Methods and compositions for diagnosing and monitoring the status of transplant rejection and immune disorders

• US 7,993,832 B2
• Filed: 08/14/2007
• Issued: 08/09/2011
• Est. Priority Date: 08/14/2006
• Status: Active Grant

• Current Assignee: CareDx, Inc.
• Original Assignee: XDx Incorporated
• Inventors: Wu, Bin, Dedrick, Russell L., Rosenberg, Steven, Fry, Kirk
• Primary Examiner(s): Horlick; Kenneth R.
• Assistant Examiner(s): Tung; Joyce
• Application Number:
  US11/893,236
• Publication Number:
  US 20080038746A1
• Time in Patent Office: 1,456 Days
• Field of Search: 435/7.1, 435/6
• US Class Current: 435/6.11
• CPC Class Codes: G01N 2800/24 Immunology or allergic disorders SLE G01N2800/104
• CPC Class Codes: G01N 2800/245 Transplantation related diseases, e.g. graft versus host disease
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

The invention presents methods of using splice variants and reagents thereof for diagnosing and monitoring the status of transplants and immune disorders including diagnosing, monitoring and predicting transplant rejection or non-rejection, steroid responsiveness, and onset or flare of immune disorders.

Claims

1. A method for diagnosing or monitoring the status of a transplant comprising:

(a) selecting a splice variant of a gene, wherein the splice variant comprises a sequence identified by a National Center for Biotechnology Information (NCBI) GI Number selected from the group consisting of 4504098, 56790928, 20135745, 27894332, 13551602, 50539411, 15758908, 33946272, 48255936, and 32481204;

(b) detecting expression of the splice variant in a sample using a probe that specifically detects the expression of the splice variant; and

(c) diagnosing or monitoring the status of the transplant based on the expression of the splice variant in the sample.

2. The method of claim 1, wherein the transplant is an allograft selected from the group consisting of an artificial organ, a mechanical organ, bone marrow, a cornea, a heart, a kidney, a liver, a lung, an organ-system, a pancreas, pancreatic islet cells, stem cells, skin tissue, skin cells, and a xenotransplant.

3. The method of claim 1, wherein the transplant is a heart allograft.

4. The method of claim 1, wherein diagnosing or monitoring the status of a transplant comprises diagnosing or monitoring acute cellular rejection.