Latest news with #AmericanJournalofTransplantation
Yahoo
01-08-2025
- Business
- Yahoo
Natera Highlights Latest Prospera™ Data at WTC 2025; 16 Abstracts Including Five Oral Presentations
High-impact datasets across heart, kidney and lung at WTC follows two major publications in the American Journal of Transplantation in the last three months AUSTIN, Texas, August 01, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that it will present several new datasets at the 2025 World Transplant Congress (WTC), taking place August 2 - 6 in San Francisco, CA. The presentations span kidney, heart and lung transplantation and represent one of the most comprehensive collections of data on Natera's Prospera test to date. Highlights include five oral presentations and 11 poster sessions featuring evidence from high-impact studies that support the use of Natera's products, such as: Multiple abstracts from the Trifecta series of studies, including three oral presentations which evaluated Prospera's performance across kidney, heart and lung transplantation. Two posters tied to recently published studies in the American Journal of Transplantation: (1) The prospective, multi-center PEDAL clinical trial, which demonstrated Prospera Kidney's ability to predict long-term outcomes following rejection; and (2) a study on Prospera Heart with Donor Quantity Score (DQS), highlighting its robust performance in detecting allograft rejection. An oral presentation detailing Prospera Kidney's utility in monitoring treatment of chronic antibody-mediated rejection with anti-CD38 monoclonal antibody therapy. These findings were published earlier this month in Kidney International Reports. "We are proud to share 16 presentations across kidney, heart and lung at this major global conference," said Sangeeta Bhorade, M.D., chief medical officer of organ health at Natera. "These new presentations and recent peer-reviewed publications underscore the clinical value of Prospera and affirm our leadership in advancing transplant care through innovation and science." Full list of presentations at WTC include: August 3, 5:35 PM PT | Presentation # OA11.8 (Oral Presentation)Presenter: Patrick T. Gauthier, Study: dd-cfDNA Correlates with T Cell-Mediated Rejection and Parenchymal Injury in Mucosal Biopsies of Lung Transplants August 4, 3:30 PM PT | Presentation # P2.07.92Presenter: Vasanthi Balaraman, of Broad Gene Panel for Kidney Disease in Kidney Transplant Donor Selection: A Case Study August 4, 3:30 PM PT | Presentation # P2.07.165Presenter: Yasar Caliskan, Regarding Use of Genetic Testing in Living Donor Candidate Evaluation: A Survey of US Transplant Center Staff August 4, 3:30 PM PT | Presentation # P2.07.198Presenter: Katelynn S. Madill-Thomsen, All DSA Positive Allows Existing Banff Guidelines to Diagnose Many More Cases of Histologic ABMR Currently Missed Only Because They Are DSA-Negative August 4, 4:41 PM PT | Presentation # OA18.2 (Oral Presentation)Presenter: Krista Lentine, M.D., Practice and Challenges in Managing the Costs of Kidney Paired Donation: A Survey of US Transplant Professionals August 5, 3:30 PM PT | Presentation # P3.03.50Presenter: Suphamai Bunnapradist, the Response to Treatment of Kidney Allograft Rejection with Donor-Derived Cell-Free DNA August 5, 3:30 PM PT | Presentation # P3.03.55Presenter: Paul J. Kim, M.D.A Two-Threshold Algorithm Using Donor-Derived Cell-Free DNA Fraction and Quantity to Detect Acute Rejection After 21 Days Post Heart Transplantation August 5, 3:30 PM PT | Presentation # P3.03.56Presenter: Alan Betensley, M.D., BSE, FCCPMonitoring Changes in Donor-Derived Cell-Free DNA Levels in Treated Lung Allograft Rejection: Pilot Data August 5, 3:30 PM PT | Presentation # P3.03.57Presenter: David J. Ross, M.D., FCCP, FASTCell-Free DNA Does Not Discriminate Acute Rejection from Infection After Lung Transplant: Pilot Study August 5, 3:30 PM PT | Presentation # P3.03.58Presenter: Katherine Vandervest, M.D.'Baseline Lung Allograft Dysfunction' is Associated with Different Cell-Free DNA Dynamics After Lung Transplantation August 5, 3:30 PM PT | Presentation # P3.03.59Presenter: Eileen Hsich, Cell-Free DNA is Not Associated with White Blood Cell Count in Heart Transplant Recipients August 5, 3:30 PM PT | Presentation # P3.03.60Presenter: Navchetan Kaur, of dd-cfDNA Levels in Patients Undergoing Repeat Kidney Transplantation August 5, 3:30 PM PT | Presentation # P3.07.177Presenter: Ziad S. Zaky, Machine Learning with Dynamic Time Warping