This story has been updated to reflect a statement from Eurofins Viracor.
NEW YORK – CareDx announced today that it has filed a patent infringement lawsuit against Eurofins Viracor in the US District Court for Delaware, claiming that Eurofins has infringed on US Patent 8,703,652, which is exclusively licensed to CareDx from Stanford University.
Brisbane, California-based CareDx claims that the patent covers noninvasive monitoring of organ transplant rejection through cell-free DNA analysis, the basis of its AlloSure product. CareDx asserts that Eurofins has infringed on the patent by marketing and performing a cfDNA analysis test for transplant patients to inform about potential rejection.
"The intellectual property behind AlloSure was developed both with and for the transplant community," CareDx CEO Peter Maag said in a statement. "We are prepared to vigorously defend our intellectual property where appropriate to support continued innovation in transplantation and to protect the substantial investments we have made, as well as the leadership position we have developed over many years of effort."
CareDx said it is seeking all available remedies, including damages and injunctive relief.
"Based on our review of the suit, we believe our tests do not infringe the '652 patent ... [and] we believe CareDx's '652 patent to be invalid" Eurofins US Senior VP, Clinical Diagnostics David Morgan said in a statement. "As such Viracor intends to vigorously defend against this lawsuit, and we do not anticipate this suit to impact our commercialization efforts."
Morgan noted in the statement that Eurofins exclusively licensed the intellectual property to perform these tests from the same institution from which CareDx licensed its intellectual property. Eurofins therefore believes that CareDx is attempting to limit other laboratories from offering different cell-free DNA testing methods to help physicians confirm active organ rejection for transplant patients.
Eurofins previously acquired Transplant Genomics — which offers a test that assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection — in June to complement its existing transplant diagnostic portfolio and expand its position in the transplant testing market.
Importantly, Morgan noted in the statement that the lawsuit does not involve the TruGraf Blood Gene Expression Test. Morgan said the test will be offered through TGI when it receives final Local Coverage Determination from the Centers for Medicare & Medicaid Services through Palmetto's GBA's Molecular Diagnostic Services Program.