CareDx Announces Landmark KOAR Study Published in the American Journal of Transplantation
The KOAR study enrolled 1,743 patients across 56 U.S. transplant centers to evaluate the clinical utility of a dd-cfDNA surveillance protocol based on the DART study, which prescribed seven tests in year one and four annually in years two and three. A total of 18,584 AlloSure tests were obtained from the overall cohort.
'The scale and clarity of KOAR make it a landmark,' said Daniel C. Brennan, MD, Professor of Medicine at Johns Hopkins, author of the publication, and the senior author of the primary DART publication. 'In fact, it shows that dd-cfDNA should be considered the first-line test even before DSA. It's arguably the most powerful biomarker we have in kidney transplantation today.'
'KOAR confirms that dd-cfDNA is a clinically actionable tool that enhances how we detect and manage rejection,' said Jonathan S. Bromberg, MD, PhD, Professor of Surgery at the University of Maryland, lead author of the publication, and a key author on the DART publications. 'Importantly, it helps clinicians tailor care based on risk.'
Key findings include:
Elevated AlloSure was associated with a 6-fold increase in rejection yield in surveillance biopsies (39% vs. 7%, p<0.001) and a 4-fold increase in for-cause biopsies (47% vs. 12%, p<0.001).
AlloSure elevations were detectable up to four months before ABMR and one month before TCMR, supporting its role in early detection and longitudinal monitoring.
In post-biopsy monitoring, AlloSure levels declined significantly following treatment, while serum creatinine remained unchanged, reinforcing AlloSure's role in assessing treatment response.
The study also demonstrated that dd-cfDNA levels correlate with rejection severity, with higher levels associated with ABMR and mixed rejection, and lower levels linked to borderline or TCMR 1A. This stratification capability positions AlloSure as a critical tool for tailoring immunosuppression and biopsy decisions based on individual patient risk.
'The KOAR study provides compelling evidence that dd-cfDNA can optimize biopsy utilization and improve clinical decision-making in kidney transplant care,' said Robert Woodward, Chief Scientific Officer of CareDx. 'AlloSure empowers physicians to detect rejection earlier and intervene more precisely, to achieve the ultimate goal of improving long-term graft survival.'
The full publication is available online at: https://www.amjtransplant.org/article/S1600-6135(25)02875-8/fulltext
About CareDx
CareDx, Inc., headquartered in Brisbane, California, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. For more information, visit www.caredx.com.
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 Kidney. 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 Kidney; risks that the findings in the KAOR study supporting the data may be inaccurate, general economic and market factors; risks that the findings in the studies 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, 2024 filed by CareDx with the SEC on February 28, 2025, 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. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
27 minutes ago
- Business Wire
BlinkRx Launches 'Operation Access Now' to Accelerate and Scale Direct‑to‑Patient and Direct‑to‑Business Programs
NEW YORK--(BUSINESS WIRE)-- BlinkRx, the nation's leading prescription lifecycle management platform, today announced the launch of Operation Access Now, a rapid deployment initiative that enables pharmaceutical manufacturers to build and launch direct-to-patient (DTP) and direct‑to‑business (DTB) channels that expand medication access and deliver pricing transparency in as little as 21 days. This program comes at a moment of growing urgency across the life sciences industry. As traditional access models struggle to meet patient and provider expectations, leading brands are turning to faster, more scalable approaches. BlinkRx's national infrastructure already supports millions of patients across all 50 states. The platform's patient-centric design removes every barrier for patients to start and stay on therapy and delivers significant lift for brands: on average, 52% more patient starts and 41% more fills per patient. With Operation Access Now, the initiative enables: Rapid Stand‑Up: DTP programs that can be operational in as little as 21 days, thanks to BlinkRx's turnkey platform and flexible rules engine. Future-Proof: A modular platform that allows pharmaceutical manufacturers to start with a DTP solution and expand into future capabilities as needs and regulations change. For example, the platform can be deployed for DTB models, and can service both cashpay and insurance patients. Scale: Unique automation capabilities that enable pharmaceutical manufacturers to effortlessly scale based on patient demand and adoption. Legacy DTP solutions, such as copay cards and standalone cash pharmacies, are often costly, inefficient, and prone to patient and physician frustration- causing delays in access, misuse, and poor experiences. BlinkRx's platform addresses these ecosystem issues while ensuring strict regulatory compliance. 'Operation Access Now is about removing every barrier between manufacturers and the patients who need their therapies,' said Geoffrey Chaiken, Co‑Founder and CEO of BlinkRx. 'We're prepared to enable manufacturers to deploy DTP programs and deliver the speed, scale, and flexibility the market demands.' About BlinkRx
