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CareDx, Veracyte to Commercialize Organ Transplant Rejection Tests on nCounter Platform

NEW YORK – CareDx and Veracyte said on Thursday that they have signed an agreement to make CareDx the exclusive worldwide commercialization partner for solid organ transplant rejection tests on Veracyte's nCounter Flex Analysis diagnostic platform.

In September 2019, CareDx said that it had formed a strategic partnership with NanoString Technologies to develop HistoMap, a gene expression profiling test to identify allograft rejection in transplant biopsy tissue, on the nCounter platform. In December, Veracyte announced that it had taken an exclusive global license to the nCounter platform for diagnostic use for $60 million. The new agreement with CareDx will expand the menu of genomic tests Veracyte offers on the nCounter instrument for the first time since it acquired the rights to the platform.

HistoMap will now run on the nCounter Flex Analysis System and will be developed using the Human Organ Transplant panel from the Banff Foundation for Allograft Pathology. 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. CareDx will be responsible for the global commercialization of HistoMap, the companies said.

Financial terms of the collaboration were not disclosed.

"With HistoMap added to our strong KidneyCare and HeartCare offerings, we will ensure that biopsies performed are reproducibly clinically relevant. This fits well into our approach of multimodality testing and patient stratification," CareDx Chairman and CEO Peter Maag said in a statement. "We are glad to partner with Veracyte to make these solutions available for transplant patients."

Veracyte Chairman and CEO Bonnie Anderson added that the deal will also help to broaden the installed base of nCounter instruments and increase adoption of Veracyte's tests around the world.