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Device, Array, And Methods For Disease Detection And Analysis

a disease detection and analysis technology, applied in the field of biological and chemistry, can solve the problems of limiting application at the poc, not being able to detect breast cancer with any single marker, and not being able to identify breast cancer single markers

Inactive Publication Date: 2008-08-21
LAWRENCE LIVERMORE NAT SECURITY LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, while these biomarkers have shown some potential for possible specific detection of ovarian and colon cancers, no single marker has yet been identified for breast cancer.
This can be due to the fact that breast cancer is not a single disease, but a genetically heterogeneous set of diseases, thus suggesting that it can not be possible for breast cancer to be diagnosed with any single marker.
Multiplexed LFAs, although sensitive and specific, require elaborate imaging devices for sensitive quantification, thus limiting application at the POC.
These assays demonstrate better multiplexed sensitivities as compared to the LFAs, however, they involve sequential detection along the length of the strip rather than simultaneous detection, which limits the number of biomarkers that can be simultaneously analyzed due to the number of capture zones that can be created along the length of the strip.
Also, the fluid exchange through the channels was achieved using a peristaltic pump, and the assay involved multiple incubation and wash steps, making it challenging to automate and reduce this device to a small, rugged portable form.

Method used

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  • Device, Array, And Methods For Disease Detection And Analysis
  • Device, Array, And Methods For Disease Detection And Analysis
  • Device, Array, And Methods For Disease Detection And Analysis

Examples

Experimental program
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example 1

Development of Multiplexed Assays

[0133]A multiplexed immunoassay for the measurement of breast cancer biomarkers using the protein microarray format was developed.

[0134]Protein microarrays have the potential to be used to simultaneously analyze large numbers of serum proteins in a rapid and reproducible manner. In recent years, protein microarrays have evolved as powerful tools to address high-throughput requirements by performing “traditional” biochemistry in an ultra-high-throughput and miniaturized format. On protein microarrays, purified capture molecules are immobilized in unique locations on the surface of the substrate that allow for recognizing the target under study. Since each capture molecule is immobilized in a precise, predetermined spot, the protein microarrays achieve multiplexing capability based on this unique location of the capture molecule and therefore the target protein bound to it (assuming high specificity of the antibody-antigen reaction). In the case of a r...

example 2

Sensitive Multiplexed Diagnostic Test for Breast Disease

[0180]The multiplexed protein microarray assay developed previously is applied to the differential detection of four biomarkers in breast cancer patient sera.

[0181]Materials and Methods

[0182]Microarray assay reagents and protocols are essentially similar to those described above in Example 1. Recombinant proteins, capture and biotinylated detection antibodies for Her-2, MMP-2 and Osteopontin were purchased from R&D systems (Minneapolis, Minn.). Other reagents used in the assay include: VEGF antigen and capture and biotinylated detection antibodies (Biosource International Camarillo, Calif.), CA 15-3 antigen and anti-CA 15-3 capture and detection antibodies (Fitzgerald, Concord, Mass.). The CA 15-3 detection antibody was biotinylated using a kit and according to the manufacturer's (Pierce, Rockford, Ill.) instructions. All other detection antibodies were purchased as biotin conjugates. Lyophilized human serum was purchased from ...

example 3

Development of a Multiplexed Flow-Based Detector

[0207]A flow based platform was built with a unique custom flow channel device onto which, the multiplexed assay was translated from the protein microarrays. Below, the development of the device is described. A new flow-based immunoassay system for the simultaneous and rapid quantification of multiple analytes without several processing steps is described. This example also discusses the details of the device design, which is based on the standard microarray sandwich immunoassay format, except that the static incubation step was replaced with flow of the analyte mixture over the antibody array. Multiple steps have also been eliminated (including washing) by mixing all the assay reagents in predetermined concentrations in one single sample. In addition, a benchtop version of a portable imaging system was developed, comprising a miniature uncooled CCD camera and a Xenon arc lamp. This method demonstrated rapid quantitative measurement an...

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Abstract

A device and array coupled to capture molecules are provided. Specifically, the device and array can be used for detecting the presence and concentration of biomarkers in a sample from a subject. The device and array can also allow the use of a method for scoring a sample for, e.g., the purpose of diagnosing a disease. The method can also be advantageous to applications where there is a need to accurately determine the disease stage of a subject for the purpose of making therapeutic decisions.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 60 / 902,147, filed Feb. 15, 2007, the entire disclosure of which is hereby incorporated by reference in its entirety for all purposes.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]The United States Government has rights in this invention pursuant to Contract No. DE-AC52-07NA27344 between the United States Department of Energy and Lawrence Livermore National Security, LLC for the operation of Lawrence Livermore National Laboratory.BACKGROUND[0003]1. Field of the Invention[0004]The invention relates to the fields of biology and chemistry.[0005]2. Description of the Related Art[0006]Research over the past decade has focused on discovering new biomarkers that provide accurate diagnosis of disease, guide therapeutic decision making, and predict the future patterns of disease. Cancer antigen (CA)-125 and Carcinoembryonic antigen (CEA) have both shown p...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C40B30/04C40B60/12C40B30/00
CPCB01J19/0046B01J2219/00385B01J2219/00549B01J2219/00612B01J2219/00621B01J2219/00626G01N33/543B01J2219/00725B01L3/5025B01L3/5027B01L3/50273C40B60/12B01J2219/00637
Inventor RAO, RUPA S.LANE, STEPHEN M.MATTHEWS, DENNIS L.COLEMAN, MATTHEW A.
Owner LAWRENCE LIVERMORE NAT SECURITY LLC
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