Innovative technology platform for cell-free DNA testing in oncology and organ transplantation uniquely positions Natera to help improve outcomes for the most vulnerable transplant patients
SAN CARLOS, Calif., Sept. 14, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, announced an expansive program to improve care for organ transplant patients with a history of cancer, using the Signatera™ test for molecular residual disease (MRD) assessment pre- and post-transplant, in combination with the Prospera™ test for transplant rejection assessment. The goal of the program is to understand how the Signatera and Prospera tests can be used to improve decision making at the complex intersection of organ transplantation and oncology, and respond to the unmet needs within these communities.
"This research program promises to be a significant advance in personalized care for transplant patients with cancer, or with a history of cancer," said Michael Volk, MD, Division Head, Gastroenterology and Hepatology, Loma Linda University Medical Center. "Not only can it help us better understand these patients’ risk as they undergo evaluation for liver and kidney transplantation, but it will inform the development of guidelines for tailored monitoring and timely treatment, an area in which data is sorely lacking."
A significant number of patients being evaluated for a transplant have a history of cancer, as patients with end-stage renal disease have a 20% higher rate of colorectal cancer than the general population,1 making it difficult for patients to receive a transplant due to the uncertain risk of recurrence. Furthermore, this is exacerbated by the fact that transplant recipients require immune-suppressing medications to avoid rejection, which can increase the risk of new or recurring cancers. There is a large unmet need for more precise, data-driven clinical practice guidelines for the assessment and management of these patients who may be denied life-saving organ transplants based on their history of cancer.
The initial phase of Natera’s program encompasses three study concepts that will be discussed in depth at the virtual TTS 2020 symposium on September 14th, 2020, in a presentation entitled, "The Interface of Solid Organ Transplant and Oncology: A New Paradigm with Cell-Free DNA" featuring Dr. Michael Volk, Division Head, Gastroenterology and Hepatology, Loma Linda University Health, and Dr. Kenar Jhaveri, Associate Chief of Kidney Diseases and Hypertension, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. The main goals are:
- Help patients with colorectal cancer to be actively listed for and receive a needed kidney transplant earlier. This will be examined in the Colorectal Neoplasm in Candidates Enlisting for Renal Transplantation study (CONCERT)
- Track hepatocellular cancer recurrence post-liver transplant for earlier, faster, and more effective intervention in the observational study of Signatera in Liver Cancer (SIGNAL)
- Understand unique organ rejection dynamics in cancer patients through the Prospera in Renal Allograft Recipients with Cancer study (PARC)
"Natera is one of the only molecular diagnostics companies with solutions in both oncology and organ transplant and thus is uniquely positioned to help the medical community improve patient outcomes," said Paul Billings, MD, PhD, Chief Medical Officer and SVP of Medical Affairs at Natera. "This important program gives us the opportunity to leverage the biological and medical synergy between transplant and oncology using highly accurate, non-invasive methods."
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The Signatera test is a custom-built circulating tumor DNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
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. Prospera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
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 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 or other 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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
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1. Chapman JR, Webster AC, Wong G. Cancer in the transplant recipient. Cold Spring Harb Perspect Med. 2013;3(7):a015677.
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