GenTegra LLC — Department of Health and Human Services SBIR Phase II: NIAID

Description

Abstract The Flavivirusesespecially DengueZika and Yellow Fever have been a major public health concern for centuries in semi and tropical climatesincluding parts of the southern USPresentlythese viruses are the cause of more thanmillion infections per yearGlobal travelalteration of the underlying mosquito vector s geographical rangethe possibility of RNA genome mutation resulting from vector changes and new environmental selective pressures all appear to have influenced the spread of Flavivirus infection to new human populationsMore recentlyZikawith the proposed link to microcephaly and other neurological birth defectshas thrust into the spotlight an urgent need for an economicalinternational scale screening of susceptible populationsWe believe there is a critical need to develop new technology to collecttransport and recover blood or blood products containing this pervasive class of unstable enveloped RNA virusin the complete absence of any sort of protection via refrigerationThe goal of this new technology is the recovery of intact viral genomes to support viral load and nucleic acid testingto improve the diagnoses of Flavivirus infection andcoupled with newnowinexpensive methods of Next Gen sequencingto provide the real possibility of discovering how the viral genome may be mutating under selective pressureThe overarching requirement for such new sample collection and preservation technology is that it must be robust enough to preserve even the most unstable of the Flavivirus RNAsyet inexpensive enough to support both population scale public health screening and sophisticated molecular epidemiology to detect mutational driftvia Next Gen sequencingwhile being deployable in a way that facilitates implementation in isolatedtropicalpoorsusceptible populations in the complete absence of cryogenic preservationGenTegrain collaboration with Ahlstromthe world leader in medical grade filter paper for newborn screeninghave recently co developed a medical grade cellulose paper that supports long term stabilization of the DNA in blood at ambient temperatureIn this Phase II SBIRGenTegra will leverage that ongoing collaboration with Ahlstromcoupled with our expertise in the development and implementation of the new stabilization chemistriesto develop a completely new filter paper based product for Flavivirus RNA field collection and preservationTo achieve those highly Innovative and Significant goalswe proposeSpecific Aimsto be executed overyearsUpon successful completionthis program will yield a product prototype that will be ready for manufacturing scale up and international commercial deploymentThe Investigators and Research Environment among the collaborating institutionsGenTegraATCCand Ahlstromare of international caliber with respect to delivering thisst centuryapproach to paper based biosample collectionIt should be noted thatalthough this SBIR is purely focused on Flavivirusthe technology may be generally applicable to ambient temperature collection and transport of all RNA viruses in animals and man