Sample Preparation and Real-Time PCR System for Non-Traditional Settings

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DESCRIPTION (provided by applicant): Real-time PCR and real-time reverse transcriptase PCR assays are highly specific for determining the presence of pathogens. However these assays are traditionally confined to the laboratory as result of the need for trained technicians to perform key steps in the process, particularly sample preparation, as well as cost and size of equipment to run these assays. New equipment platforms are needed to allow these sensitive and highly selective assays to be used in non-traditional settings such as a doctor's office and nursing homes. Lynntech proposes an innovative, easy-to-operate system that automates well-established sample preparation protocols for nucleic acid extraction and purification with a novel microfluidic thermocycler to perform real-time PCR on disposable analysis cartridges for determination of pathogens in biological samples. Fluid control is achieved on-cartridge through use of low cost components (<$0.60 per component). The PCR based system provides random access nucleic acid testing in one hour, from nucleic acid extraction and purification to amplification and real-time detection. The technology is anticipated to be able to detect a broad range of pathogens at a level between 102 to 103 units per milliliter. The system's random-access nucleic acid analysis capability allows for samples to be run whenever needed. The implementation of the system will significantly reduce diagnostic lead times. Also, important is the simplicity of the system which leads to low-cost systems. Lynntech's real-time PCR system is a next generation tool for molecular diagnostics that will enable non- specialized operators in non-traditional settings (e.g., nurse at doctor's office or nursing home) to perform sophisticated biological tests in any setting with greater speed at low cost. The automation provided in this system significantly simplifies and accelerates testing, thus delivering molecular diagnostics into the hands of health-care professionals (i.e., doctors and nurses). The system will be a great resource for poor communities and countries where traditional tests are not available or are cost prohibitive. PUBLIC HEALTH RELEVANCE: The technology provides needed simplification and automation to nucleic acid based diagnostic assays to bring them out of the laboratory and into non-traditional environments. The system will have great commercial potential and medical value in providing rapid, low-cost, easy-to-use in vitro diagnostics in doctors' offices, clinics, hospitals, and even in poor communities and countries.