RESEARCH PROGRAM V – Diagnostics: Development, Support and Discovery

Program Shepherds: Richard Rothman (Johns Hopkins University School of Medicine, [JHU]) and Chris Geddes (University of Maryland Biotechnology Institute, [UMBI])

Research Program V will incorporate state of-the-art technologies and translational research capacity and will promote relationships with biotechnology companies that may lead to product development, with a particular emphasis on broad-based platforms. The Program will be comprised of two ‘hubs’ that will house proven technologies well along the pathway toward commercialization and licensure.

The Universal Nucleic Acid Amplification Technology (NAAT) hub will house platforms that exploit broad-based PCR methods which, when combined with innovative, simple and rapid post-amplification detection techniques, will allow specific target detection. Two complementary platforms which will be further developed and refined include the 16S rRNA technology and the IBIS T-5000 system for rapid detection of a wide variety of pathogens through the use of both animal and human samples. The second Hub will leverage the microwave-accelerated, metal-enhanced fluorescence (MAMEF) platform by developing a multiplexed capacity for several agents in a high throughput screening (HTS) format. The technology has the potential to detect a wide range of agents and viruses simultaneously in mixed complex media such as whole blood, with little to no pre-processing time. To further support the central theme of Program V, which is to discover, develop, and support broad-based diagnostic methodologies with capacity for select target identification, a series of ‘spoke’ projects (centered on new, higher risk, innovative approaches or technologies complementary to those represented in the Hubs) will be selected for Developmental Awards in Year 1.

Universal Nucleic Acid Amplification Tests (NAAT) - Diagnostics Hub 1

Universal Nucleic Acid Amplification Test (NAAT) platforms rely on the discovery that conserved and variable sequences contained in all human pathogens can be exploited for development of robust rapid diagnostic methods. We will grow two already advanced broad based diagnostic platforms which will both support Program Projects in the Center, and establish utility for dual use, i.e. biodefense/emerging infections and commonly encountered clinical infections, increasing likelihood of commercialization.

Multiplexed Ultra Fast and Sensitive Bioagent Assays - Diagnostics Hub 2

Fast, sensitive and agent specific tests are the fundamental underlying technologies behind the development of Bioagent diagnostic devices. Technologies which are widely used today such as RT-PCR, are either agent specific but not fast enough, or require sample collection in the field for analytical evaluation by a suite of approaches in a laboratory both some time and distance away. Even when in the laboratory, the collected samples can still take many hrs to analyze individually.

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