Traditionally, donor-derived cell-free DNA (dd-cfDNA) tests have reported rejection risk based only on the fraction of dd-cfDNA in the blood vs. the total cfDNA (dd-cfDNA %). This fraction can be confounded by fluctuations in the amount of background total cfDNA (the denominator), which are sometimes caused by factors unrelated to the health of the transplant, including infection, surgery, or chemotherapy.
Over the last two decades, Natera has pioneered cfDNA testing across women s health, oncology, and transplant medicine, said Michael Olymbios, M.D., Medical Director, Heart Transplant. Our extensive experience with cfDNA and Natera s culture of continuous innovation drove us to further refine
A study performed at the
Specificity increased from 76.1% to 84.2%, reducing false positive results by 37.5%
Increased negative predictive value (NPV) from 97.4% to 98.6%
The study was presented at
The initial findings from our study indicate that DQS complements donor fraction and provides a clearer picture of rejection risk for the patient, compared to donor fraction alone, said
A similar two-threshold dd-cfDNA test for assessing the risk of kidney transplant rejection,
About Prospera
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.
About Natera
Natera is a global leader in cell-free DNA and genetic 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 200 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.
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Email: investor@natera.com
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