Clinical Trials
15
7 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
5
33.3%
Completed
2
13.3%
Not yet recruiting
2
13.3%
Terminated
1
6.7%
Unknown
4
26.7%
Withdrawn
1
6.7%
No approval data available
- CareDx reported second-quarter revenue of $132 million, a 52% year-over-year increase driven by demand across transplant programs and favorable reimbursement dynamics. - Adjusted net income more than tripled to $20 million, or $0.37 per share, significantly exceeding Wall Street's consensus estimate of $0.23 per share. - The company raised its full-year revenue outlook to $490–$500 million and adjusted EBITDA guidance to $66–$78 million, citing continued profitable growth. - CMS recently affirmed coverage for CareDx's surveillance testing for kidney, heart, and lung transplants, strengthening the reimbursement landscape.
- The global kidney transplant rejection biomarker market is projected to grow from USD 1,362.8 million in 2026 to USD 3,975.3 million by 2036 at an 11.3% CAGR, driven by increasing adoption of non-invasive liquid biopsy testing. - Donor-derived cell-free DNA (dd-cfDNA) is expected to hold 31.1% of the biomarker type segment in 2026, supported by blood-based sampling and measurable graft-derived injury signals across repeat surveillance visits. - A June 2024 Nature Medicine study covering 2,882 recipients across 14 centers has built confidence for liquid biopsy use in kidney transplant surveillance, accelerating clinical adoption. - Japan leads country-level growth at 13.7% CAGR, followed by the UK at 12.1% and the USA at 11.1%, with transplant centers projected to capture 44.0% of end-user share in 2026.
- CareDx presented over 30 abstracts and 9 oral presentations at ATC 2026, featuring data from more than 110 U.S. transplant centers on AlloSure and related precision diagnostics. - Persistent AlloSure elevation in the first four months post-kidney transplant was associated with higher rates of rejection, de novo DSA, eGFR decline, and graft loss at three years. - AlloSure demonstrated utility as a sensitive marker of ongoing graft injury in a tocilizumab study for antibody-mediated rejection, remaining elevated despite DSA reductions. - Integration of single-cell and spatial transcriptomics via ImmuneScape revealed distinct immune cell populations linked to kidney allograft rejection, advancing biomarker discovery.
- CareDx unveiled VANTx, a first-of-its-kind AI-powered clinical data analytics platform designed to transform complex transplant data into actionable insights for clinical research and real-world evidence generation. - The company announced a $170 million divestiture of its Lab Products business to EuroBio Scientific, allowing strategic focus on core Testing Services and Patient and Digital Solutions. - CareDx reported strong Q1 2026 preliminary results with 48% year-over-year growth in Testing Services revenue and 17% growth in testing volume. - VANTx operates on live data pipelines incorporating molecular tests and clinical trial data, built on Databricks environment leveraging Llama 3 foundational model for transplant program cohort analysis.
- CareDx announced successful clinical validation of AlloHeme, an AI-powered blood test that identifies cancer relapse in AML and MDS patients following allogeneic hematopoietic cell transplant with 85% sensitivity and 92% specificity. - The ACROBAT study demonstrated that AlloHeme detected relapse a median of 41 days earlier than clinical detection, with patients showing positive results having a 12-fold higher relapse risk at 6 months post-transplant. - The non-invasive NGS-based surveillance solution is expected to launch commercially in the U.S. in 2027 as part of CareDx's expansion into cell therapy and hematologic malignancy markets.
- CareDx and 10x Genomics have established ImmuneScape, a multiomics research initiative designed to elucidate the biology of transplant organ rejection and therapeutic response using cellular-resolution profiling. - The collaboration will utilize 10x Genomics' Xenium spatial and Chromium Flex single cell platforms to generate high-resolution maps of immune mechanisms underlying antibody-mediated rejection and microvascular inflammation. - The program aims to characterize disease origin and trajectory while informing treatment selection and therapeutic response, building on CareDx's recently introduced HistoMap Kidney gene expression classifier. - Insights generated from ImmuneScape are intended to support future clinical diagnostic development and advance personalized transplant medicine for improved patient outcomes.
- CareDx announced the launch of HistoMap Kidney, a tissue-based molecular test that uses gene expression profiling to objectively characterize rejection type and enhance biopsy results for kidney transplant patients. - New clinical data presented at ASN Kidney Week 2025 demonstrated that AlloSure Plus, an AI-powered rejection risk assessment tool, showed performance for predicting antibody-mediated rejection in kidney transplants. - Studies revealed that AlloSure levels remained consistent regardless of donor kidney size across 54 living donor recipients, supporting its use as a robust biomarker for allograft injury in both adult and pediatric patients. - Research showed that AlloSure and blood gene expression profiling were not affected by early graft function status, enabling rejection screening as early as week 1 post-transplant.
- CareDx published the largest prospective analysis of antibody-mediated rejection in heart transplantation, analyzing 2,240 patients across 59 U.S. transplant centers with 24,768 biopsies and 8,851 paired donor-derived cell-free DNA samples. - The SHORE study demonstrated that AlloSure Heart results ≥0.50% were highly specific (92.8%) for antibody-mediated rejection diagnosis, establishing new benchmarks in transplant diagnostics. - The study validated context-dependent thresholds that may safely reduce unnecessary biopsies for patients with low pre-test probability while supporting treatment response monitoring capabilities.
- 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 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.
