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CareDx, Inc. (CDNA)

CareDx, Inc. is a global innovator specializing in the discovery, development, and commercialization of diagnostic and management tools designed for transplant recipients and their healthcare providers. The company's extensive portfolio features a range of specialized diagnostic solutions for organ monitoring, including: AlloSure Kidney, AlloSure Heart, and AlloSure Lung: Advanced tests employing donor-derived cell-free DNA (dd-cfDNA) technology to assess the health of kidney, heart, and lung transplants, respectively. AlloMap Heart: A gene expression-based solution specifically for heart transplant patients. AlloSeq cfDNA: A broader surveillance tool to measure dd-cfDNA levels in the blood. CareDx also provides cutting-edge human leukocyte antigen (HLA) typing technologies, such as TruSight HLA, an NGS-based high-resolution typing solution; Olerup SSP, which uses sequence-specific primer technology for HLA allele typing; QTYPE for precise HLA typing; and AlloSeq Tx, another high-resolution HLA typing offering. For stem cell transplant recipients, the company offers AlloSeq HCT for chimerism testing. Beyond diagnostics, CareDx develops vital software and digital platforms to streamline transplant patient management. These include Ottr, a dedicated transplant patient management software; XynQAPI, focused on transplant quality tracking and waitlist management; and AlloCare, a mobile application serving as a patient-centric resource for those who have undergone transplantation. The company distributes its products directly to clients, as well as through a network of third-party distributors and sub-distributors. CareDx has forged significant partnerships, including a licensing agreement with Illumina, Inc. for the distribution, development, and commercialization of next-generation sequencing (NGS) products and technologies. Additionally, it collaborates with Cibiltech SAS to commercialize iBox, a software designed for the predictive analysis of kidney allograft loss post-transplantation. Founded in 1998, the company was initially known as XDx, Inc. before rebranding to CareDx, Inc. in March 2014. Its headquarters are located in South San Francisco, California.

Sector: Services-Medical Laboratories

Industry: Medical - Diagnostics & Research

CareDx, Inc logo

CareDx, Inc

NASDAQ:CDNAHealthcare
+22.22%$87.41
AH$87.81+0.46%vs close
Mkt Cap$4.59B
Float50.19M
O/S52.54M
Vol
$ Vol
RVOL
Inst Own99.9%
SI13.4%
Earnings
Dilution
CareDx, Inc logoNASDAQ:CDNA$87.41+22.22%
Phase Distribution
22 lead-sponsored trials·4 active·5 completed
Phase 11
Not applicable21
(15 more as collaborator)
Status Overview
Not yet recruiting3
Recruiting1
Active, not recruiting3
Completed5
Stopped3
Unknown7

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 1
    Not yet recruiting

    Hematopoietic Stem Cell Transplantation Gene Therapy for Treatment of Severe Hemophilia A

    Gene therapy

    Hemophilia A

    Enrollment
    7
    Start
    Sep 2024est.
    Primary Completion
    Aug 2029est.
    Completion
    Aug 2039est.
    NCT04418414
  • Not applicable
    Completed

    IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection

    AlloMap molecular expression testing, Right ventricular endomyocardial biopsy

    Graft Rejection, Heart Diseases

    Enrollment
    629
    Start
    Jan 2005
    Primary Completion
    -
    Completion
    Oct 2009
    NCT00351559
  • Observational
    Unknown status

    The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study

    non-interventional

    Systemic Lupus Erythematosus

    Enrollment
    1,000
    Start
    Dec 2007
    Primary Completion
    Jun 2010est.
    Completion
    Jun 2010est.
    NCT00671047
  • Observational
    Terminated

    Lung Allograft Rejection Gene Expression Observational (LARGO) Study

    Non-interventional

    Graft Rejection, Lung Disease

    Enrollment
    2,044
    Start
    Apr 2004
    Primary Completion
    Jan 2009est.
    Completion
    Jan 2009est.
    NCT00751309
  • Observational
    Completed

    Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

    -

    Graft Rejection, Heart Disease

    Enrollment
    800
    Start
    May 2005
    Primary Completion
    Feb 2009
    Completion
    Feb 2009
    NCT00761787
  • Not applicable
    Unknown status

    A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection Early Post-transplantation

    Endomyocardial biopsy, AlloMap Molecular Testing

    Graft Rejection, Heart Diseases

    Enrollment
    40
    Start
    Aug 2009
    Primary Completion
    Dec 2011est.
    Completion
    Dec 2011est.
    NCT00962377
  • Observational
    Unknown status

    Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing

    -

    Cardiac Transplant Failure, Cardiac Transplant Rejection +1

    Enrollment
    2,444
    Start
    Mar 2013
    Primary Completion
    Feb 2020est.
    Completion
    Feb 2020est.
    NCT01833195
  • Observational
    Completed

    Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling

    -

    Cardiac Transplant Failure, Cardiac Transplant Rejection +1

    Enrollment
    100
    Start
    Jun 2014
    Primary Completion
    Dec 2019
    Completion
    Feb 2020
    NCT02178943
  • Observational
    Unknown status

    Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

    -

    Kidney Transplant Recipients

    Enrollment
    401
    Start
    Apr 2015
    Primary Completion
    Aug 2018
    Completion
    Jan 2019est.
    NCT02424227
  • Observational
    Unknown status

    Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

    Donor-derived cell-free DNA (AlloSure®), Standard care

    Kidney Transplant Rejection

    Enrollment
    4,000
    Start
    Jan 2018
    Primary Completion
    Jun 2025est.
    Completion
    Dec 2025est.
    NCT03326076
  • Observational
    Active, not recruiting

    Surveillance HeartCare® Outcomes Registry

    Standard of Care

    Heart Transplant Rejection

    Enrollment
    2,743
    Start
    Dec 2018
    Primary Completion
    Nov 2026est.
    Completion
    Nov 2026est.
    NCT03695601
  • Observational
    Unknown status

    AlloSure Guided Immuno-Optimization for COVID-19: An Early Experience

    -

    Solid Organ Transplant Rejection, COVID-19

    Enrollment
    500
    Start
    Apr 2020est.
    Primary Completion
    Dec 2020est.
    Completion
    Mar 2021est.
    NCT04341103
  • Observational
    Unknown status

    Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance

    AlloSure

    Kidney Transplant Rejection

    Enrollment
    1,000
    Start
    Mar 2019
    Primary Completion
    Oct 2020est.
    Completion
    Oct 2020est.
    NCT04566055
  • Observational
    Completed

    Transition of Renal Patients Using AlloSure Into Community Kidney Care

    AlloSure

    Kidney Transplant Rejection

    Enrollment
    248
    Start
    Nov 2020
    Primary Completion
    Mar 2023
    Completion
    Oct 2023
    NCT04601155
  • Observational
    Completed

    Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test

    -

    Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia +1

    Enrollment
    307
    Start
    Jul 2021
    Primary Completion
    Sep 2026
    Completion
    Sep 2026
    NCT04635384
  • Observational
    Active, not recruiting

    Molecular Assessment and Profiling of Liver Transplant Recipients

    LiverCare

    Liver Transplantation, Biomarkers

    Enrollment
    1,500
    Start
    May 2021
    Primary Completion
    Dec 2027est.
    Completion
    Mar 2028est.
    NCT04793360
  • Observational
    Terminated

    Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient

    -

    Transplant

    Enrollment
    246
    Start
    Oct 2021
    Primary Completion
    Feb 2023
    Completion
    Jul 2023
    NCT05033548
  • Observational
    Active, not recruiting

    AlloSure Lung Assessment and Metagenomics Outcomes Study

    -

    Lung Transplant Infection, Lung Transplant; Complications +1

    Enrollment
    550
    Start
    Oct 2021
    Primary Completion
    Dec 2028est.
    Completion
    Dec 2028est.
    NCT05050955
  • Not applicable
    Withdrawn

    KidneyCare Immuno-optimization in Renal Allografts (KIRA)

    steroid, MMF

    Kidney Transplant, Immunosuppression +1

    Enrollment
    0
    Start
    Aug 2022est.
    Primary Completion
    Feb 2023est.
    Completion
    Feb 2023est.
    NCT05423496
  • Not applicable
    Not yet recruiting

    HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)

    HeartCare

    Heart Transplant, Immunosuppression +1

    Enrollment
    930
    Start
    Dec 2025est.
    Primary Completion
    Sep 2026est.
    Completion
    Sep 2026est.
    NCT05459181
  • Observational
    Enrolling by invitation

    Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)

    AlloHeme

    AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome) +1

    Enrollment
    400
    Start
    Sep 2026
    Primary Completion
    Dec 2029est.
    Completion
    Aug 2030est.
    NCT07607327
  • Not applicable
    Not yet recruiting

    Molecular Evidence of Rejection Intervention Trial

    Prednisone, Placebo

    Heart Transplant Rejection

    Enrollment
    200
    Start
    Mar 2027est.
    Primary Completion
    Dec 2028est.
    Completion
    Jun 2029est.
    NCT07905599
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