Some of the most anticipated Prospera study data to be shared include:<\/p>\n
- \n
- Even when biopsy results are negative for rejection, elevated Prospera dd-cfDNA levels were strongly predictive of future adverse outcomes, including eGFR decline, DSA positivity, and graft loss. New data from the PEDAL study <\/b>in 346 kidney transplant patients with non-rejection biopsy results showed that patients with positive Prospera results, which occurred in 18.2% of these cases, had significantly higher rates of adverse outcomes, including >6X the rate of graft loss. The data suggest that positive dd-cfDNA results indicate an increased risk for adverse outcomes, even when biopsy does not show rejection.\n<\/li>\n
- Patients with persistently low Prospera dd-cfDNA levels had reliable and significantly lower adverse outcome rates, which may enable confident decisions to lower immunosuppression. In a new analysis of 989 kidney transplant recipients from the ProActive study<\/b>, when a patient\u2019s Prospera dd-cfDNA donor-fraction remained <0.5%, patients had significantly lower rates of adverse outcomes, including ~12X reduced odds of future rejection and ~5.5X reduced odds of future graft loss. These results demonstrate that low Prospera dd-cfDNA was prognostic of durable graft stability and reiterate the importance of ongoing and regular monitoring.<\/li>\n<\/ul>\n
“Natera is leading the next phase of studies and evidence generation for dd-cfDNA,\u201d said Sangeeta Bhorade, M.D., chief medical officer, organ health, Natera. \u201cIt is well established that Prospera identifies rejection, and our new data, like that from PEDAL and ProActive, are evaluating its impact on real clinical decision making for transplant patients. These data reinforce the importance of using the Prospera test regularly as a non-invasive way to monitor patients and help guide care decisions that may support longer graft life and better outcomes.\u201d<\/p>\n
Full list of Natera presentations at ATC<\/span><\/b>:<\/b><\/p>\n
June 20, 5:45 PM ET | Abstract #A003<\/b>
Presenter: Catherine Spellicy, Ph.D.
The Edge of Detection: Defining Critical Thresholds for the Prospera Donor-Derived Cell-Free DNA Transplant Rejection Screen<\/i><\/p>\nJune 20, 5:45 PM ET | Abstract #A363 (ProActive)<\/b>
Presenter: Jonathan Bromberg, M.D., Ph.D.
Consistently Low Donor-Derived Cell-Free DNA Identifies Allograft Stability in Kidney Transplant Recipients<\/i><\/p>\nJune 20, 5:45 PM ET | Abstract #A380<\/b>
Presenter: Mita Banik, Ph.D.
A Novel Hierarchical Machine Learning Framework for Predicting Kidney Transplant Rejection Subtype<\/i><\/p>\nJune 21, 8:30 AM ET | Abstract #254<\/b>
Presenter: Ginger DeLario, Ph.D., M.T. (ASCP), CPTC
Are Transplant APPs Ready for Certification? National Findings from the American Board for Transplant Certification (ABTC)<\/i><\/p>\nJune 21, 2:45 PM ET | Abstract #B258<\/b>
Presenter: Quinn Stein, M.S., CGC
Busting the Age Myth: Clinically Significant Genetic Findings in Living Donor Candidates Are Not Limited to the Young<\/i><\/p>\nJune 21, 2:45 PM ET | Abstract #B261<\/b>
Presenter: Keysha M. L\u00f3pez Vega, M.D.
Genetic Testing in Kidney Transplant Candidates and Recipients: Three Cases of Adenine Phosphoribosyltransferase (APRT) Deficiency Identified in Puerto Rico<\/i><\/p>\nJune 21, 2:45 PM ET | Abstract #B266<\/b>
Presenter: Maggie Westemeyer, M.S., CGC
Positive Genetic Test Results in Living Kidney Donor Candidates: Common and Broadly Distributed Across Genes<\/i><\/p>\nJune 21, 5:00 PM ET | Abstract #490 (Oral Presentation)<\/b>
Presenter: Quinn Stein, M.S., CGC
Carrier Findings Are Common and Clinically Relevant in Living Kidney Donor Candidates<\/i><\/p>\nJune 22, 8:15 AM ET | Abstract #554 (Trifecta Heart, Oral Presentation)<\/b>
Presenter: Katelynn Madill-Thomsen, Ph.D.
In heart transplants, DSA-negative and DSA-positive antibody-mediated rejection have similar molecular features, timing, dd-cfDNA and leukocyte composition<\/i><\/p>\nJune 22, 2:45 PM ET | Abstract #C090<\/b>
Presenter: Gregory Lewis, M.D.
Biopsy to Biomarker: Evolution of Post-Heart Transplant Surveillance Practices from the ProTECT Study<\/i><\/p>\nJune 22, 2:45 PM ET | Abstract #C093 (Trifecta Heart)<\/b>
Presenter: Martina Mackova, Ph.D.
Comparing Histological Acute Cellular Rejection Grade 1R with Molecular Microscope\u00ae Diagnostic System Classifiers and Donor-Derived Cell-Free DNA (dd-cfDNA) Levels<\/i><\/p>\nJune 22, 2:45 PM ET | Abstract #C100 (Trifecta Heart)<\/b>
Presenter: Patrick Gauthier, Ph.D.
