SAN CARLOS, Calif., /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the assignment of a unique Z-code for the company's kidney transplant rejection assay, representing a key reimbursement milestone in preparation for the commercialization of its CLIA-certified lab developed test in 2019.
"We are pleased with this progress along our reimbursement pathway," said Steve Chapman, Natera's Chief Operating Officer. "Obtaining this unique Z-code is an essential part of our CPT coding strategy, and it also puts us on similar footing with other companies in this space."
Natera recently completed analytical and clinical validation of its donor-derived cell-free DNA assay, leveraging its proprietary massively-multiplexed PCR technology. In a blinded study, Natera's assay successfully distinguished between active rejection and non-rejection, with high sensitivity and specificity.1 The company is in the process of submitting its Medicare dossier for LCD (local coverage determination) consideration.
"There is a significant unmet need for more accurate, non-invasive tools to monitor transplant rejection," said Dr. Paul Billings, Natera's Chief Medical Officer and Senior Vice President, Medical Affairs. "Natera's assay may help physicians detect rejection events earlier, avoid unnecessary biopsies, and more safely optimize immunosuppression levels."
There are more than 190,000 people living with a kidney transplant in the United States 2 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
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease 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, our efforts to translate our technology and expertise in prenatal testing into oncology and organ transplant rejection applications, our estimates of the total addressable markets for our current and potential 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, or our ability and expectations regarding obtaining, maintaining and expanding reimbursement for our tests. 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
Mike Brophy, CFO, Natera, 650-249-9090
Barbara Sullivan, Sullivan & Associates, 714-374–6174, firstname.lastname@example.org
- Natera data on file. The Transplant Society Annual Meeting in Madrid, July 2018.
- Kidney 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.
- Organ 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.
- Bromberg, et al. Biological variation of donor-derived cell-free DNA in renal transplant recipients: clinical implications. J Appl Lab Med. 2017; 2:309-321.
- Natera data on file. June 2018.
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