Fully-Integrated, Non-Instrumented Device for Molecular Diagnostics

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DESCRIPTION (provided by applicant): The training and research experience provided by this Mentored Career Development Award (K25) will enable me to successfully transition from a background in chemistry (B.S. and M.S.), electronic engineering (Ph.D.) and mechanical engineering (Postdoc) to become an independent biomedical researcher. To achieve this, I will work closely with my mentors, Dr. Haim H. Bau (an expert in microfluidics and nanofluidics), Dr. Robert Gross (an international authority in infectious disease, with a focus on HIV), Dr. Frederic Bushman (a Molecular Virologist) and Dr. Paul H. Edelstein (a Clinical Microbiology expert). The training includes 1) coursework in genetics, epidemiology, biostatistics, molecular biology and nanomedicine, 2) experimental-skill training in infectious disease assays, molecular biology, and clinical treatment 3) professional development activities through workshops and networking opportunities. The goal of this training is to allow me to gain the knowledge and skills necessary to apply for independent NIH funding (e.g., R01 awards). To complement the training, I propose a research plan aimed at researching and developing a fully-integrated, low-cost, non-instrumented, POC device for HIV viral load measurement using blood samples. This device will be nearly as simple as a 'dipstick' immunoassay with performance that is comparable to that of benchtop PCR. HIV is a significant global health problem. Recent estimates suggest ~33 million people are living with HIV, with 96% residing in the developing world. While antiretroviral therapy is effective and increasingly available, quantitative monitoring of patients is necessary t individualize drug treatment, and to control the emergence and spread of drug-resistant strains of HIV. The level of circulating virus in the blood plasma, or "viral load," is a critical measure used to monitor disease progression and make treatment decisions. Typically, quantitative PCR-based assays, which require expensive equipment, skilled technicians, and laboratory facilities and that are not widely available for point-of-care testing in resource-limited settings are needed to assess viral load. The innovative POC test devices proposed in this K25 will address this need. My career goal is to become an independent, multidisciplinary and well established biomedical researcher with expertise in developing low-cost diagnostic technology for global health care and for individualized medicine. PUBLIC HEALTH RELEVANCE: The proposed K25 effort will lead to a new generation of point-of-care (POC) diagnostic devices that will enable widespread screening and diagnosis for infectious diseases such as HIV, malaria, and HCV. A low-cost, non-instrumented, simple-to-operate microfluidic device will process blood samples and detect pathogen-associated nucleic acids with high sensitivity and specificity, fostering improved healthcare for both the USA and resource-poor settings, and better informing epidemic eradication and 'test and treat' programs to stem pandemics such as HIV. The work will focus on a POC device for assaying viral load in HIV- infected patients in order to monitor disease progress and optimize individualized anti-viral drug therapy.