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Kits for high-multiplexed detection of RNA viruses in complex biological samples

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43GM114967-01
Agency Tracking Number: R43GM114967
Amount: $149,693.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA14-071
Solicitation Year: 2015
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-09-25
Award End Date (Contract End Date): 2016-03-24
Small Business Information
13709 Progress Boulevard, Box 17
Alachua, FL 32615-9544
United States
DUNS: 192849011
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (386) 418-8085
Business Contact
Phone: (386) 418-0347
Research Institution

DESCRIPTION provided by applicant The public health challenges from RNA viruses are at a tipping point with dengue moving up Florida human transmission of chickungunya now established in Florida and transmitted by different mechanism Ebola While these have long been a challenge their incidence has been predominantly overseas In addition the health hazards of other RNA viruses better known in the United States remains unabated Eastern equine encephalitis is again emerging in New England with its mortality rate West Nile virus continues as an important health hazard Further given the speed of international travel and the ease with which the sequences of RNA viruses mutate a public health official can easily have a mosquito that carries an RNA virus from one of these classes that is nevertheless not detected by PCR with standard primers This creates a need for exactly the product that Firebirdandapos s technologies enable These technologies are Self avoiding molecular recognition systems SAMRS SAMRS primers do not interact with each other This allows unlimited multiplexing of PCR Further SAMRS allows additional targets to be added to an assay without the multiplex collapsing SAMRS also suppresses primer dimers in isothermal amplification e g RPA HDA making possible in Phase point of sampling kits SAMRS therefore supports a highly adaptable molecular diagnostics able to detect dozens of RNA species for essentially the cost of detecting one Artificially expanded genetic information systems AEGIS AEGIS adds nucleotides to the four in standard DNA and RNA collectively xNA Thus AEGIS generates primers that cannot complement any natural DNA no matter how complex the sample supporting assays with very low noise and very few false positives Universal base technology Biversals RNA viruses easily mutate exemplifying the consequences to public health recent surveillance of HIV infected patients with the goal of measuring incidence found that the viruses in of the isolates were not PCR amplified by standard primers Firebirdandapos s evolutionary analyses show that mutations often occur in silent sites in coding regions Thus Firebird scientist invented andquot biversalandquot nucleobases that prime on either A or G the Y biversal or
on either T or C the R biversal Phase will generate a kit to detect common mosquito borne RNA viruses allowing public health staff to screen on a Luminex platform for all of these for less than $ less than the cost of detecting any two RNA viruses separately In Phase these will be moved to simpler platforms Firebirdandapos s pipeline investments allow us to prepare AEGIS and SAMRS building blocks in multi gram amounts and AEGIS and SAMRS oligonucleotides on demand Because surveillance assays are not heavily regulated and since its customers for those kits public health staff are well trained this product fits well within Firebirdandapos s current product line However strong performance of a low cost highly multiplexed easily adaptable and low false positive surveillance product will undoubtedly help Firebird raise capital for patient targeted applications of these technologies

PUBLIC HEALTH RELEVANCE The public health challenges presented by RNA viruses are this year reaching a tipping point with dengue moving its way up the Florida peninsula human to human transmission of chickungunya now established in the United States which until this year was always imported from an exotic tropical locale Eastern equine encephalitis now being detected in New England with a mortality rate and of course operating by an entirely different mechanism of transmission Ebola which is uncontrolled at this moment in Western Africa This creates a need for exactly the product that Firebirdandapos s technologies enable a highly adaptable molecular diagnostics assay that is able to detect dozens of RNA species for essentially the same cost as detecting a single RNA virus design to manage the rapid divergence of these species and capable of extraordinarily few false positives This project will develop kits that allow a single public health official in a single step to test real biological samples for example mosquitoes caught in a single trap for all RNA viruses at the same time and with the same total cost as a test for any one of them separately Since such surveillance kits have few regulatory barriers Firebird will be able to bring these kits to market
on its own before the end of the Phase project period

* Information listed above is at the time of submission. *

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