Coverage Expanded Beyond Initial Draft Local Coverage Decision
SAN CARLOS, Calif., Dec. 19, 2019 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that Medicare has finalized its local coverage determination (LCD) to provide insurance coverage for the Prospera donor-derived cell-free DNA (dd-cfDNA) test, for all kidney transplant recipients, including those with multiple kidney transplants, an expansion in coverage from the initial draft. Nearly all newly transplanted patients are eligible for Medicare coverage.
The Prospera test assesses the risk of active renal allograft rejection with greater precision than other biomarkers or other dd-cfDNA tests on the market. Prospera is the industry's first dd-cfDNA test clinically validated to identify both T-cell mediated rejection and antibody mediated rejection.1,2
"In the summer of 2018, we announced our timeline to achieve a final coverage decision by the end of 2019. I am proud of the Natera team for achieving every major milestone on time, enabling the imminent commercialization of Prospera," said Steve Chapman, Natera's CEO. "The expansion in coverage allows us to help an important new set of patients."
More than 190,000 Americans are living with a kidney transplant and roughly 20,000 new kidney transplant surgeries are performed each year.3,4 It is estimated that 20-30 percent of kidney transplants fail within five years, and approximately 45 percent fail within 10 years.5,6
"Medicare coverage for Prospera is significant for Natera and for patient care," said Paul Billings, M.D., Ph.D., Natera's Chief Medical Officer. "There are more than 113,000 men, women and children that are on organ transplant waiting lists.4 Sustaining every organ is critical to saving lives."
Traditional tools for diagnosing organ transplant rejection are either invasive biopsies, or inaccurate serum creatinine tests. Prospera was created to help physicians improve graft survival by optimizing immunosuppression levels and avoiding unnecessary biopsies.
Earlier this year, Natera announced the ProActive Study, the industry's largest prospective registry study for kidney transplant recipients using cell-free DNA assessment. The study will enroll 3,000 kidney transplant patients from the time of surgery, and will measure changes in biopsy usage and clinical outcomes based on physician-directed use of the Prospera test. The study protocol calls for most patients to be followed for three years, while a subset of high-risk patients will be studied up to five years after transplantation. For more information, 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.
The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. In repeatability and reproducibility studies, it showed superior precision with a coefficient of variation up to five times better than that of a competitive dd-cfDNA assay (1.85% vs. 9.2% within run; 1.99% vs. 4.5% across runs).7,8 In clinical validation, Natera reported higher sensitivity (89% vs. 59%) and higher area under the curve (0.87 vs. 0.74) than the competing dd-cfDNA assay.1,2 Prospera is the first assay with high sensitivity to both T-cell mediated and antibody mediated rejection,1,2 and it is the first to detect subclinical rejection,1 which occurs in 20-25 percent of patients in the first two years post transplant,9 and is considered a major driver of graft failure.
The test was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve 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 physicians who care for pregnant women, 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 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 to obtain favorable coverage and reimbursement determinations from third-party 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
Media: Kevin Knight, 206-451-4823, email@example.com
- 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.
- 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 Jan. 16, 2019.
- Stegall MD, Gaston RS, Cosio FG, Matas A. Through a glass darkly: seeking clarity in preventing late kidney transplant failure. J Am Soc Nephrol. 2015;26(1):20-9.
- Lamb KE, Lodhi S, Meier-Kriesche HU. Long-term renal allograft survival in the United States: a critical reappraisal. Am J Transplant. 2011;11(3):450-62.
- Altuğ Y, Liang N, Ram R, et al. Analytical validation of a single-nucleotide polymorphism-based donor-derived cell-free DNA assay for detecting rejection in kidney transplant patients. Transplantation. 2019.
- Grskovic M, Hiller DJ, Eubank LA, et al. Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016;18(6):890-902.
- 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;5(6)1354-1360.
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SOURCE Natera, Inc.