CAPTIS DIAGNOSTICS — Department of Health and Human Services SBIR Phase I: NIAID

Description

SUMMARY Acute respiratory tract infections are the leading cause of infectious related mortalitythe fifth leading cause of death overallIn particularrare unrecognized acute respiratory virusARVinfection outbreaks caused many human diseases of unknown etiologyparticularly in less developed countriesIf active ARV infection can be accurately detected and effectively vaccinated or treated with the right therapythe outbreak can be prevented or controlledHowevercurrent clinical assays are mainly based on PCR panelswhich miss rare or highly mutated emerging ARVs and can t distinguish high risk infections harboring active virions from bare viral nucleic acids from previous or latent infectionsAdditionallythere is no FDA approved comprehensive diagnostic tool compatible with rare ARV or rare ARV subtype infectionTo meet this urgent and unmet clinical challengewe hypothesize that the isolation and analysis of viable ARV virions with high purity would provide an accurateeffective and low cost solution for clinical applicationsCaptis Diagnostics has developed a new IP pending carbon nanotube size tunable enrichment microdeviceCNT STEMtechnology that performs label free virion capture from clinical and environmental samplesThe CNT STEM system can maintain virus viability infectivity and has been demonstrated to identify an emerging HNavian influenza virusAIVfrom swab samples of wild ducks and a new infectious bursa disease virusIBDVstrain from turkey eyelid tissue that was previously unidentifiable by common serological and molecular methodsFurthermoreCNT STEM captures viruses with overefficiency and boosts the detection limits virus isolation bytimesIt also increases the ratio of viral reads in next generation sequencing by more thantimesIn this proposalwe propose to further optimize our proprietary CNT STEM technology for virus isolation and coupled with high throughput sequencing to detect ARV in nasopharyngeal swab samples with high sensitivity and specificityFor AimCaptis Diagnostics will optimize and validate CNT STEM technology to develop it to a research device for ARV capture that can achieve high isolation efficiency of whole virionsAimwill develop a proof of concept clinical assay to detect whole ARV virions by coupling efficient high throughput sequencing technology with CNT STEM based viable virion isolationSuccessful completion of these Aims will yield a proprietary advanced technology that can isolate rare ARVs and position Captis Diagnostics to pursue clinical validation of the technology in patients of ARV infectionPhase II study will focus on clinical performance of ARV diagnosisin which CNT STEM based virus isolation technology will be tested with samples from ARV infection patients to validate its clinical utility with the ultimate goal of its clinical adoption and FDA clearance Narrative Acute respiratory virus infection is one of the leading causes of death worldwideespecially in less developed countriesWe hypothesize that the isolation of viable acute respiratory tract virions would provide accurate and comprehensive diagnosis and propose to further develop a nanomaterial integrated microdevice technology to achieve thisVirions will be isolated from nasopharyngeal swabs by the microdevice and identified by viral nucleic acid sequencing