Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.49M | Year: 2015
DESCRIPTION provided by applicant The global HIV AIDS epidemic continues to be fueled by the large number of individuals who do not know that they are infected The CDC is supporting programs to decrease this number by encouraging more frequent testing of all age groups as well as increasing the venues for testing including the recent FDA approval of an oral HIV Screening test for anti HIV antibodies That said a reactive i e positive test still requies a confirmatory test that often requires a second visit to a health professional Additionally ther is a andquot seroconversionandquot window of many weeks from the time of infection until antibodies to the virus can be detected In this interval HIV viral loads are at their highest levels increasing the chance for transmission to other individuals Over the past several years Rheonix Inc and NYU have been collaborating on a novel point of care device to simultaneously detect both anti HIV antibodies and viral nucleic acid in less than hour Starting with a drop of blood or a saliva sample we have been able to combine a screening test antibody using lateral flow with a confirmatory molecular test for viral RNA utilizing isothermal amplification LAMP Employing Rheonixandapos s patented technology the device being developed utilizes a microfluidic based disposable CARDandquot that can be simply operated with the push of a button to provide a yes no result for both antibody and nucleic acid in less than minutes on a device that is portable and practical for both small clinics or field use The results from the present fast track SBIR proposa will complete the development of this dual pathway device in years utilizing our preliminary data on all aspects of this innovative approach The impact of the dual pathway point of care approach will permit a andquot test and treatandquot program to rapidly identify infected individuals and accelerate their treatment ultimately decreasing the viral burden in a community PUBLIC HEALTH RELEVANCE The ability to rapidly and accurately determine if an individual is infected with HIV especially in low resource settings is critical to reducing the number of worldwide infections By developing a fully automated unattended system that will detect both antibodies to HIV and HIV viral RNA individuals of moderate skill level will be able to perform very sophisticated immunoassays and molecular confirmatory assays in a single device by merely introducing the sample and allowing the system to automatically perform all preparative analytical and readout steps Moreover since viral RNA is detectable sooner than antibodies directed against HIV early infections that might have otherwise gone undetected using standard immunologic techniques can be detected and permit immediate access to therapy A device that can accept either blood or saliva will likely have greater acceptability and provide a marketing advantage PHS Rev Page Continuation Format Page
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 189.65K | Year: 2014
DESCRIPTION (provided by applicant): The global HIV/AIDS epidemic continues to be fueled by the large number of individuals who do not know that they are infected. The CDC is supporting programs to decrease this number by encouraging more frequent testingof all age groups as well as increasing the venues for testing including the recent FDA approval of an oral HIV Screening test for anti-HIV antibodies. That said, a reactive (i.e., positive) test still requies a confirmatory test that often requires a second visit to a health professional. Additionally, ther is a seroconversion window of many weeks from the time of infection until antibodies to the virus can be detected. In this interval HIV viral loads are at their highest levels, increasing the chancefor transmission to other individuals. Over the past several years, Rheonix Inc. and NYU have been collaborating on a novel point-of-care device to simultaneously detect both anti-HIV antibodies and viral nucleic acid in less than 1 hour. Starting with a d
Rheonix Inc. | Date: 2015-01-30
A self-contained, fully automated, biological assay-performing apparatus includes a housing; a dispensing platform including a controllably-movable reagent dispensing system, disposed in the housing; a reagent supply component disposed in the housing; a pneumatic manifold removably disposed in the housing in a space shared by the dispensing platform, removably coupled to a fluidic transport layer and a plurality of reservoirs, wherein the fluidic transport layer, the reservoirs, and a test sample to be introduced therein are disposed in the housing in the space separate from the dispensing platform; a pneumatic supply system removably coupled to the pneumatic manifold in the housing in a space separate from the dispensing platform; and a control system coupled to at least one of the dispensing platform and the pneumatic supply system, disposed in the housing.
Rheonix Inc. | Date: 2014-05-02
A method for making a polymeric microfluidic structure in which two or more components (layers) of the microfluidic structure are fixedly bonded or laminated with a weak solvent bonding agent, particularly acetonitrile or a mixture of acetonitrile and alcohol. In an aspect, acetonitrile can be used as a weak solvent bonding agent to enclose a microstructure fabricated in or on a non-elastomeric polymer such as polystyrene, polycarbonate, acrylic or other linear polymer to form a three-dimensional microfluidic network. The method involves the steps of wetting at least one of the opposing surfaces of the polymeric substrate components with the weak solvent bonding agent in a given, lower temperature range, adjacently contacting the opposing surfaces, and thermally activating the bonding agent at a higher temperature than the lower temperature range for a given period of time. The contacted polymeric substrates may also be aligned prior to thermal activation and compressed during thermal activation. A laminated, polymeric microfluidic structure is also disclosed.
Rheonix Inc. | Date: 2014-09-05
A microfluidic apparatus, method, and associated applications utilize and apply to a formalin-fixed paraffin-embedded (FFPE) tissue sample and performing a liquid-liquid extraction to remove the paraffin from the tissue sample prior to a nucleic acid purification step. A microfluidic device includes a dedicated liquid-liquid extraction process vessel, a nucleic acid purification process component, and a nucleic acid amplification reactor. A liquid-liquid extraction and nucleic acid purification kit includes a microfluidic device capable of performing both a liquid-liquid extraction process and a nucleic acid purification process, including a dedicated liquid-liquid extraction process vessel, an immiscible liquid or a precursor phase thereof disposed in the vessel, a nucleic acid purification process component, a nucleic acid amplification reactor fluidically, and a supply of reagents suitable to enable the liquid-liquid extraction process and the nucleic acid purification process.