Incremental Increase in Donor-Derived Cell-Free DNA (dd-cfDNA) and Risk of Molecular Rejection in Heart Transplant (HT) Recipients<\/i><\/p>\nJune 22, 2:45 PM ET | Abstract #C157<\/b>
Presenter: Meg Hager, M.S., MPH, CGC
Conversations That Lead to Action: Genetic Counselors and Living Kidney Donors<\/i><\/p>\nJune 22, 2:45 PM ET | Abstract #C358<\/b>
Presenter: Shelley Hall, M.D.
Donor-Derived Cell-Free DNA (dd-cfDNA) and Clinical Outcomes in Heart Transplant (HT) Patients (Pts) with Antibody Mediated Rejection (AMR): ProTECT Study<\/i><\/p>\nJune 23, 2:30 PM ET | Abstract #D083 (ProActive)<\/b>
Presenter: Matthew Cooper, M.D.
Association Between dd-cfDNA and Future Development of DSA or Rejection in Kidney Transplant Recipients with TCMR<\/i><\/p>\nJune 23, 2:30 PM ET | Abstract #D120 (ProActive)<\/b>
Presenter: Sanjeev Akkina, M.D.
Dd-cfDNA in Kidney Transplant Recipients (KTRs) with Cancer<\/i><\/p>\nJune 23, 2:30 PM ET | Abstract #D266<\/b>
Presenter: Justin Rosenheck, D.O.
Torque Teno Virus (TTV) Viral Load (VL) Correlates with Tacrolimus (TAC) Levels but Not Lymphocyte Subsets or Immunoglobulins After Lung Transplantation (LT)<\/i><\/p>\nJune 23, 2:30 PM ET | Abstract # D285<\/b>
Presenter: Abraham Matar, M.D.
Donor-Derived Cell-Free DNA for Detection of Rejection After Pancreas Transplantation<\/i><\/p>\nJune 24, 9:30 AM ET | Abstract #1314 (Trifecta Heart, Oral Presentation)<\/b>
Presenter: Martina Mackova, Ph.D.
In Heart Transplants Current Standard-of-Care Management of TCMR and ABMR is Often Associated with Persistence of Molecular Rejection and Elevated dd-cfDNA<\/i><\/p>\nJune 24, 9:30 AM ET | Abstract #1316 (Trifecta Kidney, Oral Presentation)<\/b>
Presenter: Philip Halloran, M.D.
Current Standard-of-Care Management of TCMR and ABMR in Kidney Transplant Patients is Associated with Persistence of Molecular Rejection and Elevated dd-cfDNA<\/i><\/p>\nJune 24, 9:30 AM ET | Abstract #1331 (Oral Presentation)<\/b>
Presenter: Gaurav Gupta, M.D.
Donor-Derived Cell-Free DNA in Pancreas-Kidney, Heart-Kidney, and Liver-Kidney Multiorgan Transplant Recipients (MOTR)<\/i><\/p>\nJune 24, 9:30 AM ET | Abstract #1333 (PEDAL, Oral Presentation)<\/b>
Presenter: Yasir Qazi, M.D., Ph.D., FACS
Post-Rejection Donor-Derived Cell-Free DNA and Serum Creatinine Trends in Kidney Transplant Recipients<\/i><\/p>\nJune 24, 9:30 AM ET | Abstract #1335 (PEDAL, Oral Presentation)<\/b>
Presenter: Suphamai Bunnapradist, M.D.
Donor-Derived Cell-Free DNA as a Prognostic Biomarker in Biopsy-Negative Kidney-Transplant Recipients<\/i><\/p>\nAbout Natera<\/b><\/p>\n
Natera\u2122 is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women\u2019s 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\u2019s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com<\/a>.<\/p>\n
Forward-Looking Statements<\/b><\/p>\n
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera\u2019s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera\u2019s 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, our expectations of the reliability, accuracy, and performance of our tests, or 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\u2019s 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<\/a> and www.sec.gov<\/a>.<\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260618969671\/en\/<\/a><\/span><\/p>\n
Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com<\/a>
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com<\/a><\/p>\nKEYWORDS:<\/b> Texas United States North America<\/p>\n
INDUSTRY KEYWORDS:<\/b> Oncology Health Genetics Research Science Biotechnology<\/p>\n
- Patients with persistently low Prospera dd-cfDNA levels had reliable and significantly lower adverse outcome rates, which may enable confident decisions to lower immunosuppression. In a new analysis of 989 kidney transplant recipients from the ProActive study<\/b>, when a patient\u2019s Prospera dd-cfDNA donor-fraction remained <0.5%, patients had significantly lower rates of adverse outcomes, including ~12X reduced odds of future rejection and ~5.5X reduced odds of future graft loss. These results demonstrate that low Prospera dd-cfDNA was prognostic of durable graft stability and reiterate the importance of ongoing and regular monitoring.<\/li>\n<\/ul>\n
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