News Release

Natera Announces Agreement with One Lambda to Co-Distribute Its Kidney Transplant Rejection Test
Agreement Enhances Commercial Presence in Organ Transplant Centers

SAN CARLOS, Calif., Feb. 1, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of cell-free DNA, today announced a partnership with Thermo Fisher Scientific's One Lambda brand, a global leader in human leukocyte antigen (HLA) typing and antibody monitoring assays for transplantation, to co-distribute Natera's kidney transplant rejection test in the United States in collaboration with the company's direct sales team.

Steve Chapman, CEO, Natera

"We are excited to partner with One Lambda, a pioneer in transplant diagnostics," said Steve Chapman, CEO, Natera. "This partnership will help accelerate our entry into this new market by leveraging the commercial infrastructure of a highly respected and well-established leader in the field, along with our direct sales team."

"Natera's donor-derived cell-free DNA test complements our existing transplant offerings and enables us to provide a more advanced portfolio for monitoring kidney rejection," said Parisa Khosropour, President, Transplant Diagnostics, Thermo Fisher Scientific. "We look forward to offering our customers a test that improves upon currently available options and provides unique performance advantages in detecting T-cell mediated rejection and subclinical acute rejection, both of which may have a more positive impact on patient outcomes."

About Natera's dd-cfDNA Organ Transplant Assay
Natera's organ transplant rejection assay is designed to detect active allograft rejection in patients who have undergone kidney transplantation. The assay works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood, which can spike relative to normal cfDNA when the transplanted organ is injured due to immune rejection. The assay leverages Natera's core single nucleotide polymorphism (SNP)-based massively multiplexed PCR (mmPCR) technology to accurately measure dd-cfDNA levels without the need for donor genotyping, and it has been clinically validated with test performance independent of donor type, rejection type, and clinical presentation.

In a recent study published in the Journal of Clinical Medicine, Natera's assay detected acute rejection (AR) with 89% sensitivity and 0.87 area under the curve (AUC).1 This test performance compares favorably to the current standard of care, which is based on serial measurements of serum creatinine; and it compares favorably against competition, which in a 2017 study reported 59% sensitivity and 0.74 AUC.2 The recent study also had two novel, clinically significant findings relative to previously published studies of dd-cfDNA. The Natera dd-cfDNA assay was able to accurately detect TCMR (T-cell mediated rejection), a common and treatable form of active rejection, and subclinical acute rejection.1 No other dd-cfDNA assay has been shown to detect TCMR or validated to detect subclinical AR, which occurs in 20-25% of patients in the first two years post-transplant,3 and which is considered a major driver of graft failure.

About One Lambda
One Lambda, a Thermo Fisher Scientific brand, is the global leader in HLA and antibody monitoring assays for transplantation. Known for its commitment to quality, service, and innovation, the company develops and distributes several lines of HLA typing and antibody monitoring tests utilizing serological, molecular, flow, solid phase & NGS technologies. In addition, One Lambda also provides laboratory instrumentation and computer software that are used to simplify and automate testing procedures and final test evaluations. For more information, please visit www.onelambda.com.

About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the management of diseases worldwide. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.

Natera 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. 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.

Contacts for Natera
Investor Relations: Mike Brophy, CFO, Natera, 650-249-9090
Media: Andrea Sampson, Sullivan & Sampson, 714-374-6174, asampson@sullivanpr.com

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. doi: 10.1681/ASN.2016091034.
  3. Choi BS, Shin MJ, Shin SJ, et al. Clinical significance of an early protocol biopsy in living-donor renal transplantation: ten-year experience at a single center. Am J Transplant. 2005;6:1354-1360.

 

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