We’re excited to share that Arkana has received a $266,613 Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to develop a new diagnostic test aimed at helping physicians make better treatment decisions for kidney transplant patients experiencing rejection.
The one-year project, Precision Diagnostics in T-cell Mediated Rejection: Predicting Treatment Resistance at Time of Diagnosis, is funded by the National Institute of Allergy and Infectious Diseases (NIAID).
Why this matters
T-cell mediated rejection, or TCMR, occurs when a transplant patient’s immune system attacks the transplanted kidney. While treatments are available, they fail in approximately 30–50% of cases.
The challenge is that physicians currently have no reliable way to know at the time of diagnosis which patients are likely to respond to standard treatment. Instead, treatment begins and physicians have to wait to see whether it works.
For patients whose rejection is resistant to treatment, this can mean receiving powerful immunosuppressive medications without the intended benefit. These treatments can carry significant risks, including serious infections and certain cancers.
Our goal is to give physicians better information from the start.
What we’re developing
Through previous NIAID-funded research, Dr. Shana Coley and the Arkana research team identified a pattern of 27 genes in kidney transplant biopsy tissue that can help predict whether TCMR will respond to standard treatment.
That discovery was made using whole transcriptome sequencing, a powerful research technology that is not practical for routine transplant care, where treatment decisions need to be made quickly.
With this Phase I award, the team will work to turn that discovery into a faster and more practical test using qPCR, a technology already widely used in molecular laboratories.
Over the next year, the team will:
- Develop a rapid qPCR-based test to measure the 27-gene signature using existing kidney biopsy tissue, with the goal of providing results within a single day.
- Build and evaluate a predictive model that uses those results to identify cases of TCMR that are likely to be resistant to standard treatment.
The ultimate goal is simple: give transplant physicians useful information at the time of diagnosis so they can make more informed treatment decisions for each patient.
What comes next
This Phase I project is the first step. If successful, the team plans to pursue Phase II funding to validate the test using additional patient samples and move it closer to clinical use.
The long-term goal is to offer the validated test through Arkana’s molecular diagnostics laboratory, creating a precision diagnostic tool that could help physicians tailor treatment and reduce unnecessary exposure to ineffective immunosuppression.
The team behind the project
Dr. Chris Larsen will serve as Principal Investigator. The project builds on research led by Dr. Shana Coley, who developed the original grant application and whose previous NIAID-funded work identified the gene signature underlying the proposed test.
Owen Stephens, Director of Arkana’s Clinical Biomarker Center, will serve as co-investigator and key personnel on this project. Owen has spent the last three years directly involved in identifying these biomarkers, and he’ll be the primary scientist carrying out the experimental work, including experiment design, data generation, data analysis, and reporting of results.
Congratulations to the team on this exciting award and the opportunity to continue moving Arkana research from discovery toward meaningful clinical application.
Research reported in this publication was supported by the National Institute Of Allergy And Infectious Diseases of the National Institutes of Health under Award Number R43AI197708. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Quick note: This post is to be used for informational purposes only and does not constitute medical or health advice. Each person should consult their own doctor with respect to matters referenced. Arkana Laboratories assumes no liability for actions taken in reliance upon the information contained herein.
