Dive Brief:

• Genetic testing company Natera said Monday it filed a lawsuit alleging next generation sequencing assay maker ArcherDX’s cell-free DNA-based oncology products infringe a Natera patent.

• In a statement, San Carlos, California-based Natera claimed it has the exclusive rights to perform personalized monitoring and minimal residual disease (MRD) testing in oncological indications using its multiplex polymerase chain reaction (PCR) technology.

• The lawsuit comes shortly after Natera took legal action against molecular diagnostics company CareDx over another patent.

Dive Insight:

ArcherDX and Natera are both working in cancer care through the use of technologies such as PCR. Last year, ArcherDX raised $60 million to fund work to apply its technology to the assessment of MRD, thereby enabling physicians to detect the recurrence or progression of disease earlier and intervene accordingly.

Natera asserts ArcherDX’s work infringes on its patent. The patent, which was issued last week, covers "methods for simultaneously amplifying multiple nucleic acid regions of interest in one reaction volume."

Natera believes the patent gives it “the exclusive rights to perform and license personalized monitoring and MRD testing in oncology using its patented multiplex PCR technology," and filed a lawsuit against ArcherDX seeking injunctive relief and monetary damages. Natera filed the complaint in the District Court of Delaware.

The lawsuit is part of a broader, ongoing dispute over who has the right to use certain technologies that enable noninvasive testing. Natera is involved in some of the legal cases, both as a plaintiff and defendant. 

Last year, CareDx filed a patent infringement lawsuit against Natera. The lawsuit accused Natera of infringing a patent covering the use of cell-free DNA analysis in the noninvasive monitoring of organ transplant rejection. CareDx went on to accuse Natera of making false and misleading advertising claims. Both sides claimed victory when a court considered whether to dismiss the advertising case.  

Earlier this year, Natera hit back against CareDx, filing a lawsuit accusing its rival of infringing on one of its patents. That suit is focused on a patent covering cell-free DNA analysis in contexts including transplant patients. 

The legal cases have played out against a backdrop of rising expectations for Natera. Over the past year, Natera’s share price has risen more than 150% as the company has achieved double-digit sales growth.