Molecular diagnostics is the fastest-growing segment of the in-vitro diagnostics market. Nearly all molecular diagnostics assays use various amplification techniques such as polymerase chain reaction (PCR) to amplify specific sequence segments to easily detectable quantities. However, instead of being performed as a point-of-care format as originally envisioned, many of these nucleic acid technology based (NAT) tests are still performed at a centralized location. The time required for sample shipping and waiting for enough samples to start a high throughput system for cost-effective usage diminishes the power of these NAT techniques. One of the biggest problems of commercializing NAT for non-centralized laboratory is the cost of the device used to detect the target from PCR amplification. Over the past few years, many nucleic acid sensors have been invented with a variety of optical, acoustic, and electronic detection approaches. Fluorescent detection has been the dominating method, however it requires sophisticated optical detection systems, plus they have high cost/mass/power requirements. There is a genuine need to couple amplification-based methods with a simple and cost-effective method for molecular diagnostics in non-laboratory scenarios. Various approaches to exploit advances in nanotechnology for bioanalysis have also been recently reported. Several companies including Lynntech are investigating the use of noble metal nanoparticles and nanostructures as optical transducers of biomolecular binding events. Using our innovative gold nanoparticles based nucleic acid detection technology, Lynntech aims to design and develop a multiplexed, sensitive, and affordable in-vitro diagnostic system for use in non-laboratory settings with minimum labor intensity. The Phase I study successfully demonstrated the use of gold nanoparticles in a novel assay for the detection of DNA. The new method is unique in its simplicity, facilitating its use in a low-cost automated PCR-assay. The method has the potential to be low cost because it uses a simple optical detector and is significantly faster than conventional microbiology based methods. The Phase I study also included assembly and testing of initial engineering designs of the hardware to be used in conjunction with a nanoparticle DNA detection (NDD) assay. In this Phase II proposal, Lynntech will expand our understanding of complexes that form between DNA and gold nanoparticles and incorporate this knowledge to further optimize the rapid assay. Coupled with an innovative highly multiplexed PCR amplification technology from our alliance partner, Genaco Biomedical Products, Inc., the system will provide molecular differential diagnostics of infectious diseases. When successfully developed, the NDD assay will expand the range of applications for amplification based molecular assays, facilitating its use in food safety, detection of biological weapons, rapid analysis of blood products and environmental monitoring, etc. Highly infectious diseases such as SARS and bird flu are global health threats. Having a non-laboratory set up to test the patients and animals and to provide immediate results on location can help stopping the spread of the diseases a great deal. Molecular diagnostics is the fastest-growing segment of the in-vitro diagnostics market. By 2010, a U.S. market of $3.7 billion is expected, representing a significant opportunity for commercialization. ? ? ?
