CareDx Files Lawsuit Against Eurofins Viracor

CareDx (NASDAQ:CDNA) has officially filed a patent lawsuit infringement suit against Eurofins Viracor in the US District Court for Delaware, the company said on Thursday (September 26).

In a press release, the California-based precision medicine company claims that Eurofins has violated CareDx’s US Patent 8,703,652, licensed solely to CareDx from Stanford University.

The company says that non-invasive monitoring of organ transplant rejection through cell-free DNA analysis falls under the patent, which is the main structure of CareDx’s AlloSure platform.

In simple terms, AlloSure is a non-invasive blood test that evaluates the health of a patient’s donor kidney after transplant, and measures donor-derived cell-free DNA (dd-cfDNA) in the blood. If there happens to be an injury after a transplant, dd-cfDNA gets released into the patient’s blood, which can potentially be a rejection of the transplant.

CareDx said it has been working for roughly two decades on research and development for transplantation, adding that it landed its exclusive license for AlloSure when it acquired ImmunMetrix in 2014.

“The intellectual property behind AlloSure was developed both with and for the transplant community,” Peter Maag, CEO of CareDx, said in the press release.

CareDx’s patent infringement suit against Eurofins isn’t the only one the company has filed this year.

In March, CareDx filed a patent infringement suit against Natera (NASDAQ:NTRA), claiming Natera infringed the patent with a test that analyzes cell-free DNA from a transplant patient to advise of the transplant’s rejection.

Natera responded to the patent lawsuit in a separate release, stating that its own test doesn’t require genotyping. Natera also said that its organ transplant rejection test achieved stronger analytical and clinical test performance than CareDx’s.

CareDx then accused Natera of false advertising in April in a second lawsuit against the company. CareDx claimed that Natera had initiated false advertising campaigns to convince healthcare professionals and investors that its device was superior to CareDx’s AlloSure.

To date, there has been no resolution between CareDx and Natera.

Thursday’s announcement comes just days after CareDx launched AlloSeq Tx, a type of sequencing technology for human leukocyte antigen (HLA) matching. HLA matching is a process that matches patients and donors for bone marrow transplants.

“AlloSeq Tx enables a view into the transplantome that is not available with current methods, including additional targets that HLA experts are interested in studying,” David Sayer, vice president of global transplant laboratory solutions at CareDx, said in a separate press release.

Over Thursday’s trading session, shares of CareDx dipped 4.36 percent to close at US$21.71. Year-to-date, the company’s share price has had somewhat of a bumpy ride, having reached a 2019 high of US$40.08 in July. Overall, CareDx is down 5.43 percent since the start of the year.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.