Helps Understand Longitudinal dd-cfDNA Trajectories in Kidney Transplant Patients August 5, 4:41 PM PT | Presentation # OA36.2 (Oral Presentation)Presenter: Katelynn S. Madill-Thomsen, Relationships Among Tests for Heart Transplant Antibody-Mediated Rejection August 6, 8:44 AM PT | Presentation # OA50.4 (Oral Presentation)Presenter: Katelynn S. Madill-Thomsen, the Hierarchy of Relationships Among Tests for Kidney Transplant Antibody-Mediated Rejection August 6, 9:20 AM PT | Presentation # OA50.8 (Oral Presentation)Presenter: Wai-Choong Lye, Monoclonal Antibody Daratumumab for the Treatment of Chronic Active-Antibody Mediated Kidney Allograft Rejection About NateraNatera™ 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 supported by more than 300 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. For more information, visit Forward-Looking StatementsAll 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, 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's 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 and View source version on Contacts Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@ Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@ Sign in to access your portfolio
CNN
16-05-2025
- Health
- CNN
Dr. Sanjay Gupta: At the forefront of organ transplants, patients are the pioneers
EDITOR'S NOTE: Watch 'Dr. Sanjay Gupta Reports: Animal Pharm' on Sunday, May 18 at 8 p.m. ET/PT on CNN. The story of transplants has always been one of altruism. After all, organs can be neither sold nor purchased. They can only be donated as a gift of life. It is a story that started in 1954, when Dr. Joseph Murray performed the world's first successful organ transplant at Boston's Peter Bent Brigham Hospital between identical twin brothers Ronald and Richard Herrick. Richard had been discharged from the US Coast Guard after being diagnosed with end-stage kidney disease, and his identical twin brother, Ronald, was a willing donor. Although they had no certainty it would work, the transplant resulted in eight more years of life for Richard, successful in part because they had the same DNA. When Ronald died in 2010, Dr. Murray remembered him in a statement published in the American Journal of Transplantation, saying: 'we should never forget that he not only saved his brother Richard's life, but also paved the way for thousands of other transplant recipients throughout the world.' It is this same ethos that is now pushing forward the burgeoning field of xenotransplantation – the practice of using animal organs for human transplant. For the past two years, I've spoken with surgeons, genetic engineers and patients who have all told me of the hope of using genetically engineered pig donors to help end the organ shortage crisis. In the United States alone, there are more than 100,000 people waiting for an organ at any given moment – most of them in need of a kidney. Every day, 17 people on that list will die, just waiting. 'This paradigm that someone has to die in order for somebody to live is, a broken paradigm. It just doesn't work,' said Dr. Robert Montgomery, director of the NYU Langone Transplant Institute. As both a transplant surgeon and a heart transplant recipient himself, he knows how agonizing the wait can be. It's why he's relentlessly pushing for a new source of organs. 'Because less than 1% of the people who die every year die in a way that they could ever even be considered as organ donors, we need a sustainable, renewable source of organs from something else other than humans dying,' Dr. Montgomery told me. In many ways, the idea of using pigs is not all that far-fetched. After all, we have been using pig heart valves to replace human valves since the 1970s. The drugs heparin and insulin were initially derived from pigs. Because of their similarity in size to humans, a pig's organs are a pretty good match for us. And our long history of breeding them and their ability to produce large litters in just under four months makes them a reliable, steady and speedy source of potential organs. It was the more recent development of CRISPR and genetic engineering that has truly accelerated the field of xenotransplantation. Scientists can now modify a pig's DNA so that its organs are more compatible for human transplant, controlling for rejection, growth and possible viruses. But just as with the Herrick brothers, all of this heady science requires pioneering patients willing to take the chance and raise their hands