These are the second and third peer-reviewed publications evaluating Natera's technology for use in heart transplantation.
'We are encouraged by the results of these two prospective studies,' said
The Prospera Heart test was launched in 2021 and received Medicare coverage following the 2022 publication of a multi-site clinical validation study, the DEDUCE study, in the
The DTRT-2 (DNA-Based Transplant Rejection Test) study, published recently in Pediatric Transplantation, was sponsored by the
'DTRT-2 is a landmark study that further demonstrates that the Prospera Heart test is a highly reliable, non-invasive tool for detecting heart transplant rejection in adult patients, and now solidifies that outstanding performance for pediatric patients as well,' said Shriprasad R. Deshpande, MBBS, MS, director of the Advanced Cardiac on Therapies and Heart Transplant Program,
The Trifecta-Heart study had its initial publication last week in Transplantation and has an upcoming oral presentation at the 2024
Roughly 4,100 heart transplants are performed each year in the
These latest data come just before the 2024 ISHLT Annual Meeting, where Natera will deliver one oral presentation and six poster presentations related to its
About the Prospera test
The ProsperaTM 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.
About Natera
NateraTM is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
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 whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, or our expectations of the benefits of our 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
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