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
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
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
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
View original content to download multimedia:http://www.prnewswire.com/news-releases/prospera-receives-positive-medicare-coverage-301056895.html