Portable, Hand-Held, High Speed, PCR Thermal Cycler with Real-Time Optical Detection

Cepheid proposes to develop a hand-held, battery-operated, high-speed DNA diagnostic instrument with true real-time, multi-wavelength optical detection and integrated sample purification modules. This instrument will allow practitioners to perform PCR reactions 5-10 times faster than almost all commercial instruments (i.e., 30 PCR cycles in as little as 15 minutes). It will also perform real-time fluorescence detection of up to four separate DNA targets, avoiding post-amplification verification of products (such as electrophoresis) , further decreasing the time of analysis. Phase I will provide the requisite analysis and engineering design for the extension of a previously proven portable prototype thermal cycling instrument into a commercial product. Due to existing interest by third party investors, including diagnostic and life science research product companies, and financial institutions; Cepheid anticipates being able to participate in a Fast Track program. During Phase II, Cepheid will integrate the separate computer controller with the analytical thermal cycling instrument into a single hand-held package, suitable for high volume production. The Phase II product represents a significant step toward Cepheid's vision of a powerful, portable DNA diagnostic instrument capable of receiving raw samples, such as whole blood, extracting and purifying target nucleic acids (DNA and/or RNA), performing amplification, and identifying and quantifying target organisms or sequences. BENEFITS: Instruments based on this approach could be used in biowarfare and medical defense applications, and for rapidly diagnosing diseases (and disease vectors) in the field. Commercial versions will have diverse applications such as identifying infected or contaminated livestock, food, water supplies, and infectious disease diagnostics in the doctor's office or the emergency room. It will lower the cost of such instruments while increasing the speed of analysis.