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Northbrook, IL, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 291.29K | Year: 2007

DESCRIPTION (provided by applicant): The aim of this research SBIR application is to develop a paradigm shift in diagnostic testing for a globally important, yet poorly diagnosed, healthcare-associated infectious disease, namely Clostridium difficile-associated diarrhea, or CDAD. Current laboratory testing for CDAD is limited to detection of the organism and/or its toxin product(s) and does not differentiate infected from simply colonized patients, thus leading to inaccurate diagnosis as well as antibiotic miss/overuse. To overcome these limitations, an ultra-sensitive assay that detects both microbial and host response targets for CDAD will be developed using Nanosphere's bio-barcode assay technology. In phase I, protein and DNA-based Bio-barcode assays that target toxin B (microbial target) and tropomyosin (host-response) will be developed along with protocols for stool specimen preparation. The feasibility of this new approach will be established by testing for CDAD in stool samples. In phase II, the assays will be further optimized to maximize sensitivity and specificity, and instrumentation and software will be optimized to provide a stand-alone 'kit' format that is rapid (complete testing from specimen receipt to a final result in well under 4 hours), reliable (with sensitivity and specificity greater than 95%), easy to use (so that accredited laboratories can perform the assay), and cost efficient. Clostridium difficile-associated diarrhea, or CDAD, is a globally important, yet poorly diagnosed, healthcare-associated infectious disease. Importantly, the causative agent of this disease has become a crucial emerging pathogen with new virulent strains seen in the hospital, apparent emergence of community acquired disease and recognition of CDAD as a key pathogen for HIV-infected persons. A more specific and sensitive diagnostic platform will improve patient care by enabling specific, correct treatment at a very early time point, thus lowering the potential risk of severe disease and death as well as lower the overuse of antimicrobial agents.


An apparatus and method for imaging metallic nanoparticles is provided. Preferably, the invention provides for an apparatus and method for detection of gold colloid particles and for accurate reporting to the operator. The apparatus includes a substrate holder for holding the substrate, a processor and memory device, an imaging module, an illumination module, a power module, an input module, and an output module. The apparatus may have a stationary substrate holder and imaging module which are proximate to one another. The apparatus provided for a compact sized system without the need for complex motorized devices to move the camera across the substrate. Further, the apparatus and method provide for automatic detection of the spots/wells on the substrate, automatic quantification of the spots on the substrate, and automatic interpretation of the spots based on decision statistics.


Trademark
Nanosphere | Date: 2015-04-24

Computer software for enabling users to electronically view test results of a user-selected subset of targets on a microarray; computer software for storing in memory the user-selected subset of targets on a microarray for which a user can pay, and be charged for, only that user-selected subset of targets, all for research or diagnostic testing in clinical and medical laboratories.


Patent
Nanosphere | Date: 2012-12-18

The invention relates to methods for detecting complexes of Tau, Tau variants, including phosphorylated variants, and amyloid containing molecules, as well as autoantibodies to those complexes or components of those complexes, in physiological fluid samples.


A method includes applying ultrasound to a container having a plurality of magnetic particles contacted with a fluid sample having a biological material capable of binding to the magnetic particles, in an amount effective to suspend the magnetic particles in the fluid.

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