despite the unknowns. Sixty-six-year-old Tim Andrews had been on dialysis for two years. He had end-stage kidney disease, and the likelihood that he would get a transplant was extremely low in part because of his rare blood type. Doctors put the chances of him finding a match within the next five years at just 9%. The likelihood of him dropping off the list altogether in that same time period because of illness or death was nearly 50%. Dialysis had worn on Tim so much that he had resigned himself to the idea that he might literally die in the dialysis chair. For those not on dialysis, it can be hard to understand just how grueling it can be, both mentally and physically. But think of it like this: Our kidneys are always working, filtering blood 24/7. A dialysis machine tries to do all that work, but compresses it into three or four days a week, a few hours each time. It was so stressful on Tim's body that he had a heart attack six months after starting dialysis. When he learned that his hospital, Massachusetts General Hospital, had performed the first experimental pig kidney xenotransplant, he told his doctor, Dr. Leonard Riella, that he had to be given a chance. Even though he knew there was tremendous uncertainty about the outcome of the transplant, Tim pushed forward. When I visited Tim and his wife, Karen, at their home in Concord, New Hampshire, he told me, 'It may shorten your life, but you're going to do something for humanity. And I'm like, oh, God, that's what it's all about.' At the time, 53-year-old Towana Looney was the only person in the world who could understand what Tim was contemplating. Twenty-five years earlier, Towana had donated one of her kidneys to her mom, but two years later, she developed pre-eclampsia during pregnancy, and her remaining kidney was damaged. Like Tim, she was unlikely to find a match anytime soon, in her case because of high antibodies. She had been on grueling dialysis for eight years before undergoing the transplant in November 2024 at NYU Langone. Dr. Montgomery was her transplant surgeon. Her life was transformed, and when I saw this vibrant womaen on stage talking about her experience, I was amazed at how healthy she looked. Afterward, Dr. Montgomery told me, 'She wants to start a revolution.' In April of this year, Towana had to have her kidney removed after she developed an infection unrelated to the organ that required her immunosuppression regimen to be lowered. At the time, she had lived with the genetically modified pig organ for 130 days, the longest period of time ever recorded. In a statement, Towana said, 'I'm so grateful to have been given the opportunity to be part of this incredible research. For the first time since 2016, I enjoyed time with friends and family without planning around dialysis treatments. Though the outcome is not what anyone wanted, I know a lot was learned from my 130 days with a pig kidney—and that this can help and inspire many others in their journey to overcome kidney disease.' These are still early days, and so there will be ups and downs, but in science, like life, you learn just as much from the failures as the successes. Each step forward has been building on the lessons learned from previous patient pioneers, like David Bennett and Lawrence Faucette. They both received pig hearts and lived an additional six to eight weeks. Rick Slayman and Lisa Pisano received pig kidneys in 2024, and both lived about two additional months after their procedures. In each case, their stories taught scientists valuable and transformative lessons about the field of xenotransplantation. This spring, I had a chance to visit with Brittany Rydel, Lisa Pisano's daughter. She told me, 'My mom always cared about other people. And one of the first things she said to me was, 'Even if this doesn't work for me, it can work for someone else.' And I think about that a lot. You know, I might need a kidney one day. My kids might need a kidney one day. ' The baton of altruism and hope passed on again. So often, it is the scientists and the researchers who are recognized – and for good reason. After all, the story of xenotransplantation is possible because of several Nobel Prize-winning discoveries, including transplanation, gene editing, cloning, IVF and immunology. As Dr. Montgomery told me, 'We stand on the shoulders of giants for sure.' The real giants propelling this field forward, however, are the patients bravely stepping into the unknown for the benefit of all of us.
