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Lexington, MA, United States

Patent
Bioscale | Date: 2010-05-25

Methods and apparatus for analyzing bioprocess fluids are provided. A plurality of particles coated with a plurality of capture agents having an affinity for one or more biological markers is combined with bioprocess fluid to form a plurality of analyte-particle complexes. The system also includes a transport arrangement for transporting the sample to a sensor surface, and optionally a magnetic field inducing structure constructed and arranged to establish a magnetic field at and adjacent to the sensor surface. The resonant sensor produces a signal corresponding to an amount of analyte-particle complexes that are bound to the sensor surface.


In one non-limiting aspect, the invention provides a method for detecting the quality of a biological molecule comprising forming a first mixture of ingredients comprising: (i) a first binding agent that specifically binds to a tag, wherein the first binding agent is attached to a solid support; (ii) a decoy comprising a first portion comprising the tag attached to a second portion comprising an anchor; (iii) a sensor attached to a second binding agent that specifically binds to the anchor; and (iv) a sample suspected of containing a high quality biological molecule comprising a tag, wherein the tag of the high quality biological molecule is accessible; allowing interaction of the ingredients such that the sensor provides an output signal


Grant
Agency: Department of Defense | Branch: Office for Chemical and Biological Defense | Program: SBIR | Phase: Phase II | Award Amount: 741.36K | Year: 2005

Having achieved or exceeded all goals and objectives of the Phase I research program, BioScale has thus demonstrated feasibility of a multiplexed, immuno-electromechanical pathogen detection method. In Phase II, BioScale proposes to advance this research by assembling a complete assay system that integrates discrete, commercial off the shelf (COTS) sample preparation subcomponents with the proprietary BioScale detection platform for the purpose of validation testing. In the Baseline Proposal, BioScale will demonstrate detection of multiple pathogens using inoculated food matrices with analyses being in a non-multiplexed format. Two follow-on options are proposed: In Option A, BioScale proposes to demonstrate multiplexed detection of pathogens that were studied in the baseline effort. For Option B, BioScale proposes to conduct challenge testing (i.e., specificity and sensitivity testing) that will simulate conditions expected to be encountered in the field, especially regarding potential interfering organisms.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 265.64K | Year: 2005

DESCRIPTION (provided by applicant): The lack of affordable and practical HIV diagnostics, including assays to monitor HIV RNA levels ("viral load") and to diagnose HIV infection in infants, has been identified as a major barrier to HIV care worldwide. For resource-limited settings, a useful HIV RNA diagnostic assay would be simple, automated, and rapid and cost less than $10 per test. We propose to develop an HIV virion assay that meets these specifications using BioScale's proprietary sensor format. We hypothesize that capturing whole virions with specific physiological receptors (DC-SIGN, CD4) and/or new monoclonal antibodies against surface epitopes and integrating them into an assay on BioScale's detection platform will provide a sensitive new diagnostic that meets requirements of resource-poor setting. In the first year of the project, capture surfaces will be functionalized using recombinant soluble CD4, recombinant soluble DC-SIGN, and new anti-gp41 and anti-gp120 antibodies to create a novel system to capture and isolate HIV virions and anchor them to the sensor surface. In the second year, this new HIV virion assay will be optimized and validated for sensitivity and specificity compared to standard viral load measurements (i.e. RT-PCR) in 75 HIV-infected subjects. The successful completion of this proposal will demonstrate the feasibility of BioScale's HIV assay for resource-limited settings. The specific aims of the proposal are three-fold: A) To develop a method to capture HIV virions using magnetic beads coated with receptors and/or new monoclonal antibodies; B) To develop a bead capture surface on the BioScale biosensor and integrate it with HIV capture beads, to create an HIV virion assay; and C) To evaluate the qualitative and quantitative threshold of HIV detection in whole blood via HIV assay testing compared to RT-PCR in HIV-infected subjects. The Phase II of this proposal is anticipated to include beta-testing of the instrument, larger clinical testing, and preparation for instrument and assay kit manufacturing and deployment in resource-limited settings.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 530.00K | Year: 2007

DESCRIPTION (provided by applicant): The lack of affordable and practical HIV diagnostics, including assays to monitor HIV RNA levels ("viral load") has been identified as a major barrier to HIV care worldwide. An inexpensive, rugged and easy-to- use diagnostic able to measure viral load with rapid time-to-result would revolutionize HIV monitoring and infant diagnosis in the resource-scarce regions most impacted by HIV disease, helping to narrow the health care quality gap between the developed and developing world. In the awarded Phase I, BioScale, Inc. and Dr. William Rodriguez of Massachusetts General Hospital (MGH) teamed up to initiate development of an HIV viral load diagnostic suited for resource-limited settings, in response to SBIR-AT-NIAID, which called for the advancement of assays for infectious and immunological disease diagnosis on novel advanced technology platforms. We believe that the unique properties of BioScale's sensor system meet the rigorous needs of an HIV viral load diagnostic for point-of- care use in resource-poor settings: rapid, easy-to-use, automatable sample preparation, inexpensive, rugged with low-power consumption. We have successfully completed the specific aims in our Phase I program and plan to continue development and validation of a field-deployable HIV viral load diagnostic. The specific aims of our Phase II application are: 1. To evaluate the accuracy, threshold of detection and usability of a laboratory prototype instrument (alpha unit) and version 1.0 assay in clinical samples, in comparison to gold standard HIV viral load assays. 2. To develop a field deployable prototype instrument (beta unit), and 3. To evaluate the field deployable unit for accuracy, detection threshold and usability for infant HIV diagnosis and adult HIV viral load quantification. As with existing gold standard HIV viral detection methods, such as RT-PCR, BioScale's proposed assay has two distinct applications: quantitative measurement of HIV viral load in adults for disease monitoring; and qualitative infant diagnosis to determine the presence or absence of HIV infection in infants below 15 months of age. Both diagnostic assays are urgently needed in resource-limited settings. The lack of affordable and practical HIV diagnostics, including assays to monitor HIV RNA levels ("viral load") is a major barrier to HIV care worldwide. BioScale's proposed inexpensive, rugged and easy-to-use diagnostic for measuring viral load with rapid time- to-result would revolutionize HIV monitoring and infant diagnosis in the resource-scarce regions most impacted by HIV disease, helping to narrow the health care quality gap between the developed and developing world.

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