Natera Announces New Early Priority Date cfDNA Patent, Files Suit Against CareDx

SAN CARLOS, Calif., Jan. 13, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today filed suit against CareDx for infringing its U.S. Patent 10,526,658 ("the '658 patent"). The U.S. Patent Office most recently recognized Natera's innovation in cell-free DNA (cfDNA) when it awarded the '658 patent on January 7^th, 2020. The '658 patent covers cfDNA-based diagnostic methods, including those for transplant. Natera now has over 200 patents issued and pending, including more than twenty in the field of transplant.

"Over the past 15 years, our team has developed several novel molecular and statistical methods that have enabled differentiated cfDNA test performance and contributed to our strong leadership position. We've now performed over 2 million cfDNA tests commercially and published the results of over 1 million cfDNA tests in top peer-reviewed journals," said Steve Chapman, Natera's CEO. "We intend to protect our technology and continue our relentless pursuit of innovation to improve patient care."

In recent studies separately evaluating Prospera™ and Allosure^®, Prospera had an 89% sensitivity for rejection, compared with a 59% sensitivity for Allosure.¹ Natera's NPV was 95%, compared with 84% for Allosure, in a similar incidence cohort.^1,2 Additionally, Prospera detected 10/10 T Cell-Mediated Rejection samples while Allosure could only identify 3/11.²  

Recently, Medicare issued a final positive coverage decision for Prospera after receiving an overwhelming majority of positive comments during the public comment period. In addition, Medicare independently ranked Prospera's strength of evidence higher than that of Allosure.

"Natera intends to defend its intellectual property vigorously. CareDx will be held accountable for its blatant lack of respect for Natera's innovation and clear infringement of its intellectual property," said Charles K. Verhoeven of Quinn Emanuel Uruqhart & Sullivan LLP, counsel for Natera.

About the Prospera dd-cfDNA Organ Transplant Test
The Prospera test leverages Natera's core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy.

The test was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.

About Natera
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 in 2019. For more information, visit www.natera.com, or follow Natera on LinkedIn.

Forward-Looking Statements
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.

Natera Contacts
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kevin Knight, 206-451-4823, [email protected]

References:

1. Sigdel TK, Archila FA, Constantin T, et al. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2019;8(1):19.
2. Bloom RD, Bromberg JS, Poggio ED, et al. Cell-free DNA and active rejection in kidney allografts. J Am Soc Nephrol. 2017;28(7):2221-2232.

SOURCE Natera, Inc.

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