NEW YORK (GenomeWeb) – CareDx is planning to launch a new multi-modal kidney transplant diagnostic test, which will include its AlloSure blood-based donor-derived cell-free DNA test, its AlloMap gene expression test, and a predictive artificial intelligence algorithm from French medical technology firm and CareDx collaborator Cibiltech.
AlloSure, which is already used for kidney transplant monitoring, will be used in KidneyCare to monitor allograft rejection. The company is developing a new version of AlloMap — which was originally developed as a test to monitor heart transplants — specifically for kidney health and will use it in KidneyCare to monitor immune quiescence. And Cibiltech's iBox software algorithm will provide additional information about the graft's risk for rejection over three, five, and 10 years.
On a conference call with analysts following the release of the company's first quarter earnings report on Wednesday, CareDx CEO Peter Maag said that KidneyCare will officially be launched at the American Transplant Congress in Boston in June.
He called KidneyCare "the logical second example of our multi-modality testing" after the firm's launch of its HeartCare test in April 2018, which combined AlloMap with a version of AlloSure for the heart to give clinicians a holistic view into the health of heart transplant recipients and a clearer picture of patients' immune system activity and graft health.
"Overall, I think it's a significant contribution to transplant patients having cell-free DNA testing as an ongoing injury marker, then having AlloMap Kidney as an opportunity to measure immune activity, and then allograft prediction in terms of how long the allograft actually functions," Maag said. "We are very excited, as [KidneyCare] marks the next step in providing insight into organ injury and also provides the prognostic element of allograft survival at three years, five years, and 10 years. We are very excited about also applying gene expression profiling technology to the field of transplantation [with AlloMap Kidney]."
He noted that KidneyCare will likely be launched in the form of a clinical trial, with CareDx making it available to transplantation clinicians on a trial basis. Indeed, this would follow the company's model of rolling out a new version of one of its diagnostics while also performing clinical trials. In February, CareDx made AlloSure available to lung transplant patients under a compassionate use program while it conducted clinical studies to make AlloSure Lung an official part of its transplant diagnostic product portfolio.
"It's a cell-free DNA assay which is analytically validated, and which measures the donor-derived cell-free DNA as a percentage of the cell-free DNA from the recipient," Maag told GenomeWeb at the time, adding that the test could really be called a "pan-organ assay" because it detects the ratio of foreign cell-free DNA to own-body DNA, which is applicable in all solid organ transplantation settings.
On the conference call, Maag also discussed how CareDx plans to use its recent acquisition of transplant patient tracking software provider OTTR Complete Transplant Management and its partnership with Cibiltech to enhance its own diagnostic offerings.
OTTR software's will simplify the way transplant centers order AlloSure and AlloMap, and will allow for the integration of CareDx's surveillance software into patients' electronic medical records, he said, adding that it provides a "backbone" for an AI data analysis infrastructure.
That AI infrastructure will start with Predigraft, a data analysis tool that CareDx and Cibiltech have agreed to commercialize together, which provides an early prediction of an individual's risk of allograft rejection and transplant loss.
"Predigraft data analysis represents the start of being able to use data to stratify transplant patients based on the risk for long-term outcomes," Maag said. "Our goal is to add smart analytics and machine learning to provide artificial intelligence solutions in transplantation. Our large clinical datasets collected through our registry studies will provide caregivers with point-of-care decision-making support tools that allow them to stratify their patient population."
Maag did note that although OTTR's software could easily be dropped into a few US transplant centers, it will likely take CareDx "quarters and quarters" to adapt AlloSure and AlloMap testing or functionality for the software with a simple mouse click.
In a note to investors on Thursday, Jefferies analyst Brandon Couillard wrote that CareDx is "putting a bear hug around transplant centers." Although more real-world data is needed before the company attempts a full roll-out of KidneyCare, the test's multi-modal nature would not only set the company apart from the competition, Couillard noted, but it could also be very valuable for organ waitlist management efforts, which would provide CareDx with new revenue opportunities.
In his own note to investors, Piper Jaffray's William Quirk added that if KidneyCare offers additional actionable information over and above what doctors receive from AlloSure testing, "we believe it could further differentiate CareDx's post-transplant offering and expect this will likely be rolled out into future solid organ tests (such as liver)."