NEW YORK – Shares of CareDx surged this week following the weekend publication of a large peer-reviewed study that demonstrated the utility of the company's kidney transplant diagnostic product for improving the detection, characterization, and treatment of kidney allograft rejection.
In mid-Tuesday afternoon trading on the Nasdaq, the Brisbane, California-based firm's shares were up more than 5 percent at $14.12 after ticking up about 1 percent in Monday trading.
Led by researchers from the Paris Institute for Transplantation and Organ Regeneration and their collaborators in the US and Belgium, the international multicenter study, which was published as an accelerated unedited preview in Nature Medicine and timed with the 2024 American Transplant Congress, assessed the performance of CareDx's AlloSure donor-derived cell-free DNA (dd-cfDNA) test, a targeted next-generation sequencing assay for detecting allograft injury and rejection, as well as AlloView, the company's AI-based rejection risk prediction model.
The study enrolled 2,882 kidney allograft recipients from 14 transplantation centers in Europe and the US. The researchers conducted primary analysis on 1,134 patients with AlloSure Kidney dd-cfDNA levels and matched biopsy results while carrying out external validation in the rest of the participants, which included a cohort of more than 430 African American patients.
Overall, the study concluded that dd-cfDNA is "strongly correlated" with the presence, activity, and severity of all types of kidney-allograft rejection, including antibody-mediated rejection, T-cell-mediated rejection, and mixed rejection, beyond the standard-of-care patient monitoring parameters. In addition, the results demonstrated dd-cfDNA's "high predictive value" to detect subclinical rejection in stable patients, where standard-of-care biomarkers are lacking.
"This study underscores AlloSure dd-cfDNA's role as a real-time indicator of kidney transplant rejection, enabling clinicians to intervene earlier before rejection occurs and to monitor post-treatment progress without resorting to unnecessary biopsy procedures," Alexandre Loupy, director of the Paris Institute for Transplantation and Organ Regeneration and the corresponding author of the study, said in a statement.
"We believe that this is exactly the type of data that is needed to drive increased adoption, guideline inclusion, and expanded reimbursement," Bill Bonello, senior research analyst of investment bank Craig-Hallum, wrote in an analyst note on Tuesday. Craig-Hallum upgraded CareDx to a Buy rating in May.
The publication of the study has led to some recovery for CareDx's stock, which took a big hit last week after Natera asked for an injunction against the company as part of the ongoing patent litigation that alleges that CareDx had infringed certain Natera patents.
In a statement, CareDx said AlloView, an AI-based risk prediction model that "optimizes patient risk prediction by integrating artificial intelligence, AlloSure, and standard-of-care measures" is now commercially available.