Data to be Presented at The Transplantation Society International Congress in Madrid on July 3, 2018
SAN CARLOS, Calif., June 21, 2018 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA analysis, announces a powerful new kidney transplant rejection biomarker and study results in collaboration with the University of California, San Francisco, a recognized leader in transplantation care. The data demonstrates superior performance of its massively-multiplexed PCR (mmPCR) technology for detecting acute rejection in kidney transplant patients.
In a blinded, retrospective study, Natera leveraged its validated SNP (Single Nucleotide Polymorphism) technology to measure donor-derived cell-free DNA levels (dd-cfDNA) in 300 plasma samples from 193 unique kidney transplant patients, including 52 patients experiencing acute rejection. The assay was designed based on years of experience in differentiating maternal DNA from fetal DNA in reproductive health. This is the largest patient cohort to date, comparing dd-cfDNA levels to organ biopsies, the current gold standard for organ status assessment.
Natera’s dd-cfDNA assay demonstrated 92% sensitivity in detecting acute rejection, identifying 48 out of 52 affected cases based on a cutoff of 1% dd-cfDNA. This sensitivity compares favorably against competition, which reported only 59% sensitivity in a 2017 study.1 This performance data suggests the potential of Natera’s assay for use in both rule-in and rule-out applications.
There is a significant unmet need for more accurate non-invasive tools to monitor for allograft rejection. Natera’s assay could help physicians detect rejection events earlier, avoid unnecessary biopsies, and safely optimize immunosuppression levels, potentially lowering the overall costs associated with transplant care. With over 190,000 people living with a kidney transplant in the United States2 and roughly 20,000 new kidney transplant surgeries performed each year,3 the kidney transplant market opportunity has been estimated at over $2 billion.4,5 Similar dd-cfDNA tests are reimbursed at approximately $2,800. Natera expects to launch a CLIA-certified laboratory developed clinical test in 2019.
"We are very pleased with the results of this study," noted Dr. Paul Billings, Natera’s Chief Medical Officer and Senior Vice President, Medical Affairs. "Natera’s unique mmPCR technology has excellent clinical utility potential for patients living with renal and other organ transplants. I look forward to working with the medical community to introduce this rapidly into clinical practice."
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. 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 and organ transplantation including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.
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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
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1Bloom, et al. Cell-free DNA and active rejection in kidney allografts. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232. doi: 10.1681/ASN.2016091034. Epub 2017 Mar 9
2Kidney Disease Statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease. Published Dec. 1, 2016.
3Organ Donation Statistics. U.S. Department of Health and Human Services. U.S. Government Information on Organ Donation and Transplantation. https://www.organdonor.gov/statistics-stories/statistics.html. Published March 31, 2016.
4Bromberg, et al. Biological variation of donor-derived cell-free DNA in renal transplant recipients: clinical implications. J Appl Lab Med. 2017;2:309-321.
5Natera data on file. June 2018.
SOURCE Natera, Inc.