DEDUCE study demonstrates AUC of 0.86 in overall cohort, including more than 700 prospective samples
This multi-site clinical validation, named the DEDUCE study, was conducted in partnership with the
"There is a critical unmet need for an accurate and less invasive approach for rejection surveillance after heart transplant," said
The study also included an analysis on the use of dd-cfDNA concentration alone to identify rejection. dd-cfDNA concentration demonstrated an AUC of 0.88 overall, and 0.89 in the prospective cohort, highlighting the potential (upon additional studies and evaluation) to further improve the performance of the Prospera Heart test by evaluating both dd-cfDNA concentration and donor fraction.
The Prospera Heart test was launched in late 2021 and will continue to be evaluated in a variety of additional studies, including the
About the Prospera 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. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 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 our efforts to develop and commercialize new 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 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
Contacts
Investor Relations: Mike Brophy, CFO,
Media: Kate Stabrawa, Communications,
References
- Kim PJ, Olymbios M, Siu A, et al. A novel donor-derived cell-free DNA assay for the detection of acute rejection in heart transplantation. J. Heart Lung Transplant.
April 2022 . DOI: https://doi.org/10.1016/j.healun.2022.04.002. - Web of
Sciences Group impact factor as reported by scijournal.org. - Natera data on file for performance breakdown in prospective cohort.
View original content to download multimedia:https://www.prnewswire.com/news-releases/multi-site-clinical-validation-of-prospera-heart-test-demonstrates-outstanding-performance-in-assessing-heart-transplant-rejection-301524512.html
SOURCE
DEDUCE study demonstrates AUC of 0.86 in overall cohort, including more than 700 prospective samples
This multi-site clinical validation, named the DEDUCE study, was conducted in partnership with the
"There is a critical unmet need for an accurate and less invasive approach for rejection surveillance after heart transplant," said
The study also included an analysis on the use of dd-cfDNA concentration alone to identify rejection. dd-cfDNA concentration demonstrated an AUC of 0.88 overall, and 0.89 in the prospective cohort, highlighting the potential (upon additional studies and evaluation) to further improve the performance of the Prospera Heart test by evaluating both dd-cfDNA concentration and donor fraction.
The Prospera Heart test was launched in late 2021 and will continue to be evaluated in a variety of additional studies, including the
About the Prospera 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. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 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 our efforts to develop and commercialize new 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 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
Contacts
Investor Relations: Mike Brophy, CFO,
Media: Kate Stabrawa, Communications,
References
- Kim PJ, Olymbios M, Siu A, et al. A novel donor-derived cell-free DNA assay for the detection of acute rejection in heart transplantation. J. Heart Lung Transplant.
April 2022 . DOI: https://doi.org/10.1016/j.healun.2022.04.002. - Web of
Sciences Group impact factor as reported by scijournal.org. - Natera data on file for performance breakdown in prospective cohort.
View original content to download multimedia:https://www.prnewswire.com/news-releases/multi-site-clinical-validation-of-prospera-heart-test-demonstrates-outstanding-performance-in-assessing-heart-transplant-rejection-301524512.html
SOURCE
