Diagnostic Device for Norovirus Gastroenteritis

Firebird will deliver a hand-held CLIA-waivable battery-powered device that will allow point-of-need detection of norovirus RNA, with a fluorescence readout excited by a battery-powered LED. The readout can be interpreted at the point-of-need, or transmitted by cell phone to a distant site. This devise is possible only through the application of five technologies to which Firebird has exclusive access: (a) Artificially expanded genetic information systems (AEGIS), which allow low-noise amplification of DNA and RNA (collectively xNA) from a sample; (b) self-avoiding molecular recognition systems (SAMRS), which allow introduction of multiple primers and probes to give highly multiplexed and highly flexible xNA-targeted assays; (c) isothermal xNA amplification architectures using helicase-dependent amplification (HDA), which allows xNA to be targeted without the thermocycling needed for PCR (PCR will not be forward-deployed by the Army); (d) AEGIS beacons, which allow signal readout without interference from competing natural xNA, allowing ?soup-to-nuts assays? without sample maniputations any more complicated than mixing; (e) The StrainTargeter bioinformatics platform, which supports the design of xNA-targeted assays for viruses (such as the norovirus) that are rapidly adapting. In Phase 1, the reagent support will be developed, with the Option period devoted to testing on Trisol inactivated norovirus samples.