IP Library Granted Patent US 7,361,517
Granted Patent B2
US 7,361,517 · App. 11/101,898 · Granted Apr 22, 2008

Real time method of detecting acute inflammatory conditions

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Quick Facts
Patent No.
US 7,361,517
App. No.
11/101,898
Granted
Apr 22, 2008
Kind
B2
Abstract

This invention relates to the diagnosis and/or monitoring of patients with inflammatory diseases or conditions, including systemic lupus erythematosus, particularly for diagnosis of the acute stage of the disease, including methods and kits for carrying out this activity. This disclosure presents the surprising discovery that levels of complement pathway components on reticulocytes can be used to diagnose, monitor, or predict the occurrence of acute episodes of chronic inflammatory diseases or conditions.

Claims (21)

1. A method for diagnosing an acute inflammatory episode of systemic lupus erythematosus (SLE) in an individual, the method comprising:

(a) isolating reticulocytes from a blood sample of an individual;

(b) determining the level of a C4d complement pathway component on the isolated reticulocytes from the individual, and

(c) comparing the C4d complement pathway component level on the isolated reticulocytes from the individual with a control level of C4d complement pathway component on reticulocytes, wherein an elevated level of the C4d complement pathway component on the isolated reticulocytes in the individual compared to the control level of the C4d complement pathway component on reticulocytes indicates that the individual has the acute inflammatory episode of SLE.

2. The method of claim 1 , wherein the level of the C4d complement pathway component is determined using an antibody specific for the C4d complement pathway component.

3. The method of claim 2 , wherein the C4d antibody is labeled.

4. The method of claim 3 , wherein the C4d antibody is detected using flow cytometric analysis.

5. A method of predicting an acute inflammatory episode of systemic lupus erythematosus (SLE) in an individual, the method comprising:

(a) isolating reticulocytes from a blood sample of an individual;

(b) determining the level of a C4d complement pathway component on the isolated reticulocytes from the individual, and

(c) comparing the C4d complement pathway component level on the isolated reticulocytes from the individual with a control level of complement pathway component on reticulocytes, wherein an elevated level of the C4d complement pathway component in the isolated reticulocytes in the individual compared to the control level of the C4d complement pathway component on reticulocytes is predictive of an acute inflammatory episode of SLE.

6. The method of claim 5 , wherein the level of the C4d complement pathway component is determined using an antibody specific for the C4d complement pathway component.

7. The method of claim 6 , wherein the C4d antibody is labeled.

8. The method of claim 7 , wherein the C4d antibody is detected using flow cytometric analysis.

9. A method for monitoring the clinical course of an acute inflammatory episode of systemic lupus erythematosus (SLE), the method comprising:

(a) isolating reticulocytes from a blood sample of an individual at a first time point and at a second time point;

(b) determining the level of a C4d complement pathway component on the isolated reticulocytes of the individual at the first time point; and

(c) comparing the level of the C4d complement pathway component on the isolated reticulocytes of the individual at the first time point with the isolated reticulocytes of the individual at the second time point, wherein a change in the level of the C4d complement pathway component on the isolated reticulocytes from the first time point to the second time point of the individual indicates a change in the clinical course of the acute inflammatory episode of SLE in the individual.

10. The method of claim 9 , wherein the level of the C4d complement pathway component is determined using an antibody specific for the C4d complement pathway component.

11. The method of claim 10 , wherein the C4d antibody is labeled.

12. The method of claim 11 , wherein the C4d antibody is detected using flow cytometric analysis.

Assignments (9)
RELEASE OF SECURITY INTEREST Recorded Apr 25, 2025
From: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
To: EXAGEN INC.
Reel/Frame 070951/0040 →
SECURITY INTEREST Recorded Apr 25, 2025
From: EXAGEN INC.
To: PERCEPTIVE CREDIT HOLDINGS IV, LP
Reel/Frame 070952/0802 →
SECURITY INTEREST Recorded Sep 11, 2017
From: EXAGEN DIAGNOSTICS, INC.
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP, AS COLLATERAL AGENT
Reel/Frame 043548/0228 →
RELEASE OF SECURITY INTEREST Recorded Sep 7, 2017
From: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
To: EXAGEN DIAGNOSTICS, INC.
Reel/Frame 043784/0828 →
RELEASE OF SECURITY INTEREST Recorded Sep 1, 2017
From: CYPRESS BIOSCIENCE INC.
To: EXAGEN DIAGNOSTICS, INC.
Reel/Frame 043747/0382 →
SHORT-FORM PATENT SECURITY AGREEMENT Recorded Oct 15, 2013
From: EXAGEN DIAGNOSTICS, INC.
To: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Reel/Frame 031414/0660 →
SECURITY AGREEMENT Recorded Oct 12, 2010
From: EXAGEN DIAGNOSTICS, INC.
To: CYPRESS BIOSCIENCE, INC.
Reel/Frame 025126/0241 →
CONFIRMATORY LICENSE Recorded Aug 13, 2009
From: UNIVERSITY OF PITTSBURGH
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 023094/0214 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 15, 2005
From: AHEARN, JOSEPH M.; MANZI, SUSAN M.
To: UNIVERSITY OF PITTSBURGH
Reel/Frame 016543/0053 →