SAN CARLOS, Calif., May 4, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced the achievement of key recruitment milestones in the ProActive registry study and success in the Prospera early access program.
The ProActive study will follow 3,000 kidney transplant patients over a three to five year period to examine the utility of the Prospera donor-derived cell-free DNA (dd-cfDNA) transplant assessment test to accurately identify organ rejection. The study is outpacing Natera’s enrollment expectations with 18 top transplant centers already activated, more coming online in the near future, and 145 patients currently enrolled.
"The ProActive trial is a large, prospective registry study designed to provide valuable insights on clinical biomarkers, biopsy usage and clinical outcomes. Participation by top transplant centers in the U.S. is leading to increasing enrollment and accumulation of important data. It is notable this is happening even during these difficult times for our transplant patients and centers during the COVID-19 pandemic, demonstrating the fortitude and commitment of transplant professionals to the future of the field. I am confident this trial will improve the care of our patients and look forward to the results," said Jonathan Bromberg, M.D., Professor of Surgery and Microbiology and Immunology, Vice Chair for Research at the University of Maryland School of Medicine, and Principal Investigator of the ProActive study.
In the Prospera early access program, Natera has received tests from 45% of the top 50 and 37% of the top 100 transplant centers by volume. "The strong interest in Prospera and the significant number of top centers ordering tests during the early access program reflects a desire for more accurate, non-invasive testing methods, which Prospera fulfills through its ability to identify rejection with higher accuracy than first generation dd-cfDNA tests and current standards of care,"1,2 said Paul Billings, M.D., Ph.D., Chief Medical Officer and SVP of Medical Affairs at Natera.
To learn more about the ProActive study, click here.
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. Prospera has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. The test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA has generally not enforced the premarket review and other FDA legal requirements for laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
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 inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. 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 the near- and long-term impact of the COVID-19 pandemic on our business and results of operations, our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our ability to complete clinical studies or whether the results of such 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 investor.natera.com and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
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- 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.
- 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.