Datirium LLC

Bioinformatics Pipeline for Personalized Diagnostics of Transplant Rejection - Summary Transplantation Is the Most Effective Treatment for Kidney Failure, Providing Improved Survival and Quality of Life. in the Us, ~20,000-25,000 Kidney Transplants Are Performed in the Us Per Year. Roughly ~90,000 Individuals Are Waitlisted to Receive a Kidney Allograft With Average Waiting Time ~5 Years. Many Individuals Die Before Receiving the Transplant. Those Patients Receiving a Transplant Are Required to Be on Life-long, Maintenance Immunosuppression (MIS) With Calcineurin Inhibitors (cni), Such as Tacrolimus, to Prevent Rejection. Unfortunately, Rejection Still Remains the #1 Cause of Death-censored Graft Loss. Potential Treatment for Graft Failure Is Dialysis ($126K/YEAR)1 or Another Transplant (~$500K) If Another Compatible Kidney Is Available. Overall, in the Us the Annual Cost of Kidney Transplant Failure Is $1.3B With ~ Half Covered by MEDICARE2. Thus, Even a Minor Decrease in Graft Loss Carries a Potential for Enormous Human and Economic Benefit. Our Preliminary and Published Data Show That the Scrna/vdj Analysis of Kidney Biopsies and Potentially Urine Samples Can Identify the Alloreactive Expanded Cytotoxic T Cell Clones (CD8EXP) That Are Likely Causing Rejection. We Also Showed That the Analysis of Gene Expression in These Clones Can Identify Targets for Anti- Rejection Therapy. the Aim of the Project Is to Develop a Diagnostic Test Based on Scrna/vdj Analysis That Will Help Physicians Select Personalized Anti-rejection Therapy Based on the Phenotype of the Cells Causing Rejection. in This Phase I Project, We Aim to (i) Develop an Automated Computational Pipelines That Will Process the Data and Produce a Report for Treating Physician and (II) to Demonstrate the Feasibility of Completing the Test Within Clinically Reasonable Time-frame. We Will Also Collect Preliminary Data That Will Help Justify a Larger Phase Ii Study That Will Demonstrate the Clinical Benefit of the Test.