Collaboration to develop cfDNA reference standards, 8/15

CareDx and Horizon Discovery Group will collaborate to develop cell-free DNA reference standards. The HDx Reference standards, being developed by Horizon Diagnostics, will support proficiency testing of CareDx’s solid organ transplant injury monitoring diagnostic tests and will be integrated into CLIA laboratory testing.

HDx Reference standards offer a source of genetically defined, quantitative, sustainable, and independent third-party reference material for the validation and routine performance monitoring of CareDx’s next-generation-sequencing–based donor-derived cfDNA diagnostic assay. The reference standards mimic plasma cfDNA in size and abundance in a transplant setting.

Horizon Diagnostics uses its proprietary genome engineering platforms to engineer highly characterized parental cell lines and then generates mixtures at very precise allelic frequencies, verified by digital PCR, ranging between 0.1 percent and 50 percent.

CareDx’s cfDNA test is designed to monitor injury to transplanted organs, in particular heart and kidney in transplant recipients, to allow clinicians to better manage patient health outcomes.

CareDx, 415-287-2300

Horizon Diagnostics, 844-655-7800