Business Wire
an hour ago
- Business Wire
BostonGene Named 'AI-based Drug Discovery Solution of the Year' in 2025 AI Breakthrough Awards Program
BUSINESS WIRE)-- BostonGene, a leader in AI-powered solutions for drug discovery and development, has been honored with the 'AI-based Drug Discovery Solution of the Year' award in the 8 th annual AI Breakthrough Awards program. AI Breakthrough is a leading market intelligence organization that recognizes the top companies, technologies and products in the global Artificial Intelligence (AI) market. 'BostonGene's AI platform delivers powerful, accurate and reproducible biological signatures that represent an enhanced approach drug development - bringing precision oncology closer to clinical reality.' BostonGene's breakthrough AI platform is transforming oncology research and drug development by integrating high throughput tissue analytics with genomic, transcriptomic and clinical data. This multimodal approach creates biological signatures, leading to improved target identification and enhanced patient stratification for clinical trials. As part of its integrated solution, BostonGene's novel AI-driven platform combines advanced digital pathology capabilities–such as pixel-level analysis of whole slide images–with molecular and clinical data. The insights that BostonGene's platform delivers sharpen the precision of predictive biomarker and therapeutic target discovery. 'BostonGene's AI platform stands out for its ability to synthesize clinical, molecular and imaging data–generating comprehensive, actionable insights that drive drug development and precision oncology,' said Steve Johansson, managing director, AI Breakthrough. 'BostonGene's AI platform delivers powerful, accurate and reproducible biological signatures that represent an enhanced approach drug development - bringing precision oncology closer to clinical reality.' 'Through our strategic collaborations with leading cancer centers and pharmaceutical companies, we are integrating advanced technology like AI into oncology care,' said Ferran Prat, PhD, JD, Chief Commercial Officer at BostonGene. 'We're grateful to AI Breakthrough for the 'AI-based Drug Discovery Solution of the Year' award, and we will continue to focus on using innovative AI-powered solutions to revolutionize personalized cancer treatment, expedite drug development and improve patient outcomes.' The AI Breakthrough Awards shine a spotlight on the boldest innovators and most impactful technologies that are leading the charge in AI across a comprehensive set of categories, including Generative AI, Computer Vision, AIOps, Agentic AI, Robotics, Natural Language Processing, industry-specific AI applications and many more. This year's program attracted more than 5,000 nominations from over 20 different countries, underscoring the explosive growth and global importance of AI as a defining technology of the 21st century. About BostonGene Corporation BostonGene helps drug developers de-risk and accelerate research and development using a clinically validated AI platform purpose-built for oncology and supported by a CLIA-certified and CAP-accredited clinical laboratory. By integrating advanced molecular and immune profiling with clinical data, we uncover actionable insights that inform trial design, optimize patient selection and improve clinical outcomes. Our diagnostic and treatment recommendation solutions are used in clinical settings to personalize care and guide therapy decisions for patients. For more information, visit About AI Breakthrough Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the AI Breakthrough Awards program is devoted to honoring excellence in Artificial Intelligence technologies, services, companies and products. The AI Breakthrough Awards provide public recognition for the achievements of AI companies and products in categories including Generative AI, Machine Learning, AI Platforms, Robotics, Business Intelligence, AI Hardware, Computer Vision and more. For more information visit Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose.
