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CareDx, NanoString Collaborate to Develop Organ Transplant Rejection Test

NEW YORK – Organ transplant diagnostics company CareDx announced today that it has formed a strategic partnership with NanoString Technologies to develop HistoMap, a gene expression profiling test to identify allograft rejection in transplant biopsy tissue.

Under the terms of the agreement, CareDx will combine its expertise and transplant registries with NanoString's nCounter platform, and its newly introduced Human Organ Transplant panel — a 770-gene panel designed to evaluate human immune response following organ transplantation.

NanoString announced the launch of the nCounter Human Organ Transplant panel yesterday. The test was created by NanoString, and the Banff Foundation for Allograft Pathology, a global consortium of six transplant institutes, including the University of Alberta, Erasmus Medical Center Rotterdam, Imperial College London, Massachusetts General Hospital, the University of Oxford, and the Paris Transplant Group. The Banff consortium aims to improve organ transplant outcomes through molecular characterization of the in situ response in the allograft.

The Human Organ Transplant Panel uses the ease and rapid time-to-results of the nCounter platform to provide a standardized panel that the research community may use to develop new biomarker signatures for transplant health, NanoString said.

The customizable 770-gene expression panel is specifically for use with kidney, heart, lung, and liver transplantation, and includes genes across 37 different pathways, as well as components of the immune response, tissue injury, and mechanisms of action for immunosuppressive drugs. It also includes probes to detect common viral infections that are common in transplantation, including BK polyomavirus, cytomegalovirus, and Epstein-Barr virus.

"This partnership will further enhance the development of molecular assays in transplantation and help to improve transplant diagnostics," University of Alberta researcher Michael Mengel said in a statement. "The Banff classification has already integrated recommendations for use of molecular diagnostics in diagnosing transplant rejection, and tools like HistoMap can enhance and help standardize the diagnostic process with the goal to advance patient management, guide therapy, and improve outcomes."

HistoMap builds on CareDx's AlloMap and AlloSure franchises, added CareDx CEO Peter Maag, and "will add to CareDx's commitment to improving patient outcomes through multimodality testing."

In May, CareDx announced plans 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.