CareDx Reiterates Position that it Does Not Infringe Natera's '544 Patent

Injunction Motion has No Impact on CareDx's Business or Patient and Clinician Access to AlloSure or AlloMap

CareDx, Inc. (NASDAQ:CDNA) – The Transplant Company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today responded to Natera, Inc.'s filing of a motion for an injunction related to patent 11,111,544 (the '544 patent).

The motion seeks to stop CareDx from using a prior AlloSure process that Natera alleged infringed the '544 patent. That process is no longer in effect. As CareDx informed Natera and the Court, since August 2023, CareDx has utilized a new AlloSure process that it believes does not infringe on the '544 patent.

The underlying validity of the '544 patent also remains subject to judicial review.

"We believe the motion against a process that is no longer in effect is irrelevant, and the District Court is still considering the fundamental question of the validity of the '544 patent," said John W. Hanna, CareDx President and CEO. "We greatly appreciate the continued support of the transplant community as we seek to resolve these matters, allowing us to return our full attention to serving patients and developing clinical innovations that improve transplant care."

Natera has previously claimed infringement on three patents:

1. Prior to trial, the District Court dismissed patent 10,597,724 (the '724 patent) as invalid as patent ineligible.
2. At trial, CareDx was found not to have infringed on patent 10,655,180 (the '180 patent).
3. The '544 patent is the subject of post-trial motion practice in which, among other things, CareDx is seeking to invalidate that patent on the same grounds as the '724 patent.

Natera's motion does not impact CareDx's business or ability to continue providing transplant patients with AlloSure or AlloMap.