Business Wire
an hour ago
- Business Wire
Genmab Announces Phase 3 EPCORE ® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)
COPENHAGEN, Denmark--(BUSINESS WIRE)-- Genmab A/S (Nasdaq: GMAB) today announced positive results of the Phase 3 EPCORE ® FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R 2) versus R 2 alone for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study met its dual primary endpoints of overall response rate (ORR, p-value < 0.0001) and progression-free survival (PFS, HR 0.21, p-value <0.0001), demonstrating statistically significant and clinically meaningful differences in both endpoints, reducing the risk of disease progression or death by 79%. The results, derived from a pre-planned interim analysis, will be submitted for presentation at the 67 th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will serve as the basis for global regulatory submissions. Separately, on July 24, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R 2 following at least one prior systemic therapy. The sBLA submission was based on data from a first interim analysis that demonstrated statistically significant improvements in ORR (95.7%, p-value < 0.0001) and PFS (HR 0.21, p-value <0.0001, based on the intent-to-treat population). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 30, 2025. If approved, epcoritamab plus R 2 would be the first bispecific antibody combination regimen available in the U.S. as a second-line treatment option for patients with R/R FL. 'While therapeutic options exist for patients with relapsed or refractory follicular lymphoma, response rates tend to decline and durability diminishes with each subsequent line of treatment, which can increase the risk of the disease transforming into aggressive large-cell lymphoma,' said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. 'The results from this trial, and the decision from the FDA to accept the sBLA for priority review, demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape and reinforces our shared commitment with AbbVie to advance epcoritamab as a potential core therapy across B-cell malignancies.' The safety profile of epcoritamab in combination with R 2 in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens (epcoritamab and R 2) and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed. The U.S. FDA has granted accelerated approval of single agent epcoritamab for the treatment of adults with R/R FL after two or more lines of systemic therapy. The U.S. FDA also granted Breakthrough Therapy Designation (BTD) to epcoritamab in combination with R2 for the treatment of adult patients with R/R FL who have received at least one prior line of therapy. The safety and efficacy of epcoritamab in combination with R2 in R/R FL is currently being evaluated in clinical trials and is not approved or established in the U.S., EU or in any other territory. About Follicular Lymphoma (FL) FL is typically an indolent (or slow-growing) form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30 percent of all cases. i About 15,000 people develop FL each year in the U.S. ii and it is considered incurable with current standard of care therapies. iii Patients often relapse and, with each relapse the remission and time to next treatment is shorter. iv Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients. v About the EPCORE FL-1 Trial EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R 2) versus R 2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The dual primary endpoints are ORR and PFS assessed by independent review committee (IRC) per Lugano criteria. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody ® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. vi Epcoritamab (approved under the brand name EPKINLY ® in the U.S. and Japan, and TEPKINLY ® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit for more information. EPKINLY ® (epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATION Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Full Prescribing Information and Medication Guide, including Important Warnings. Globally, prescribing information varies; refer to the individual country product label for complete information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO ®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. This Company Announcement contains forward looking statements. The words 'believe,' 'expect,' 'anticipate,' 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ®; the Y-shaped Genmab logo ®; Genmab in combination with the Y-shaped Genmab logo ®; HuMax ®; DuoBody ®; HexaBody ®; DuoHexaBody ®, HexElect ® and KYSO™. EPCORE ®, EPKINLY ®, TEPKINLY ® and their designs are trademarks of AbbVie Biotechnology Ltd. _____________________________________________ i Lymphoma Research Foundation official website. Accessed November 2024. ii Leukemia & Lymphoma Society. Accessed November 2024. iii Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421. iv Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708. v Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5165-9. doi: 10.1200/JCO.2008.16.0283. Epub 2008 Oct 6. PMID: 18838711. vi Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine
