Acute cellular graft rejection

Donor Quantity Score (DQS) technique is unique to Natera, improving detection of both acute cellular rejection and antibody-mediated rejection AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of Prospera Heart™ with Donor Quantity Score (DQS), further enhancing Prospera’s ability to detect rejection in heart transplant patients. 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. Prospera Heart now incorporates a second metric – the DQS – that normalizes for the background total cfDNA. Prospera Heart with DQS combines the traditional donor fraction and the new DQS into a two-threshold algorithm, delivering a single result with more accurate risk assessment for both antibody mediated rejection (AMR) and acute cellular rejection (ACR). “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 Prospera Heart by introducing this two-threshold algorithm to better serve the transplant community.” A study performed at the University of Utah and the University of California San Diego showed that incorporating DQS enhanced the performance of Prospera Heart in screening for biopsy-proven active rejection. In an initial analysis of 703 plasma samples, the two-threshold algorithm, as compared to the traditional dd-cfDNA % alone, improved several key performance metrics as follows: Sensitivity increased from 80.0% to 88.2% 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 International Society for Heart and Lung Transplantation’s annual meeting in April 2024, and it will be submitted for peer-reviewed publication later this year. “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 Josef Stehlik, M.D., M.P.H., Medical Director of the Heart Transplant Program and Co-chief of the Advanced Heart Failure Program at the University of Utah Hospital. “We believe this innovative technique can lead to fewer unnecessary biopsies and follow-up procedures for heart transplant recipients given the increase in sensitivity.” A similar two-threshold dd-cfDNA test for assessing the risk of kidney transplant rejection, Prospera Kidney with Quantification, was published in the Journal of the American Society of Nephrology1 and has been offered by Natera for kidney transplant patients since 2021. 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 Austin, Texas and San Carlos, California. For more information, visit . 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 SEC from time to time. These documents are available at and . References Bunnapradist S, Homkrailas, P, Ahmed, E, et al. Using both the fraction and quantity of donor-derived cell-free DNA to detect kidney allograft rejection, J Amer Soc Nephrology 2021; 32(10): 2439-2441.

HeartCare Results Effectively Stratified Patients at Highest Risk for Acute Cellular Rejection Cardiologists Performed the Fewest Biopsies After Dual Negative HeartCare Results Compared to Single or Dual Positive Results Two-Year Clinical Outcomes Data Demonstrate Excellent Survival and Allograft Function BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced findings from the SHORE (Surveillance HeartCare Outcomes Registry) study, one of the largest heart transplant studies of its kind, published in The Journal of Heart and Lung Transplantation. The prospective observational study demonstrates that HeartCare® which combines AlloSure® Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap® Heart gene-expression profiling (GEP), identifies acute cellular rejection in heart transplant patients better than dd-cfDNA testing alone and is associated with fewer biopsies and excellent clinical outcomes.1 Key Findings from the SHORE Study Publication1: Dual-positive HeartCare results are associated with the highest incidence (9.2%) of acute cellular rejection (ACR), whereas dual-negative HeartCare results are associated with the lowest incidence (1.5%) of ACR. Follow-up endomyocardial biopsies (EMB) are performed at the lowest rate (8.8%) following a dual-negative HeartCare result, and at the highest rate (35.4%) following a dual positive HeartCare result. The rate of biopsies performed in response to a single positive result is 56% lower than dual-positive HeartCare results. Clinician behavior to HeartCare results changed over time as centers gained experience with the testing. By the end of the study cardiologists performed 10% fewer biopsies in the first year post-transplant and 40% fewer in the second year post-transplant despite an increase in follow-up biopsy rates for dual positives. Excellent clinical outcomes were observed in patients managed with HeartCare including fewer follow-up endomyocardial biopsies, 95% survival and 97% with normal allograft function at two years post-transplantation. “This large, prospective, multicenter study demonstrates that HeartCare significantly improves clinicians’ ability to assess acute cellular rejection risk and its use is associated with lower biopsy rates and excellent clinical outcomes two-years post-transplant,” said John W. Hanna, CareDx President and CEO. “The SHORE study confirms the superior performance of dual molecular testing, combining donor-derived cell-free DNA and gene-expression profiling for acute cellular rejection surveillance in optimizing care for heart transplant patients. This approach allows for refined patient selection for surveillance biopsies, leading to fewer invasive procedures over time while maintaining vigilant ACR monitoring, and achieving excellent clinical outcomes,” said Kiran Khush, MD, MAS, Cardiologist, Professor of Cardiovascular Medicine, Stanford Medicine. One of the largest heart transplant studies of its kind, SHORE is a prospective 67-center, observational study of over 2,700 heart transplant patients in the United States receiving non-invasive molecular testing with AlloSure Heart dd-cfDNA and AlloMap Heart GEP or HeartCare. Together, these different molecular tests offer a more comprehensive evaluation of a patient’s heart transplant status by assessing both allograft health and immune system activity. The published study was designed to evaluate the utility of combined molecular testing using HeartCare for acute cellular rejection (ACR) surveillance. To read the publication, go here. About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: . Forward-Looking Statements This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with HeartCare, which combines AlloSure Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap Heart gene-expression profiling (GEP). These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of HeartCare, which combines AlloSure Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap Heart gene-expression profiling (GEP); risks that the findings in the SHORE study supporting the data may be inaccurate, general economic and market factors; and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the quarterly report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. References: 1. Khush K, Hall S, Kao A, et al. Surveillance with Dual Non-invasive Testing for Acute Cellular Rejection After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE). The Journal of Heart and Lung Transplantation. Published online May 15, 2024. DOI: View source version on businesswire.com: Contacts CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com Investor Relations Greg Chodaczek investor@caredx.com Source: CareDx, Inc. View this news release online at:

