Abstract: Aspects of the present invention include methods for determining a transplant category of a subject having a transplant. Common mechanisms of rejection injury are uncovered across different tissue transplants, and provide a means to understand rational drug design. Various sources of tissues are examined form the patient for understanding AR mechanism (graft biopsy), as well as monitoring by minimal invasive means (blood) or non-invasive means (urine for the kidney allograft). For biomarker discovery different categories of markers are examined such as genes, proteins, peptides and antibodies. These biomarkers can help determine the subject's transplant category (e.g., acute allograft rejection (AR), stable allograft (STA), BK viremia, BK nephritis, drug toxicity or chronic allograft injury (CAI), and the like). Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: Herein are novel methods of detecting subacute and active rejection in graft recipients, including kidney recipients by the measurement of donor-derived cell-free DNA. By the methods, active rejection processes encompassing T-cell mediated rejection may be detected. Also provided herein are novel threshold values for the determination of active rejection that enable higher sensitivity and specificity than prior methods. Additionally, by donor-derived cell-free DNA, subacute rejection processes can be detected, including borderline rejection and other graft injuries.

Abstract: Aspects of the present invention include methods for determining a transplant category of a subject having a transplant. Common mechanisms of rejection injury are uncovered across different tissue transplants, and provide a means to understand rational drug design. Various sources of tissues are examined form the patient for understanding AR mechanism (graft biopsy), as well as monitoring by minimal invasive means (blood) or non-invasive means (urine for the kidney allograft). For biomarker discovery different categories of markers are examined such as genes, proteins, peptides and antibodies. These biomarkers can help determine the subject's transplant category (e.g., acute allograft rejection (AR), stable allograft (STA), BK viremia, BK nephritis, drug toxicity or chronic allograft injury (CAI), and the like). Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: Provided herein are methods, compositions, and kits for diagnosing allograft rejection of organ transplants by identifying the presence of anti-endothelial cell antibodies. Such methods and compositions are independent of external confounders such as recipient age, transplant center, assay, cause of end-stage disease, co-morbidities, immunosuppression usage, and the like.

Abstract: Aspects of the present invention include methods for determining a transplant category of a subject having a transplant. Common mechanisms of rejection injury are uncovered across different tissue transplants, and provide a means to understand rational drug design. Various sources of tissues are examined form the patient for understanding AR mechanism (graft biopsy), as well as monitoring by minimal invasive means (blood) or non-invasive means (urine for the kidney allograft). For biomarker discovery different categories of markers are examined such as genes, proteins, peptides and antibodies. These biomarkers can help determine the subject's transplant category (e.g., acute allograft rejection (AR), stable allograft (STA), BK viremia, BK nephritis, drug toxicity or chronic allograft injury (CAI), and the like). Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: Aspects of the present invention include methods for determining a transplant category of a subject having a transplant. Common mechanisms of rejection injury are uncovered across different tissue transplants, and provide a means to understand rational drug design. Various sources of tissues are examined form the patient for understanding AR mechanism (graft biopsy), as well as monitoring by minimal invasive means (blood) or non-invasive means (urine for the kidney allograft). For biomarker discovery different categories of markers are examined such as genes, proteins, peptides and antibodies. These biomarkers can help determine the subject's transplant category (e.g., acute allograft rejection (AR), stable allograft (STA), BK viremia, BK nephritis, drug toxicity or chronic allograft injury (CAI), and the like). Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: The present invention relates to non-invasive tools and methods for evaluating renal status and renal health using urine cell free DNA.

Abstract: Aspects of the present invention include methods for diagnosing and monitoring IgAN in a subject. In practicing one aspect of the subject methods, a sample from a subject is analyzed for the presence of one or more specific autoantibodies to determine the IgAN phenotype of the subject. Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: Aspects of the present invention include methods for diagnosing and monitoring IgAN in a subject. In practicing one aspect of the subject methods, a sample from a subject is analyzed for the presence of one or more specific autoantibodies to determine the IgAN phenotype of the subject. Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: Methods are provided for determining whether a subject has a diabetes phenotype. In practicing the subject methods, a sample, e.g., a blood sample, from a subject is analyzed for the presence of one or more autoantibodies to obtain an antibody signature. The obtained antibody signature is then employed to determine whether the subject has a diabetes phenotype. The subject methods may be used in diagnostic or prognostic applications, e.g., determining whether the subject has diabetes (e.g., T1D or T2D), or monitoring a subject with diabetes to determine whether the subject has or will develop ESRD. Also provided are compositions, systems and kits that find use in practicing the subject methods. The subject methods and compositions find use in a variety of applications, including the diagnosis and monitoring of diabetes in a subject.

Abstract: Aspects of the present invention include methods for determining a transplant category of a subject having a transplant. Common mechanisms of rejection injury are uncovered across different tissue transplants, and provide a means to understand rational drug design. Various sources of tissues are examined form the patient for understanding AR mechanism (graft biopsy), as well as monitoring by minimal invasive means (blood) or non-invasive means (urine for the kidney allograft). For biomarker discovery different categories of markers are examined such as genes, proteins, peptides and antibodies. These biomarkers can help determine the subject's transplant category (e.g., acute allograft rejection (AR), stable allograft (STA), BK viremia, BK nephritis, drug toxicity or chronic allograft injury (CAI), and the like). Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods. The methods and compositions find use in a variety of applications.

Abstract: Methods are provided for determining a transplant category of a subject having a kidney graft. In practicing one aspect of the subject methods, the peptide signature of a non-invasive sample derived from the transplant subject (e.g., a urine sample) is used to determine the subject's transplant category (e.g., acute allograft rejection (AR), stable allograft (STA), BK virus nephropathy (BK), and the like). In other embodiments, a gene expression signature from a biopsy sample from the subject (e.g., mRNA level) is used to determine the subject's transplant category. In certain embodiments both a peptide signature and a gene expression signature are used. Also provided are compositions, systems, kits and computer program products that find use in practicing the subject methods.

Abstract: Methods are provided for monitoring an allograft recipient for a rejection response, e.g., to predict, to diagnose, and/or to characterize a rejection response. In practicing the subject methods, the level of at least one protein in a sample from the allograft recipient, e.g., serum, urine, blood, CSF, tears or saliva, is evaluated, to monitor the subject. Also provided are compositions, systems, and kits that find use in practicing the subject methods.