample whose nucleic acid was first extracted and purified. “Our devices differ because we directly take a specimen such as blood and saliva and process that to completion within 10–20 minutes. The read-out has exceeding high sensitivity because we developed our own sensors that detect proportionally to the number of target molecules.”
Another important feature of this new approach is the ability to multiplex. “We are working with VA hospitals in Los Angeles and Palo Alto on urinary tract infection screening and the UCLA hospital on salivary diagnostics for oral cancers, comments Dr. Gau. “There are many cancer and disease biomarkers relating to RNA, DNA mutations, and proteins. Often, these are evaluated singly via PCR or an ELISA if it is a protein biomarker. However, with the universal cartridge system you can characterize any combination of desired markers, not just one biomarker. We anticipate making a custom blend and a universal panel that would be informative to the physician.”
The company will launch its devices in early 2009 for academic researchers and expects to work with strategic partners to develop other specific applications especially for multiplexing.