SAN CARLOS, Calif., Jan. 27, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA testing, filed suit today against ArcherDX for infringement of Natera’s U.S. Patent No. 10,538,814 (the "’814 patent"). The complaint was filed in the U.S. District Court of Delaware.
The ‘814 patent is titled "Methods for Simultaneous Amplification of Target Loci" and was issued by the United States Patent and Trademark Office ("USPTO") on January 21, 2020. The ‘814 patent claims methods for using multiplex polymerase chain reaction ("multiplex PCR") technology to simultaneously amplify multiple nucleic acid regions of interest in a single reaction before using high-throughput sequencing to characterize the nucleic acids. The ‘814 patent is one of more than 200 patents issued or pending in Natera’s global intellectual property portfolio, including more than 60 in the field of oncology.
Natera’s complaint alleges that ArcherDX’s sale and use of certain cell-free DNA-based oncology products infringes on the ‘814 patent. ArcherDX has introduced oncology products using multiplex PCR technology, including a tool for personalized cancer monitoring. Natera has the exclusive rights to perform and license personalized monitoring and MRD testing in oncology using its patented multiplex PCR technology. Natera is seeking injunctive relief and monetary damages.
"Natera will enforce its intellectual property rights and will stop unlicensed use of its patented technology in the field of minimal residual disease and personalized cancer monitoring," said Gary Frischling from the law firm Milbank LLP, Natera’s counsel in the matter.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to obstetricians, oncologists, transplant nephrologists, academic researchers, drug developers, and genetic laboratories through its cloud-based software platform. Natera’s flagship cancer assay, Signatera, was designated by the FDA as a Breakthrough Device and has received a draft coverage determination from Medicare for use in Stage II and III colorectal cancer. For more information, visit www.natera.com, or follow Natera on LinkedIn.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers, our ability to obtain favorable coverage and reimbursement determinations from third-party payers, and the scope of protection we establish and maintain for, and developments or disputes concerning, our intellectual property or other proprietary rights. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kevin Knight, 206-451-4823, firstname.lastname@example.org
SOURCE Natera, Inc.