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Biomarker signatures and uses thereof

a biomarker and signature technology, applied in the field of biomarkers, can solve the problems of insufficient diagnosis, inability to solve key unmet clinical problems, and inability to use multiplexed serum biomarker signatures to achieve the goal of reducing the risk of lupus, and achieve good conjugate and good reaction colour

Inactive Publication Date: 2013-10-31
IMMUNOVIA AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent discusses the use of smaller antibody fragments, rather than whole antibodies, which have several advantages such as better pharmacological properties and easier production. The fragments can also be labeled with fluorescent or luminescent moieties that can be detected. The detection method uses enzymes that produce a colored reaction product. The patent also describes a specific method called an ELISA assay that involves using enzymes to amplify a phosphatase reaction. Overall, this patent describes a technology for improving the detection and characterization of antibodies and their fragments.

Problems solved by technology

Establishing a diagnosis of lupus is difficult and relies on a list of eleven classification criteria that were developed over twenty years ago by the American College of Rheumatology (ACR).
These classification criteria can guide the initial assessment of the patient with SLE but are not sufficient to adequately diagnose SLE, pin-point the phenotypic subclasses of SLE with high confidence, or to predict disease flares and remissions.
In fact, there currently exist no multiplexed serum biomarker signatures able to resolve these key unmet clinical issues.

Method used

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  • Biomarker signatures and uses thereof
  • Biomarker signatures and uses thereof
  • Biomarker signatures and uses thereof

Examples

Experimental program
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example b

Introduction

[0256]Serum profiling using antibody microarrays can facilitate our understanding of disease by identifying panels of disease-specific biomarkers, thereby enhancing our ability to diagnose and treat such diseases. Here, we performed a comprehensive survey of serologic proteome in human SLE using our in-house developed human recombinant single-chain fragment variable (scFv) microarray technology. We have indentified 20 serum biomarker signatures, that discriminates between SLE patients and healthy controls with a high specificity and sensitivity. When targeting the individual clinical subgroups of SLE we observed that differences in protein expression patterns depend on the activity and severity of the SLE symptoms. Serum proteome of patients with SLE glomerulonephritis (SLE3) showed the most significant difference compared to healthy one. Furthermore, the levels of some serum proteins, were highly correlated with clinical measure of disease activity (SLEDAI), as well as ...

example c

[0303]Systemic lupus erythematosus (SLE) is a potentially fatal autoimmune multisystem disease, characterized by chronic inflammations of various tissues and internal organs. The underlying mechanisms, not yet fully understood, involve immunological deficiencies as well as genetic, environmental and hormonal factors (1). Due to heterogeneous symptoms and an unpredictable course of disease, the management of SLE is one of the greatest challenges within the field of rheumatology (2).

[0304]Associated with poor long-term prognosis (3), SLE nephritis is one of the more severe manifestations of SLE that occurs in about 50% of all patients (1). Commonly, it is a result of antibody-antigen complex deposition in the glomerulus, i.e. the capillary network of the nephron, where the initial blood filtration takes place. These complexes activate the complement system which mediates local inflammatory events (4).

[0305]Standard treatment involves immunosuppressive agent cyclophosphamide. However, ...

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Abstract

The invention provides a method for determining a Systemic Lupus Erythematosus-associated disease state in a subject comprising the steps of (a) providing a sample to be tested; and (b) measuring the presence and / or amount in the test sample of one or more biomarker(s) selected from the group defined in Table 1, wherein the presence and / or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of a Systemic Lupus. The invention also provides an array and a kit suitable for use in the methods of the invention.

Description

FIELD OF INVENTION[0001]The present invention relates to biomarkers for the diagnosis, characterisation and prognosis of Systemic Lupus Erythematosus (SLE), as well as signatures and arrays thereof and methods for use of the same.BACKGROUND[0002]Systematic lupus erythematosus is a chronic, multisystem autoimmune disease with a broad range of possible clinical and serological presentations. It is characterized by a loss of tolerance to host antigens and development of pathogenic autoantibodies that damage target organs, such as skin, lungs, heart, joints, brain and kidney. SLE is estimated to worldwide affect 0.1% of the population, predominantly women between their 20s and early 40s. The pathogenesis of SLE is still largely unknown, although both genetic and environmental factors are probably involved in disease development. Establishing a diagnosis of lupus is difficult and relies on a list of eleven classification criteria that were developed over twenty years ago by the American ...

Claims

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Application Information

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IPC IPC(8): G01N33/564
CPCG01N33/564B82Y30/00G01N33/6893G01N2800/104G01N2800/60
Inventor BORREBAECK, CARL ARNE KRISTERWINGREN, LARS BERTIL CHRISTER
Owner IMMUNOVIA AB