Yahoo
07-05-2025
- Health
- Yahoo
Prospera™ Heart Test with DQS Outperforms dd-cfDNA Percentage in Detecting Allograft Rejection, New AJT Publication Shows
Study published in American Journal of Transplantation highlights strong sensitivity and specificity, along with a >37% reduction in false positives when using Prospera Heart with DQS Adds to the growing body of evidence supporting DQS for dd-cfDNA analysis in solid organ transplant AUSTIN, Texas, May 07, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that the American Journal of Transplantation (AJT) published a new study1 evaluating the performance of Prospera Heart with DQS to detect allograft rejection. Prospera with DQS leverages a two-threshold algorithm, combining the traditional donor fraction (dd-cfDNA %, measuring dd-cfDNA as a fraction of total cfDNA) and donor quantity score (DQS, estimating the total quantity of dd-cfDNA in the blood). This method delivers a single result for risk assessment of both antibody mediated rejection (AMR) and acute cellular rejection (ACR). In the study, 808 Prospera Heart test samples were obtained from 187 heart transplant patients alongside paired endomyocardial biopsies. Prospera with DQS was compared to dd-cfDNA %-alone to assess the detection of biopsy-proven allograft rejection. The study highlights the following performance improvements demonstrated by Prospera with DQS, including: Sensitivity increased from 78.2% to 86.5%. Specificity increased from 76.9% to 83.6%. Area under the curve (AUC) increased from 0.865 to 0.881 A reduction in false positive cases of 37.3% "This publication provides evidence that combining dd-cfDNA % with DQS improves the accuracy of dd-cfDNA testing for acute rejection over dd-cfDNA %-alone," said Josef Stehlik, M.D., M.P.H., one of the study investigators and medical director of the Heart Transplant Program and co-chief of the Advanced Heart Failure Program at the University of Utah. "It is encouraging to see that this novel approach significantly reduced false positive results and will help to obviate unnecessary biopsies in clinical care. This is another step in providing enhanced care for heart transplant patients using noninvasive tools to determine risk of rejection." This data confirms the growing body of evidence for the utilization of DQS when analyzing dd-cfDNA in solid organ transplant, including a study evaluating DQS in kidney transplant (Halloran et al). Natera has also demonstrated the value of DQS in the supplemental data from its 2022 DEDUCE study2 in Prospera Heart, as well as recently announced data from the DEFINE-HT study.
Yahoo
14-04-2025
- Health
- Yahoo
Alabama lawmakers filed a bill allowing unvaccinated people to be on the organ donation list
ALABAMA (WDHN) – Alabama lawmakers at the house have filed a bill that will prevent health care providers from interfering on the donation of an organ over a person's vaccine status. Alabama state Representative, Ernie Yarbrough of Trinity, filed this bill to help people who decide not to get vaccinated the opportunity to be on the organ donation list in Alabama. The bill is also called The Adaline Deal Act, in honor of the 12-year-old girl from Indiana, who is distantly related to Vice President JD Vance. Deal's parents said she has been restricted a spot on the heart transplant list because she has not been vaccinated against COVID-19 and the flu. Her mother, Jeneen said she believes the vaccinations are unsafe. The couple adopted Adaline from China when she was 4 years old, and she was born with two hear conditions. The family start a GoFundMe for her condition, and they said they're using the money to take her to a different transplant center that won't require her to be vaccinated. According to the American Journal of Transplantation, Transplant centers set their own vaccine requirements. Under this newly filed bill, Alabama's Attorney General would be authorized to push a $50,000 fine against any person that denied an organ donation due someone not being vaccinated. The bill is currently awaiting action at the House Committee on Health. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