Record Number of 65 Abstracts Showcasing CareDx Innovation Including Data Showing Clinical Utility of AlloSure Kidney to Guide Immunosuppression Management Experts Review Advancements in Artificial Intelligence and Molecular Diagnostics During CareDx Symposium BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced a leading presence at the 2023 American Transplant Congress (ATC) with 65 scientific presentations. CareDx will also be hosting a satellite symposium1 and sponsoring the Women’s Networking Event. The ATC meeting takes place June 3-7 in San Diego, California. "We are proud to showcase our leadership with our highest-ever number of abstracts at the 2023 Transplant Congress with data that not only validates the performance of AlloSure® and AlloMap® but also demonstrates their clinical utility in the surveillance and management of patients,” said Reg Seeto, CEO and President of CareDx. “We're also excited to have assembled a world-class panel of experts to describe the latest innovations in transplantation including the additive clinical value of incorporating our molecular biomarkers into artificial intelligence tools to drive earlier insights regarding a patient’s risk of rejection for more personalized, preventative care.” Noteworthy Presentations AlloSure Kidney AlloSure donor-derived cell-free DNA (dd-cfDNA) and blood gene expression profiling used to guide immunosuppression minimization in patients on belatacept maintenance (B204). AlloSure used for immunologic surveillance of calcineurin inhibitor (CNI) intolerant patients and to guide transition to belatacept therapy (C145). Tissue gene expression and AlloSure Kidney used to guide treatment in patients presenting with T-Cell Mediated Rejection (TCMR) (oral abstract #73). Multinational multi-center validation of a predictive model showing the clinical value of adding AlloSure Kidney to assess patient risk of clinical and subclinical rejection (oral abstract #91). AlloSure dd-cfDNA provides less invasive monitoring for allograft function and survival. A combination of AlloSure, serum creatinine and biopsy can improve early detection of subclinical rejection and predict graft failure (C127). HeartCare (AlloSure and AlloMap) One-year outcomes of patients on rejection surveillance protocol utilizing dd-cfDNA resulted in patients receiving significantly fewer biopsies and fewer treated rejection episodes, and had no difference in survival compared to patients on biopsy surveillance (oral abstract #30). Additionally, by using AlloSure dd-cfDNA, a heart transplant center was able to perform only one surveillance biopsy per patient without an increase in morbidity or mortality (BLB017). Greater elevations of AlloSure Heart and AlloMap Heart were associated with higher grades of biopsy confirmed Acute Cellular Rejection (ACR) (oral abstract #31). AlloSure Lung Abstracts AlloSure Lung dd-cfDNA and plasma inflammatory markers can predict CLAD risk equivalent to or better than an invasive biopsy (oral abstract #33). For a complete list of abstracts by title and presentation date and time, please follow this link. Satellite Symposium1 Leading experts will discuss the latest advancements in kidney and heart transplantation during a symposium hosted by CareDx titled, “An Evolving Standard of Care: Artificial Intelligence and Molecular Diagnostics”. It will be held on Monday, June 5, from 12:15 to 1:15pm PT. Speakers include: Jonathan Bromberg, MD, PhD, Professor of Surgery, University of Maryland Giselle Guerra, MD, Medical Director, Transplant Services, Kidney Transplant Program, Miami Transplant Institute Gaurav Gupta, MD, Interim-Chair, Division of Nephrology, Medical Director, Kidney Transplant Program, Virginia Commonwealth University Health Jeffrey Teuteberg, MD, Professor of Medicine, Section Chief of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support, Stanford University “I’ve been a long-standing proponent of using non-invasive molecular diagnostics such as dd-cfDNA for surveillance to help overcome the inherent limitations of functional parameters and tissue biopsies in detecting early signs of rejection and for immunosuppression management,” said Giselle Guerra, MD, Medical Director, Transplant Services, Kidney Transplant Program, Miami Transplant Institute. “I look forward to sharing findings from my clinical practice on utilizing dd-cfDNA to make more personalized immunosuppression treatment decisions based on a patient’s risk stratification.” About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: . Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloSure, AlloMap and HeartCare, as well as CareDx’s leading participation at the 2023 ATC meeting (the “ATC Participation”) and its hosting of a satellite symposium to discuss the latest advancements in kidney and heart transplantation (the “Symposium”). These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSure, AlloMap, HeartCare, its ATC Participation or its hosting of the Symposium; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by CareDx with the SEC on February 27, 2023, the quarterly report on Form 10-Q for the quarter ended March 31, 2023 filed by CareDx with the SEC on May 10, 2023, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. References This symposium is not part of the ATC official educational program, and the sessions and content are not endorsed by ATC. View source version on businesswire.com: Contacts CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com Investor Relations Greg Chodaczek investor@caredx.com Source: CareDx, Inc. View this news release online at: