CareDx Announces Cibiltech Initiates CIBIL Study Using iBox Artificial Intelligence to Monitor Kidney Transplant Patients

Rhea-AI Summary

CareDx announces the initiation of the CIBIL clinical trial in partnership with Cibiltech to assess the iBox AI algorithm for kidney transplant patient management. The trial aims to include 450 patients to evaluate the clinical and economic benefits of iBox in predicting organ survival. CareDx is a minor stakeholder in Cibiltech and holds exclusive commercialization rights for iBox in the U.S. The company is also leveraging iBox within its OKRA study, enhancing its suite of transplant monitoring tools.

Positive

• Initiation of the CIBIL clinical trial to assess iBox AI for organ survival prediction.
• Potential inclusion of 450 patients in the CIBIL trial enhances research credibility.
• CareDx's exclusive rights to commercialize iBox in the U.S. could positively impact market presence.
• iBox is validated for predicting graft survival, potentially improving patient outcomes.

Negative

• None.

Results from CareDx’s OKRA Study and Cibiltech’s CIBIL Study will Demonstrate Clinical Utility of iBox for Transplant Patient Management

SOUTH SAN FRANCISCO, Calif., March 03, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that its strategic partner, Cibiltech, a French MedTech company that develops artificial intelligence-based products for predictive medicine, has initiated the CIBIL clinical trial to evaluate the performance of iBox artificial intelligence (AI) as a prognostic measure of organ survival in kidney transplant patients.

The CIBIL “Clinical Impact of the iBox as an Early Intervention tooL” trial is a prospective randomized controlled trial being conducted internationally with 450 patients to evaluate the clinical and health economic benefits of using iBox to predict allograft survival in the follow-up of kidney transplanted patients (NCT05112315). iBox has been previously validated by the Paris Transplant Group in a seminal AI paper for transplantation in the British Medical Journal.¹

“The CIBIL trial represents a key milestone in CareDx’s partnership with Cibiltech as we continue to evolve our multimodality pipeline with iBox and its prognostic capabilities to assess organ graft survival,” said Reg Seeto, CEO and President of CareDx. “We are seeing the benefits of incorporating AI into our OKRA study, which includes the iBox technology as a predictive tool alongside multimodality testing with our AlloSure® and AlloMap® services. We look forward to the results of both CIBIL and OKRA, and to making iBox more widely available to clinicians in the United States as an additional clinical tool.”

CareDx is a minority owner of Cibiltech and holds exclusive rights to commercialize iBox in the United States. iBox is an algorithm developed by the Paris Transplant Group, which determines the probability of graft survival three, five, and seven years after evaluation. The OKRA (Outcomes of KidneyCare in Renal Allografts) is a multicenter, prospective, observational registry designed to measure outcomes of kidney transplant recipients managed with CareDx’s multimodality assessment of graft health including AlloSure donor-derived cell-free DNA (dd-cfDNA), AlloMap kidney gene expression profiling, and prognostic graft assessment using iBox.

“We are excited to initiate the CIBIL study to assess the clinical and health economic benefits of using the iBox AI algorithm as an early intervention monitoring tool for kidney transplant patients worldwide,” said Stephane Tholander, CEO of Cibiltech. “We look forward to continuing our partnership with CareDx to incorporate iBox into its pipeline of offerings so that clinicians have additional tools to help improve long-term transplant health outcomes.”

About CareDx – The Transplant Company
CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with iBox, Cibiltech’s CIBIL clinical trial, and CareDx’s OKRA study. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of the iBox or the OKRA study; risks that Cibiltech does not realize the expected benefits of the CIBIL clinical trial; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed by CareDx with the SEC on February 24, 2022, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS:

CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com

Investor Relations
Ian Cooney
(415) 722-4563
investor@caredx.com

References:

1. Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, et al. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ 2019; 366: l4923. doi: https://doi.org/10.1136/bmj.l4923 
   

FAQ

What is the CIBIL clinical trial related to CDNA?

The CIBIL clinical trial evaluates the performance of the iBox AI algorithm in predicting organ survival in kidney transplant patients.

How many patients are involved in the CIBIL trial by CDNA?

The CIBIL trial aims to include 450 patients to assess the clinical benefits of the iBox AI algorithm.

What rights does CDNA hold regarding the iBox technology?

CareDx holds exclusive rights to commercialize the iBox AI technology in the United States.

How is CDNA incorporating iBox in its OKRA study?

CareDx is incorporating iBox as a predictive tool alongside its AlloSure and AlloMap services in the OKRA study.