CareDx Showcases Extensive Clinical Evidence for Transplant Monitoring Solutions at ISHLT 2025
• CareDx presented 60 abstracts including 19 oral presentations at the 2025 ISHLT meeting, demonstrating the growing clinical adoption of their transplant monitoring solutions across 92 transplant centers.
• New findings from the SHORE study revealed that HeartCare is prognostic of long-term graft outcomes independent of biopsy results and is being used by clinicians to guide immunosuppression management decisions.
• Data from the ALAMO study showed AlloSure Lung may predict development of Chronic Lung Allograft Dysfunction (CLAD) and effectively monitors acute cellular rejection and treatment response in lung transplant patients.
CareDx Expands AlloSure Testing to Pediatric Heart and Simultaneous Pancreas-Kidney Transplant Patients
• CareDx has received New York State Clinical Laboratory Evaluation Program approval for AlloSure testing in pediatric heart transplant patients of all ages, including infants, and in simultaneous pancreas-kidney transplant recipients.
• Studies show AlloSure Heart can detect rejection in pediatric patients with performance consistent with adults, demonstrating an 81% reduction in surveillance biopsies in a prospective study.
• The expanded indications address critical needs in transplant care, particularly for the approximately 450 pediatric heart transplants and 700 simultaneous pancreas-kidney transplants performed annually in the U.S.
GLP-1 Agonists Show Significant Benefits for Kidney Transplant Recipients with Type 2 Diabetes
• A landmark study by NYU Langone Health reveals kidney transplant recipients with type 2 diabetes who take GLP-1 agonists experience 49% lower risk of organ failure and 31% reduced mortality within five years.
• While the anti-obesity medications demonstrated substantial benefits, researchers observed a 49% increased risk of diabetic retinopathy, highlighting the need for careful eye health monitoring in these patients.
• The comprehensive analysis of 18,016 kidney transplant recipients provides the strongest evidence to date supporting GLP-1 agonists as safe and effective tools for managing diabetes in transplant patients.
FDA Approves Genentech's TNKase for Acute Ischemic Stroke with Simplified Administration
• The FDA has approved Genentech's TNKase, a clot-dissolving agent, for treating acute ischemic stroke in adults, marking the company's second stroke treatment approval.
• TNKase offers a streamlined five-second intravenous bolus administration, presenting a significant advantage over the current standard treatment Activase's 60-minute infusion protocol.
• The approval is supported by a multi-center non-inferiority study across 22 Canadian stroke centers, demonstrating comparable safety and efficacy to Activase in patients with disabling neurological deficits.
CareDx's AlloSeq cfDNA Test Shows Strong Performance in Large European Kidney Transplant Study
• A multicenter study of 580 kidney transplant patients demonstrates AlloSeq cfDNA's high accuracy in detecting allograft rejection, achieving an AUC of 0.758.
• The study validates AlloSeq cfDNA's performance consistency with CareDx's established AlloSure Kidney test across various clinical scenarios and timepoints.
• Results published in Transplant International confirm the test's reliability in monitoring post-transplant outcomes, supporting its clinical utility in transplant care.
CareDx's AlloHeme Test Shows 93% Sensitivity in Early Detection of AML and MDS Relapse Post-Transplant
• Interim results from the ACROBAT study demonstrate AlloHeme's superior accuracy in detecting post-transplant relapse in AML and MDS patients, with 93% sensitivity and 88% specificity.
• The NGS-based assay provides a median 36-day early warning before clinical relapse, potentially offering a crucial window for therapeutic intervention.
• AlloHeme significantly outperformed traditional STR testing methods, achieving an area under the curve of 0.90 compared to 0.74 and 0.61 for STR 1% and 5% respectively.
Breakthrough in Xenotransplantation: Genetically Modified Porcine Heart Transplanted into Human
A groundbreaking medical procedure was conducted where a genetically modified porcine heart was successfully transplanted into a human patient, marking a significant milestone in xenotransplantation research. This event was facilitated by the collaborative efforts of the University of Maryland Medical System, United Therapeutics, Inc., and various other contributors, showcasing the potential of genetic engineering in overcoming organ transplant shortages.
RSV Vaccines Show Weaker Immune Response in Immunocompromised Older Adults
• A recent study reveals that older, immunocompromised adults exhibit a weaker antibody response to RSV vaccines compared to healthy individuals.
• The research indicates that approximately 40% of immunocompromised participants did not achieve seroconversion or meet neutralization thresholds post-RSV vaccination.
• An adjuvanted vaccine (Arexvy) showed a tendency to induce higher levels of RSV-neutralizing antibodies compared to a non-adjuvanted vaccine (Abrysvo) in this population.
• Further research is needed to optimize RSV vaccine strategies, including timing and selection, for immunocompromised individuals to enhance protection.
Sana Biotechnology's HIP Technology Shows Promise in Type 1 Diabetes Islet Cell Transplant Study
• Sana Biotechnology's UP421 demonstrates survival and function of transplanted islet cells in a type 1 diabetes patient without immunosuppression.
• The first-in-human study shows HIP-engineered cells evade immune detection, producing insulin as indicated by increased C-peptide levels.
• MRI scans confirm graft survival 28 days post-transplantation, with no reported safety issues, suggesting potential for a curative T1D treatment.
• These results support the development of Sana's SC451, a stem cell-derived islet cell program, offering hope for scalable T1D therapies.
CareDx and TC BioPharm Partner to Enhance AlloCell Monitoring in AML Trial
• CareDx partners with TC BioPharm to perform pharmacokinetic analysis in the ACHIEVE clinical trial using its AlloCell solution.
• The ACHIEVE trial is a Phase II study evaluating TCB008, an allogeneic gamma-delta T-cell therapy, for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).
• AlloCell will assess the expansion and persistence of TCB008, providing insights into its duration and effect on immune system reconstitution in AML patients.
• The collaboration aims to advance allogeneic cell therapy and optimize TCB008 as a treatment for AML and other blood cancers.
Liso-cel Demonstrates Significant Response in Relapsed/Refractory Marginal Zone Lymphoma
• Bristol Myers Squibb's liso-cel achieved a statistically significant and clinically meaningful overall response rate in patients with relapsed or refractory marginal zone lymphoma.
• The Phase 2 trial results highlight the potential of liso-cel as an effective treatment option for this challenging patient population.
• The data were presented at the 2025 Tandem Meetings, showcasing advancements in cell therapy for hematological malignancies.
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