Methods, Systems, and Compositions for Diagnosing Transplant Rejection
AssigneesNorthwestern University, Transplant Genomics, Inc., The Scripps Research Institute
InventorsJohn Friedewald, Michael M. Abecassis, Rohita Sinha, Sook Hyeon Park, Lihui Zhao, Juston Weems, Sunil M. Kurian, Steve Kleiboeker
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Abstract
Described herein are methods, compositions, and systems useful for detecting transplant rejection and associated abnormal conditions in solid organ transplant recipients, such as kidney transplant recipients. Methods described herein may involve combined assessment of blood gene expression profiles from an assessment of particular, related mRNA transcript levels and donor-derived cell-free nucleic acids (dd-cfDNA).
Claims19
A method of distinguishing rejection from non-rejection in a kidney transplant recipient, the method comprising
- a. obtaining a blood, plasma, or serum sample from the kidney transplant recipient;
- b. obtaining cell-free DNA (cfDNA) and mRNA from the sample;
- c. determining (i) the level of donor derived cell-free DNA (dd-cfDNA) in the cfDNA and (ii) the expression level of at least one mRNA transcript, wherein the at least one mRNA transcript shows significantly different expression levels in kidney transplant rejection compared to kidney transplant non-rejection subjects;
- and
- d. distinguishing rejection from non-rejection in the recipient based upon results from both the dd-cfDNA and the expression level of at least one mRNA transcript, wherein rejection in the recipient is indicated by either or both of (i) a level of dd-cfDNA at or above a pre-determined threshold value, and (ii) result of a trained algorithm based on the expression level of the at least one mRNA transcript indicating rejection or non-rejection, wherein the algorithm compares the expression profile of the at least one mRNA transcript of the recipient to the expression profile of kidney transplant subjects with and without rejection.
Dependencies are inferred from the claim text.