BOULDER, CO, United States
BOULDER, CO, United States

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Patent
Mbio Diagnostics, Inc. | Date: 2014-03-13

A method for determining fluorescently labeled particles within a sample in presence of sample movement includes determining spatial shift between sequentially captured first and second images of the sample by using a third image of the sample, wherein the spatial shift is at least partially induced by the sample movement; and spatially correlating events between the first and second images, while accounting for the spatial shift. A method for providing a fluidic assay cartridge with dried reagents includes depositing a plurality of mutually incompatible liquid reagents in a respective plurality of mutually separated areas of the fluidic assay cartridge, and drying the plurality of mutually incompatible liquid reagents to form the dried reagents. A fluidic assay cartridge with dried reagents includes a plurality of mutually separated dried reagents, located within the fluidic assay cartridge, wherein the plurality of mutually separated dried reagents have a respective plurality of mutually different compositions.


Patent
Mbio Diagnostics, Inc. | Date: 2013-03-15

A rapid diagnostic system that delivers a panel of serologic assay results using a small amount of blood, serum, or plasma is described. The system includes a disposable cartridge, including an integral lens portion coupled to a planar waveguide, and a reader instrument, based on planar waveguide imaging technology. The cartridge incorporates a microarray of recombinant antigens and antibody controls in a fluidic channel, providing multiple parallel fluorescence assay results for a single sample.


Patent
Mbio Diagnostics, Inc. | Date: 2013-09-04

The present disclosure pertains to detection of biomarkers in a sample. More particularly, the disclosure relates to methods for treating the sample to liberate certain analytes prior to the assay. Composition for disrupting the HIV virus and antibody-antigen complex to release p24 antigen is also disclosed. The disclosed methods and compositions are compatible with existing HIV antigen/antibody combination assays and improve the sensitivity of such assays.


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: SMALL BUSINESS PHASE I | Award Amount: 217.70K | Year: 2016

The broader impact/commercial potential of this Small Business Innovation Research Phase I project will be to initiate development of an effective technology that will enable users in the field to perform laboratory-quality cyanotoxin testing to help protect drinking water, monitor commercial food resources, and provide critical data for ecosystems management. Harmful algal blooms (HABs) in United States and global freshwater and marine environments are increasing in frequency and duration and constitute a growing public health threat while also carrying substantial economic, ecologic, and food supply implications. The goal is to initially launch a system that delivers a panel of water toxin results in less than 15 minutes. Validation will be with customers in public health and regulatory agencies followed by placements with water resource managers of commercial drinking water systems.

The technical objectives in this Phase I research project are designed to provide a user-friendly platform with a unique combination of attributes. A cost competitive system that delivers multiple immunoassay results from a single sample using a single, simple protocol, provides lab quality accuracy and reliability, and connected data management incorporating smart phone infrastructure and cloud-based systems. This Phase I project is designed to deliver three key technical objectives. (1) One-Step Assay - deliver a single-step, < 15-minute duplex microcystin / cylindrospermopsin assay tuned to drinking water recommendations. (2) Sample Prep - establish preliminary component designs for the water sample-to-cartridge interface, including designs that enable intra-cellular and dissolved toxin methods. (3) Connectivity - develop the electronics and software infrastructure plan for distributed systems networking.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 217.70K | Year: 2016

The broader impact/commercial potential of this Small Business Innovation Research Phase I project will be to initiate development of an effective technology that will enable users in the field to perform laboratory-quality cyanotoxin testing to help protect drinking water, monitor commercial food resources, and provide critical data for ecosystems management. Harmful algal blooms (HABs) in United States and global freshwater and marine environments are increasing in frequency and duration and constitute a growing public health threat while also carrying substantial economic, ecologic, and food supply implications. The goal is to initially launch a system that delivers a panel of water toxin results in less than 15 minutes. Validation will be with customers in public health and regulatory agencies followed by placements with water resource managers of commercial drinking water systems. The technical objectives in this Phase I research project are designed to provide a user-friendly platform with a unique combination of attributes. A cost competitive system that delivers multiple immunoassay results from a single sample using a single, simple protocol, provides lab quality accuracy and reliability, and connected data management incorporating smart phone infrastructure and cloud-based systems. This Phase I project is designed to deliver three key technical objectives. (1) One-Step Assay - deliver a single-step, < 15-minute duplex microcystin / cylindrospermopsin assay tuned to drinking water recommendations. (2) Sample Prep - establish preliminary component designs for the water sample-to-cartridge interface, including designs that enable intra-cellular and dissolved toxin methods. (3) Connectivity - develop the electronics and software infrastructure plan for distributed systems networking.


Patent
Mbio Diagnostics, Inc. | Date: 2013-03-15

A particle identification system includes: a cartridge for containing a sample with fluorescently labeled particles; illumination for illuminating a region within the cartridge to stimulate emission from particles; imager for generating wavelength-filtered electronic images of the emission within at least one measurement field of the region; and particle identifier for processing the electronic images to determine a superset of particles of interest, and fluorescently labeled particles within the superset based on properties of the particles in the at least one measurement field. A method determines fluorescently labeled particles within a sample, by: processing at least one electronic image from at least one focal position within the sample; determining dimmest separation lines between brighter areas in the electronic image; and, for each of the brighter areas, determining local background level based on pixel values of the separation lines forming a perimeter therearound, to determine each of the fluorescently labeled particles.


