Medicare issues new coverage guidance for dd-cfDNA testing, enabling coverage beyond kidney transplants
AUSTIN, Texas, April 22, 2021 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and a global leader in cell-free DNA testing, receives pathway to future coverage for the Prospera donor-derived, cell-free DNA (dd-cfDNA) test to determine transplant rejection status in multiple organs.
Today, the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MoLDX) published a future effective local coverage determination (LCD) that identifies and establishes this pathway to coverage in a broad range of solid organ transplants. This new LCD adds to existing CMS coverage for the Prospera test in kidney transplant rejection assessment. The LCD is posted here on the CMS website.
Natera has performed over 3 million cfDNA tests and has published more than 50 papers studying over 1 million patients.
"We’ve built a very powerful technology platform that’s been proven across women’s health, oncology and organ health indications," said Steve Chapman, CEO of Natera. "Helping physicians non-invasively detect rejection of transplanted organs may improve the quality of life for the hundreds of thousands of patients living with organ transplants."
"We are delighted that CMS, through this LCD, recognizes the important role of dd-cfDNA transplant rejection assessment testing for other solid organ transplants beyond kidney," said Paul Billings, chief medical officer at Natera. "Receiving this LCD highlights the growing recognition for dd-cfDNA monitoring as a critical tool in the treatment of organ transplant patients."
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). The laboratory is regulated under CLIA as qualified to perform high-complexity testing.
Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women’s health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. 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 tests, or regarding the benefits of our tests and product offerings to patients, providers and payers, or 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., 510-826-2350
Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., firstname.lastname@example.org
SOURCE Natera, Inc.