SAN CARLOS, Calif., May 11, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that Noridian, a Medicare Administrative Contractor (MAC), has issued positive coverage for the Prospera donor-derived cell-free DNA (dd-cfDNA) test. Noridian also announced it is developing a generic policy for dd-cfDNA testing that will include multiple commercially available tests under one consistent policy – Prospera's coverage will be under the new policy in the future along with others.
Last week, Natera announced the early success of the ProActive study, which has already activated 18 of the top transplant centers and enrolled more than 145 patients. In addition, Natera announced strong interest in its early access program, receiving tests from 45% of the top 50, and 37% of the top 100 transplant centers by volume.
"We are very pleased with the overwhelmingly positive comments received from the transplant community during the Medicare open comment period, and to have received positive coverage for the Prospera test," said Phil Gauthier, M.D., a transplant nephrologist and Natera's medical director of transplant.
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 US, 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 coverage and reimbursement determinations from third-party payers, 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 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
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [email protected]
SOURCE Natera, Inc.