Patent
Mbio Diagnostics, Inc. | Date: 2013-03-15

A device for analyzing an analyte in a sample includes a first substrate, a second substrate, a fluidic channel, an inlet port and an outlet port. Each of the first substrate and the second substrate has an inner surface and an outer surface, the inner surface of the first substrate forming, at least in part, the lower wall of the fluidic channel, and the inner surface of the second substrate forming, at least in part, the upper wall of the fluidic channel. The fluidic channel is connected to the inlet port and the outlet port. The fluidic channel includes a reagent region and a detection region, at least a portion of the reagent region being coated with one or more dried reagents. The device further includes a wicking pad located on the outer surface of the second substrate, the wicking pad being positioned at a pre-determined distance from the outlet port.


An assay cartridge processing system includes an agitation source for agitating assay components within an assay cartridge, and a timing module for controlling timing of agitation. An assay cartridge processing method includes applying agitation to an assay cartridge to mix assay components, and electronically controlling timing of agitation. An assay cartridge processing system includes a puncture device for puncturing an assay cartridge to allow fluid flow, and a timing module for controlling timing of puncturing. An assay cartridge processing method includes puncturing a vent of a capillary channel of an assay cartridge to allow fluid flow from an inlet port of the assay cartridge into the capillary channel, and electronically controlling timing of the step of puncturing. An assay cartridge includes a capillary channel, an inlet port, and a vent including a frangible seal for preventing fluid flow from into the capillary channel when the frangible seal is intact.


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 75.55K | Year: 2014

The PIs propose to address the difficulty of developing a small, low power, highly sensitive molecular biology tool for oceanographic work with the novel implementation of a sensor technology known as Total Internal Reflection Fluorescence (TIRF). The TIRF provides rapid, sensitive, simultaneous, and cost-effective detection of multiple biochemical targets with minimal sample preparation. This EAGER proposal seeks funding to explore the feasibility of modifying an existing technology developed by MBio Diagnostics, Inc., consisting of a cartridge and reader system in order to achieve either a smaller form factor, an increased sample capacity, or both. This modified TIRF technology will be designed for integration with an AUV-based sample acquisition/processing module that will provide for underway generation of biological data in support of oceanographic applications.

Broader Impacts:

The TIRF-based sensor is one of several emerging technologies that promise to transform ocean science by providing the ability to carry out interactive experiments and test hypotheses remotely at the molecular level. It has the potential for providing real or near-real time data revealing not only species? presence and abundance, but also the metabolic and physiological status of those organisms at the biochemical and molecular levels, can provide new insights into how populations are responding in situ to their environment over time as conditions change. This project will continue to build international collaborations with the UK and Ireland. It will include 4 undergraduate and 3 graduate student participation in both the US and Ireland. A workshop will be organized in Belfast as well as using these development experiences as part of an on-line module for a Masters in Diagnostics (University Arizona).


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.64M | Year: 2012

DESCRIPTION (provided by applicant): The overall goal of this project is to develop and commercialize a simple cell counter for routine enumeration of CD4 cells for management of HIV-infected individuals. HIV-1 mediated CD4 cell destruction is the centralimmunologic feature of HIV-1 infection. Thus, the CD4 count is a critical measurement in initial disease staging, in monitoring antiretroviral therapy and in managing primary and secondary prophylaxis for opportunistic infections. Flow cytometry is the current standard-of-care for CD4 cell counting. Unfortunately, flow is a central lab-based technique, and sample cold chain and transport, equipment, and operational costs render the technique cost-prohibitive in limited resource settings where HIV prevalence is highest. A simple, point-of-care (POC) CD4 counting tool will fundamentally change HIV-1 management. The first phases of this project have yielded a low-cost prototype instrument that delivers fast, accurate, and reliable CD4 counts for whole blood specimens from both HIV-infected individuals and healthy donors. Building on this success, we propose to complete the technical development by minimizing required user interactions with the device, driving toward an FDA CLIA-waived system. The specific aimsare: 1. Simplify the sample processing protocol and design and build a cartridge/instrument prototype for which the only user interaction is whole blood addition. We will investigate and develop assay reagent combinations (e.g., stain, lysis buffer,etc.), reagent packaging, and modified disposable cartridge and instrument designs to reduce the number of liquid transfer steps in the assay. The development goal is a CLIA-waived (or equivalent) system. 2. Incorporate in-cartridge quality controlsthat confirm correct function and user operation. We will develop a combination of calibration kit components and on-cartridge quality control features, including count calibrators, fluorescent stain indicators and image quality software flags. 3. Demonstrate the accuracy and usability of the CD4 counting system in clinical settings. Field evaluations of the prototype system will be performed at HIV-specific clinics affiliated with the University of California, San Diego (UCSD) Medical Center and in Maputo, Mozambique. Supporting this effort we have established strong clinical collaborations with global health thought leaders. Co-investigators Dr. Robert Schooley and Dr. Constance Benson at UCSD provide critical input on device requirements, andfacilitate laboratory evaluations. At the conclusion of this project, the utility, value, and unique capabilities of the MBio point of care C4 cell counter will be strongly established, and the final steps in commercialization, i.e., productin instruments,clinical trials, regulatory submission, and marketing will be accelerated. PUBLIC HEALTH RELEVANCE: HIV/AIDS remains a critical public health concern worldwide. It is estimated that by 2014, 12 million people will need access to affordable, point-of-care CD4 cell count measurements to effectively manage their HIV infection. The proposed research is aimed directly at providing this key medical technology.

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