Organ transplant recipients have a 200-fold increased incidence of keratinocyte carcinoma compared with immunocompetent individuals, and cSCC accounts for 80% of skin cancers in those recipients.
CareDx is the exclusive licensee of U.S. Patents 8,703,652, 9,845,497, and 10,329,607 entitled "Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients" owned by Stanford.
In CareDx, Inc. v. Natera, Inc., Court of Appeals for the Federal Circuit held CareDx’s patent claims to methods of detecting organ transplant rejection were invalid as patent ineligible under 35 U.S.C. section 101. Claims to medical diagnostics face unique challenges.
In CareDx, Inc. v. Natera, Inc., No. 2022-1027 (Fed. Cir. July 18, 2022), the Federal Circuit Court of Appeals affirmed that CareDx's three patents were invalid for claiming patent-ineligible subject matter.
The Cardiac Rejection Assessment Neural Estimator (CRANE) could help clinicians more accurately diagnose rejection and estimate its severity in endomyocardial biopsies.